<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984943</url>
  </required_header>
  <id_info>
    <org_study_id>FDG20160004H</org_study_id>
    <nct_id>NCT02984943</nct_id>
  </id_info>
  <brief_title>The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis</brief_title>
  <official_title>The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Grant U.S. Air Force Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>David Grant U.S. Air Force Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to determine the effects and ease of using hyperbaric&#xD;
      oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of&#xD;
      disease progression. In this study it is our intention to not only evaluate effects and ease&#xD;
      of treatment but time, cost, possible adverse events and effect size in an attempt to predict&#xD;
      an appropriate sample size and improve on the study design prior to a more extensive study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory disorder of unknown etiology&#xD;
      that primarily involves synovial joints, typically symmetrically. If untreated and/or&#xD;
      uncontrolled, joint destruction due to erosion of cartilage and bone can cause joint&#xD;
      destruction, joint deformities, loss of physical function, severe disability, and&#xD;
      difficulties maintaining employment. American College of Rheumatology (ACR)/EULAR 2010&#xD;
      classification criteria is a score-based algorithm which adds scores of 4 categories&#xD;
      including, joint involvement, serology, acute-phase reactants and duration of symptoms. A&#xD;
      score of &gt;6/10 is needed for classification of a patient as having definite RA.&#xD;
&#xD;
      Non-pharmacologic and supplementary therapies include patient education, rest, exercise,&#xD;
      nutrition counseling, cardiovascular disease risk reduction, and immunizations to decrease&#xD;
      risk of infectious complications of immunosuppression. These are important in the&#xD;
      comprehensive management of RA in all stages of disease and are used in addition to drug&#xD;
      therapy.&#xD;
&#xD;
      Pharmacologic therapies typically start with a disease-modifying anti-rheumatic drug (DMARD),&#xD;
      preferably as soon as possible after diagnosis. DMARDs are commonly used in combination with&#xD;
      anti-inflammatory drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and&#xD;
      glucocorticoids which are often used as bridging therapies until the DMARDs become effective.&#xD;
      The goal is disease remission. To assess response, disease activity scores are used along&#xD;
      with inflammatory markers.&#xD;
&#xD;
      Three patients with active RA treated in the multi-place hyperbaric facility at David Grant&#xD;
      Medical Center (DGMC), Travis Air Force Base, California, for non RA-related indications, all&#xD;
      noted significant improvement in arthralgias, sleep patterns and overall well-being during&#xD;
      the course of therapy. Two were treated at 2 atmospheres absolute (ATA) oxygen for 90 minutes&#xD;
      daily Monday through Friday. One patient received 2 ATA air on the same treatment protocol as&#xD;
      a participant in a research study, and a subsequent course of hyperbaric oxygen (HBO2) at 2&#xD;
      ATA.&#xD;
&#xD;
      This is a pilot study. Patients will be recruited through the Rheumatologists, IRB-approved&#xD;
      HIPAA waiver to contact patients that have been seen in the military treatment facility (MTF)&#xD;
      within the past year with a diagnosis of RA, flyers in the Rheumatology Clinic or thru&#xD;
      Commander Calls.&#xD;
&#xD;
      During the initial screening visit:&#xD;
&#xD;
      The rheumatologist will discuss the trial and at this point the subject will be consented and&#xD;
      the inclusion/exclusion criteria will be reviewed. If subject qualifies they will see the&#xD;
      Hyperbaric physician who will do physical examination to determine if it is safe for the&#xD;
      subject to receive HBO2. An human chorionic gonadotrophin (HCG) by point of care testing&#xD;
      (POCT) will be completed by the coordinator in women capable of pregnancy. After this exam is&#xD;
      done the subject will be scheduled for a trial Hyperbaric session.&#xD;
&#xD;
      Baseline visit will be done after the subject has tolerated the trial hyperbaric session.&#xD;
      This visit includes:&#xD;
&#xD;
        1. A visit with the rheumatologist to do routine assessments to establish baseline&#xD;
           measurement using the Disease Activity Scale (DAS28)&#xD;
&#xD;
        2. Labs (CRP and Erythrocyte Sedimentation Rate (ESR), basic metabolic panel (BMP) and&#xD;
           microparticles), will be completed. Magnetic resonance imaging (MRI) with and without&#xD;
           contrast and ultrasound will be done on both hands from wrists to proximal phalanges the&#xD;
           wrist. BMP is done pre-MRI to guarantee adequate kidney function.&#xD;
&#xD;
        3. Subjective patient reporting will be captured using the Routine Assessment of Patient&#xD;
           Index Data (RAPID 3)&#xD;
&#xD;
        4. Sleep quality will be tracked using the Pain and Sleep Quality Questionnaire (PSQ-3).&#xD;
&#xD;
        5. Visual Analog Scores (VAS) for pain will be tracked.&#xD;
&#xD;
        6. Surveys will be done by a study team member&#xD;
&#xD;
      The subject at this time will be scheduled to start HBO2 treatments. Screening, baseline,&#xD;
      first HBO2 treatment all in one month. Participants will complete 30 sessions within 10&#xD;
      weeks.&#xD;
&#xD;
      If the subject reports pain relief (&gt; 40% or zero pain) during the HBO2 treatments the will&#xD;
      be referred to the rheumatologist for assessment. Pain improvement will be based on a pain&#xD;
      assessment (1-10 scale reported verbally) at hyperbaric treatment visits. Labs will be drawn&#xD;
      at this time. RAPID 3, PSQ-3 and VAS will be done at least six times while undergoing HBO2&#xD;
      treatment to track subject progress. Labs (CRP, ESR, microparticles) will be repeated at the&#xD;
      conclusion of the HBO2 treatments.&#xD;
&#xD;
      At the month 3 and month 6 visit (+/- 2 week window) the subject will see the rheumatologist&#xD;
      to track disease activity using the DAS-28. The date of the visit will be scheduled for three&#xD;
      and six months from the baseline visit. The rheumatologist will order the MRI, ultrasound and&#xD;
      lab studies prior to the visit. RAPID 3, PSQ-3 and VAS will be administered at this time. Lab&#xD;
      samples will be collected prior to the Rheumatology appointment.&#xD;
&#xD;
      The six month visit marks the end of the trial. Patients will continue to be followed in&#xD;
      Rheumatology Clinic every three months.&#xD;
&#xD;
      If the patient's RA symptoms worsen during the study, the physicians will institute measures&#xD;
      to address the cause. The medical monitor will be notified and if any adverse events are&#xD;
      involved, they will be recorded and reported to the Institutional Review Board (IRB).&#xD;
&#xD;
      Data:&#xD;
&#xD;
      Data will be entered by authorized study personnel only. Demographic information will be&#xD;
      collected including sex, age and ethnic background in accordance with HIPPA compliance.&#xD;
&#xD;
      Data collected during this study will be analyzed at various points in time to include&#xD;
      physician exams, labs (CRP, ESR, BMP, analysis of microparticles, neutrophil and platelet&#xD;
      activation), radiologic studies, joint inspection.&#xD;
&#xD;
      Changes in joint pain will be determined by self-reporting and results of the standard&#xD;
      outcome measures questionnaires (RAPID 3, PSQ-3 and VAS). A separate sleep survey will be&#xD;
      administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">April 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality - Trouble Falling Asleep, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot; is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality - Trouble Falling Asleep, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality - Morning Pain, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality - Morning Pain, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality - Night Pain, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Quality - Night Pain, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - Global Health (GH), 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm.&quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - Global Health (GH), 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - C-reactive Protein (CRP), 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - C-reactive Protein (CRP), 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Abilities, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Abilities, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Pain, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Pain, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Illness/Health, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Illness/Health, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Cumulative Scores, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Cumulative Scores, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Weighed Scores, 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RAPID 3 - Weighed Scores, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS Pain Scale - 6 Weeks</measure>
    <time_frame>6 weeks</time_frame>
    <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS Pain Scale - 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Synovitis, Combined Score (CS), Right, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Synovitis, Combined Score (CS), Right, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Synovitis, Combined Score (CS), Left, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Synovitis, Combined Score (CS), Left, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Bone Erosion, Combined Score (CS), Right, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Bone Erosion, Combined Score (CS), Right, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Bone Erosion, Combined Score (CS), Left, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Bone Erosion, Combined Score (CS), Left, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Oedema, Combined Score (CS), Left, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Oedema, Combined Score (CS), Left, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Oedema, Combined Score (CS), Right, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI - Oedema, Combined Score (CS), Right, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the t month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at t months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>RheumatoId Arthritis</condition>
  <arm_group>
    <arm_group_label>Hyperbaric Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperbaric Oxygen</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyperbaric Oxygen</intervention_name>
    <description>30 treatments of Hyperbaric Oxygen.</description>
    <arm_group_label>Hyperbaric Oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18&#xD;
&#xD;
          2. Active duty or Department of Defense (DoD) beneficiary&#xD;
&#xD;
          3. Diagnosed with rheumatoid arthritis meeting ACR/EULAR 2010 classification criteria and&#xD;
             any one of the following:&#xD;
&#xD;
               1. Patient does not want to be on rheumatologic medications&#xD;
&#xD;
               2. Patient has contraindications to standard rheumatologic medications&#xD;
&#xD;
               3. Patient has failed treatment or an incomplete response with standard&#xD;
                  rheumatologic medications&#xD;
&#xD;
          4. Women of childbearing age must have a negative pregnancy test and currently be on a&#xD;
             reliable form of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe depression&#xD;
&#xD;
          2. Dementia, mental disability&#xD;
&#xD;
          3. Claustrophobia&#xD;
&#xD;
          4. Uncontrolled seizure disorder&#xD;
&#xD;
          5. Uncontrolled asthma/severe chronic obstructive pulmonary disease (COPD) with partial&#xD;
             pressure of carbon dioxide (pCO2) &gt; 45 mmHg on arterial blood gas&#xD;
&#xD;
          6. Grade 4 congestive heart failure&#xD;
&#xD;
          7. Unstable angina&#xD;
&#xD;
          8. Chronic/acute otitis media/sinusitis&#xD;
&#xD;
          9. Major tympanic membrane trauma&#xD;
&#xD;
         10. Severe kyphoscoliosis&#xD;
&#xD;
         11. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusion capacity&#xD;
             of the lung for carbon monoxide (DLCO) after a single hyperbaric oxygen exposure&#xD;
&#xD;
         12. History of renal insufficiency or glomerular filtration rate (GFR)&lt; 30&#xD;
&#xD;
         13. Women that are currently pregnant or breast feeding or intend on becoming pregnant&#xD;
             while enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle T Sit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>David Grant Medical Center. Travis AFB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David Grant Medical Center</name>
      <address>
        <city>Travis Air Force Base</city>
        <state>California</state>
        <zip>94535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.medicalgasresearch.com/conten/5/1/9</url>
    <description>Hyperbaric oxygen in chronic traumatic brain injury: oxygen, pressure, and gene therapy</description>
  </link>
  <link>
    <url>http://www.das-score.nl</url>
    <description>Disease activity score for rheumatoid arthritis.</description>
  </link>
  <link>
    <url>https://www.uptodate.com/contents/assessment-of-rheumatoid-arthritis-activity-in-clinical-trials-and-clinical-practice?source=search_result&amp;search=assessment%20of%20reumatoid%20arthritis%20activity%20in%20clinical%20trial%20and%20clinical%20practive&amp;selectedTitle=2~150</url>
    <description>Approaches to the management of rheumatoid arthritis</description>
  </link>
  <link>
    <url>https://www.uptodate.com/contents/general-principles-of-management-of-rheumatoid-arthritis-in-adults?source=search_result&amp;search=general%20principles%20of%20management%20of%20rheumatoid%20arthritis%20in%20adults&amp;selectedTitle=1~150</url>
    <description>The treatment of rheumatoid arthritis (RA) is directed toward the control of synovitis and the prevention of joint injury.</description>
  </link>
  <link>
    <url>http://archive.rubicon-foundation.org/xmlui/handle/123456789/7257</url>
    <description>50 patients treated with traditional drug therapy with the addition of Hyperbaric Oxygen</description>
  </link>
  <link>
    <url>http://rheumatology.oxfordjournals.org/content/27/1/72.1.extract</url>
    <description>citation regarding hyperbaric and rheumatoid arthritis.</description>
  </link>
  <reference>
    <citation>Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.</citation>
    <PMID>20699241</PMID>
  </reference>
  <reference>
    <citation>Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.</citation>
    <PMID>22891194</PMID>
  </reference>
  <reference>
    <citation>Pincus T, Swearingen C, Wolfe F. Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum. 1999 Oct;42(10):2220-30. doi: 10.1002/1529-0131(199910)42:103.0.CO;2-5.</citation>
    <PMID>10524697</PMID>
  </reference>
  <results_reference>
    <citation>Varga OIu, Ignat'ev VK, Vezikova NN, Kheifetz IV. [Radiation-modifying effect of oxygen barotherapy in complex treatment of patients with rheumatoid arthritis and osteoarthrosis]. Ter Arkh. 2002;74(12):83-6. Russian.</citation>
    <PMID>12577851</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>January 29, 2020</results_first_submitted>
  <results_first_submitted_qc>March 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2020</results_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>David Grant U.S. Air Force Medical Center</investigator_affiliation>
    <investigator_full_name>Michelle Sit, MD</investigator_full_name>
    <investigator_title>Rheumatologist</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Hyperbaric Oxygen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02984943/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hyperbaric Oxygen</title>
          <description>Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 14 participants were enrolled. 3 participants withdrew. 1 physician decision</population>
      <group_list>
        <group group_id="B1">
          <title>Hyperbaric Oxygen</title>
          <description>Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>3 participant withdrew&#xD;
1 physician decision</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age &gt;/= 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.3" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>3 participant withdrew&#xD;
1 physician decision</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>3 participants withdrew&#xD;
1 physician decision</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosed with rheumatoid arthritis meeting ACR/EULAR 2010 classification and 1 other criteria</title>
          <description>additional criteria (at least one)&#xD;
Patient does not want to be on rheumatologic medications.&#xD;
Patient has contraindications to standard rheumatologic medications.&#xD;
Patient has failed treatment or an incomplete response with standard rheumatologic medications.</description>
          <population>3 participants withdrew&#xD;
1 physician decision</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Trouble Falling Asleep, 6 Weeks</title>
        <description>The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot; is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Trouble Falling Asleep, 6 Weeks</title>
          <description>The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot; is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.5" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.10</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Trouble Falling Asleep, 6 Months</title>
        <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Trouble Falling Asleep, 6 Months</title>
          <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you had trouble falling asleep because of pain?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.5" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.10</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Morning Pain, 6 Weeks</title>
        <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Morning Pain, 6 Weeks</title>
          <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.3" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Morning Pain, 6 Months</title>
        <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Morning Pain, 6 Months</title>
          <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the morning?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Night Pain, 6 Weeks</title>
        <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Night Pain, 6 Weeks</title>
          <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.5" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Quality - Night Pain, 6 Months</title>
        <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality - Night Pain, 6 Months</title>
          <description>The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question &quot;How often have you been awakened by pain during the night?&quot; by placing a slash (/) on a 10 cm line directly beneath the question. The line will have &quot;never&quot; and &quot;always&quot; at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - Global Health (GH), 3 Months</title>
        <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm.&quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - Global Health (GH), 3 Months</title>
          <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm.&quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="15" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2938</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - Global Health (GH), 6 Months</title>
        <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - Global Health (GH), 6 Months</title>
          <description>DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="10" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2938</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - C-reactive Protein (CRP), 3 Months</title>
        <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - C-reactive Protein (CRP), 3 Months</title>
          <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.3" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0608</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - C-reactive Protein (CRP), 6 Months</title>
        <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - C-reactive Protein (CRP), 6 Months</title>
          <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.2" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0608</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months</title>
        <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months</title>
          <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2.3" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1496</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months</title>
        <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months</title>
          <description>DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). &quot;0&quot;is a better outcome, and &quot;100&quot; is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="3.0" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1496</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Abilities, 6 Weeks</title>
        <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Abilities, 6 Weeks</title>
          <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.0" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Abilities, 6 Months</title>
        <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Abilities, 6 Months</title>
          <description>A questionnaire that assesses abilities on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="0.7" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Pain, 6 Weeks</title>
        <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Pain, 6 Weeks</title>
          <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.5" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Pain, 6 Months</title>
        <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Pain, 6 Months</title>
          <description>A questionnaire that assesses pain on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0.5" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Illness/Health, 6 Weeks</title>
        <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Illness/Health, 6 Weeks</title>
          <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="0.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Illness/Health, 6 Months</title>
        <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Illness/Health, 6 Months</title>
          <description>A questionnaire that assesses illness/health on a scale of 0-10. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Cumulative Scores, 6 Weeks</title>
        <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Cumulative Scores, 6 Weeks</title>
          <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" lower_limit="2.7" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0068</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Cumulative Scores, 6 Months</title>
        <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Cumulative Scores, 6 Months</title>
          <description>The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. &quot;0&quot;is a better outcome, and &quot;30&quot; is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="2.0" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0068</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Weighed Scores, 6 Weeks</title>
        <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Weighed Scores, 6 Weeks</title>
          <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="1.0" upper_limit="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0183</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>RAPID 3 - Weighed Scores, 6 Months</title>
        <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>RAPID 3 - Weighed Scores, 6 Months</title>
          <description>The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="0.7" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0183</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>VAS Pain Scale - 6 Weeks</title>
        <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Pain Scale - 6 Weeks</title>
          <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.825" upper_limit="2.925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>VAS Pain Scale - 6 Months</title>
        <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Pain Scale - 6 Months</title>
          <description>A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints &quot;no pain&quot; to &quot;worse possible pain&quot;. &quot;0&quot;is a better outcome, and &quot;10&quot; is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.625" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Skillings-Mack test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Synovitis, Combined Score (CS), Right, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Synovitis, Combined Score (CS), Right, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Synovitis, Combined Score (CS), Right, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Synovitis, Combined Score (CS), Right, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Synovitis, Combined Score (CS), Left, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Synovitis, Combined Score (CS), Left, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Synovitis, Combined Score (CS), Left, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Synovitis, Combined Score (CS), Left, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Bone Erosion, Combined Score (CS), Right, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Bone Erosion, Combined Score (CS), Right, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Bone Erosion, Combined Score (CS), Right, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Bone Erosion, Combined Score (CS), Right, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Bone Erosion, Combined Score (CS), Left, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Bone Erosion, Combined Score (CS), Left, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Bone Erosion, Combined Score (CS), Left, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Bone Erosion, Combined Score (CS), Left, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;10&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Oedema, Combined Score (CS), Left, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Oedema, Combined Score (CS), Left, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Oedema, Combined Score (CS), Left, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Oedema, Combined Score (CS), Left, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Oedema, Combined Score (CS), Right, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Oedema, Combined Score (CS), Right, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>MRI - Oedema, Combined Score (CS), Right, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI - Oedema, Combined Score (CS), Right, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the 6 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 6 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
        <time_frame>3 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered &quot;improved&quot; for the 3 month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at 3 months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months</title>
        <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the t month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at t months</description>
        <time_frame>6 months</time_frame>
        <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyperbaric Oxygen</title>
            <description>30 treatments of Hyperbaric Oxygen.</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months</title>
          <description>Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. &quot;0&quot; is best outcome, &quot;3&quot;worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered &quot;improved&quot; for the t month time point. The number of participants with &quot;improved&quot; scores will be added to form the total number with improvement at t months</description>
          <population>10 participants imaged. 1 unable to analyze due to fusion on imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Descriptive statistics only were used</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hyperbaric Oxygen</title>
          <description>30 treatments of Hyperbaric Oxygen.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Left knee pain</sub_title>
                <description>Diagnosed as ilio-tibial band syndrome associated with activity</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial Lung Disease (ILD)</sub_title>
                <description>ILD is a condition associated with Rheumatoid Arthritis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diffuse pruritus &amp; popular rash</sub_title>
                <description>Onset of symptoms following carpal tunnel surgery, 26 Jul 18</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michelle Sit</name_or_title>
      <organization>David Grant Medical Center, Travis Air Force Base</organization>
      <phone>707-423-3875</phone>
      <email>michelle.t.sit.mil@mail.mil</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984943
org study id: FDG20160004H
nct id: NCT02984943
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this investigation is to determine the effects and ease of using hyperbaric
      oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of
      disease progression. In this study it is our intention to not only evaluate effects and ease
      of treatment but time, cost, possible adverse events and effect size in an attempt to predict
      an appropriate sample size and improve on the study design prior to a more extensive study.
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory disorder of unknown etiology
      that primarily involves synovial joints, typically symmetrically. If untreated and/or
      uncontrolled, joint destruction due to erosion of cartilage and bone can cause joint
      destruction, joint deformities, loss of physical function, severe disability, and
      difficulties maintaining employment. American College of Rheumatology (ACR)/EULAR 2010
      classification criteria is a score-based algorithm which adds scores of 4 categories
      including, joint involvement, serology, acute-phase reactants and duration of symptoms. A
      score of >6/10 is needed for classification of a patient as having definite RA.

      Non-pharmacologic and supplementary therapies include patient education, rest, exercise,
      nutrition counseling, cardiovascular disease risk reduction, and immunizations to decrease
      risk of infectious complications of immunosuppression. These are important in the
      comprehensive management of RA in all stages of disease and are used in addition to drug
      therapy.

      Pharmacologic therapies typically start with a disease-modifying anti-rheumatic drug (DMARD),
      preferably as soon as possible after diagnosis. DMARDs are commonly used in combination with
      anti-inflammatory drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and
      glucocorticoids which are often used as bridging therapies until the DMARDs become effective.
      The goal is disease remission. To assess response, disease activity scores are used along
      with inflammatory markers.

      Three patients with active RA treated in the multi-place hyperbaric facility at David Grant
      Medical Center (DGMC), Travis Air Force Base, California, for non RA-related indications, all
      noted significant improvement in arthralgias, sleep patterns and overall well-being during
      the course of therapy. Two were treated at 2 atmospheres absolute (ATA) oxygen for 90 minutes
      daily Monday through Friday. One patient received 2 ATA air on the same treatment protocol as
      a participant in a research study, and a subsequent course of hyperbaric oxygen (HBO2) at 2
      ATA.

      This is a pilot study. Patients will be recruited through the Rheumatologists, IRB-approved
      HIPAA waiver to contact patients that have been seen in the military treatment facility (MTF)
      within the past year with a diagnosis of RA, flyers in the Rheumatology Clinic or thru
      Commander Calls.

      During the initial screening visit:

      The rheumatologist will discuss the trial and at this point the subject will be consented and
      the inclusion/exclusion criteria will be reviewed. If subject qualifies they will see the
      Hyperbaric physician who will do physical examination to determine if it is safe for the
      subject to receive HBO2. An human chorionic gonadotrophin (HCG) by point of care testing
      (POCT) will be completed by the coordinator in women capable of pregnancy. After this exam is
      done the subject will be scheduled for a trial Hyperbaric session.

      Baseline visit will be done after the subject has tolerated the trial hyperbaric session.
      This visit includes:

        1. A visit with the rheumatologist to do routine assessments to establish baseline
           measurement using the Disease Activity Scale (DAS28)

        2. Labs (CRP and Erythrocyte Sedimentation Rate (ESR), basic metabolic panel (BMP) and
           microparticles), will be completed. Magnetic resonance imaging (MRI) with and without
           contrast and ultrasound will be done on both hands from wrists to proximal phalanges the
           wrist. BMP is done pre-MRI to guarantee adequate kidney function.

        3. Subjective patient reporting will be captured using the Routine Assessment of Patient
           Index Data (RAPID 3)

        4. Sleep quality will be tracked using the Pain and Sleep Quality Questionnaire (PSQ-3).

        5. Visual Analog Scores (VAS) for pain will be tracked.

        6. Surveys will be done by a study team member

      The subject at this time will be scheduled to start HBO2 treatments. Screening, baseline,
      first HBO2 treatment all in one month. Participants will complete 30 sessions within 10
      weeks.

      If the subject reports pain relief (> 40% or zero pain) during the HBO2 treatments the will
      be referred to the rheumatologist for assessment. Pain improvement will be based on a pain
      assessment (1-10 scale reported verbally) at hyperbaric treatment visits. Labs will be drawn
      at this time. RAPID 3, PSQ-3 and VAS will be done at least six times while undergoing HBO2
      treatment to track subject progress. Labs (CRP, ESR, microparticles) will be repeated at the
      conclusion of the HBO2 treatments.

      At the month 3 and month 6 visit (+/- 2 week window) the subject will see the rheumatologist
      to track disease activity using the DAS-28. The date of the visit will be scheduled for three
      and six months from the baseline visit. The rheumatologist will order the MRI, ultrasound and
      lab studies prior to the visit. RAPID 3, PSQ-3 and VAS will be administered at this time. Lab
      samples will be collected prior to the Rheumatology appointment.

      The six month visit marks the end of the trial. Patients will continue to be followed in
      Rheumatology Clinic every three months.

      If the patient's RA symptoms worsen during the study, the physicians will institute measures
      to address the cause. The medical monitor will be notified and if any adverse events are
      involved, they will be recorded and reported to the Institutional Review Board (IRB).

      Data:

      Data will be entered by authorized study personnel only. Demographic information will be
      collected including sex, age and ethnic background in accordance with HIPPA compliance.

      Data collected during this study will be analyzed at various points in time to include
      physician exams, labs (CRP, ESR, BMP, analysis of microparticles, neutrophil and platelet
      activation), radiologic studies, joint inspection.

      Changes in joint pain will be determined by self-reporting and results of the standard
      outcome measures questionnaires (RAPID 3, PSQ-3 and VAS). A separate sleep survey will be
      administered.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sleep Quality - Trouble Falling Asleep, 6 Weeks
time frame: 6 weeks
description: The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you had trouble falling asleep because of pain?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0" is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks
measure: Sleep Quality - Trouble Falling Asleep, 6 Months
time frame: 6 months
description: The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you had trouble falling asleep because of pain?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months.
measure: Sleep Quality - Morning Pain, 6 Weeks
time frame: 6 weeks
description: The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the morning?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: Sleep Quality - Morning Pain, 6 Months
time frame: 6 months
description: The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the morning?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: Sleep Quality - Night Pain, 6 Weeks
time frame: 6 weeks
description: The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the night?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: Sleep Quality - Night Pain, 6 Months
time frame: 6 months
description: The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the night?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: DAS28 - Global Health (GH), 3 Months
time frame: 3 months
description: DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm."0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months
measure: DAS28 - Global Health (GH), 6 Months
time frame: 6 months
description: DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months
measure: DAS28 - C-reactive Protein (CRP), 3 Months
time frame: 3 months
description: DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months
measure: DAS28 - C-reactive Protein (CRP), 6 Months
time frame: 6 months
description: DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months
measure: DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months
time frame: 3 months
description: DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months
measure: DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months
time frame: 6 months
description: DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months
measure: RAPID 3 - Abilities, 6 Weeks
time frame: 6 weeks
description: A questionnaire that assesses abilities on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks.
measure: RAPID 3 - Abilities, 6 Months
time frame: 6 months
description: A questionnaire that assesses abilities on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: RAPID 3 - Pain, 6 Weeks
time frame: 6 weeks
description: A questionnaire that assesses pain on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: RAPID 3 - Pain, 6 Months
time frame: 6 months
description: A questionnaire that assesses pain on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: RAPID 3 - Illness/Health, 6 Weeks
time frame: 6 weeks
description: A questionnaire that assesses illness/health on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: RAPID 3 - Illness/Health, 6 Months
time frame: 6 months
description: A questionnaire that assesses illness/health on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: RAPID 3 - Cumulative Scores, 6 Weeks
time frame: 6 weeks
description: The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. "0"is a better outcome, and "30" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: RAPID 3 - Cumulative Scores, 6 Months
time frame: 6 months
description: The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. "0"is a better outcome, and "30" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: RAPID 3 - Weighed Scores, 6 Weeks
time frame: 6 weeks
description: The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: RAPID 3 - Weighed Scores, 6 Months
time frame: 6 months
description: The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: VAS Pain Scale - 6 Weeks
time frame: 6 weeks
description: A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints "no pain" to "worse possible pain". "0"is a better outcome, and "10" is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks
measure: VAS Pain Scale - 6 Months
time frame: 6 months
description: A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints "no pain" to "worse possible pain". "0"is a better outcome, and "10" is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months
measure: MRI - Synovitis, Combined Score (CS), Right, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Synovitis, Combined Score (CS), Right, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: MRI - Synovitis, Combined Score (CS), Left, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Synovitis, Combined Score (CS), Left, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: MRI - Bone Erosion, Combined Score (CS), Right, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Bone Erosion, Combined Score (CS), Right, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: MRI - Bone Erosion, Combined Score (CS), Left, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Bone Erosion, Combined Score (CS), Left, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: MRI - Oedema, Combined Score (CS), Left, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Oedema, Combined Score (CS), Left, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: MRI - Oedema, Combined Score (CS), Right, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: MRI - Oedema, Combined Score (CS), Right, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months
measure: Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months
time frame: 3 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months
measure: Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months
time frame: 6 months
description: Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the t month time point. The number of participants with "improved" scores will be added to form the total number with improvement at t months
arm group label: Hyperbaric Oxygen
arm group type: Experimental
description: Hyperbaric Oxygen
intervention type: Device
intervention name: Hyperbaric Oxygen
description: 30 treatments of Hyperbaric Oxygen.
arm group label: Hyperbaric Oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle T Sit, MD
role: Principal Investigator
affiliation: David Grant Medical Center. Travis AFB
facility: 
country: United States
url: http://www.medicalgasresearch.com/conten/5/1/9
description: Hyperbaric oxygen in chronic traumatic brain injury: oxygen, pressure, and gene therapy
url: http://www.das-score.nl
description: Disease activity score for rheumatoid arthritis.
url: https://www.uptodate.com/contents/assessment-of-rheumatoid-arthritis-activity-in-clinical-trials-and-clinical-practice?source=search_result&search=assessment%20of%20reumatoid%20arthritis%20activity%20in%20clinical%20trial%20and%20clinical%20practive&selectedTitle=2~150
description: Approaches to the management of rheumatoid arthritis
url: https://www.uptodate.com/contents/general-principles-of-management-of-rheumatoid-arthritis-in-adults?source=search_result&search=general%20principles%20of%20management%20of%20rheumatoid%20arthritis%20in%20adults&selectedTitle=1~150
description: The treatment of rheumatoid arthritis (RA) is directed toward the control of synovitis and the prevention of joint injury.
url: http://archive.rubicon-foundation.org/xmlui/handle/123456789/7257
description: 50 patients treated with traditional drug therapy with the addition of Hyperbaric Oxygen
url: http://rheumatology.oxfordjournals.org/content/27/1/72.1.extract
description: citation regarding hyperbaric and rheumatoid arthritis.
citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.
PMID: 20699241
citation: Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.
PMID: 22891194
citation: Pincus T, Swearingen C, Wolfe F. Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum. 1999 Oct;42(10):2220-30. doi: 10.1002/1529-0131(199910)42:103.0.CO;2-5.
PMID: 10524697
citation: Varga OIu, Ignat'ev VK, Vezikova NN, Kheifetz IV. [Radiation-modifying effect of oxygen barotherapy in complex treatment of patients with rheumatoid arthritis and osteoarthrosis]. Ter Arkh. 2002;74(12):83-6. Russian.
PMID: 12577851
responsible party type: Principal Investigator
investigator affiliation: David Grant U.S. Air Force Medical Center
investigator full name: Michelle Sit, MD
investigator title: Rheumatologist
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 