xml: <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/NCT05961800</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY23040122</org_study_id>
      <nct_id>NCT05961800</nct_id>
    </id_info>
    <brief_title>Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks</brief_title>
    <acronym>OMEGA</acronym>
    <official_title>OMEGA Study: Offset Mechanisms in Evaluation of Lumbar Medial Branch Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pittsburgh</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study examines the relationship between central nervous system (CNS) mechanisms of pain&#xD;
        inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study examines the relationship between central nervous system (CNS) mechanisms of pain&#xD;
        inhibition and the pain relief that occurs following a commonly-performed nerve block used to&#xD;
        diagnose and treat chronic low back pain. Patients scheduled for lumbar medial branch blocks&#xD;
        as part of routine clinical care will arrive to clinic prior to the block for quantitative&#xD;
        sensory testing procedures that measure CNS pain modulation. Patients will then undergo&#xD;
        treatment as usual with their block, subsequently reporting low back pain intensity in a pain&#xD;
        diary.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>
      <intervention_model_description>Quantitative Sensory Testing</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Offset analgesia and onset hyperalgesia</measure>
      <time_frame>during this portion of the study visit (30 minutes)</time_frame>
      <description>Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low back pain intensity change</measure>
      <time_frame>Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block</time_frame>
      <description>Patients respond to the question &quot;How would you rate your back pain right now?&quot; from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is each hour after the lumbar medial branch block.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of low back pain</measure>
      <time_frame>Baseline</time_frame>
      <description>Participant self-reports the number of years they have experienced low back pain. The number of years for each participant will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PEG: A Three-Item Scale Assessing Pain Intensity and Interference</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported average pain and pain interference within past 7 days. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine). Total scores range from 0-30, and higher scores indicate more pain interference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline Back Pain Intensity</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for determining how much a person hurts with a question ranked on a 11-point scale, from &quot;0 = no pain&quot; to &quot;10 = worst imaginable pain.&quot; The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS Pain Interference 4a</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported consequences of pain with 4 questions ranked on a 5-point scale, from &quot;not at all&quot; to &quot;very much&quot;. The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS Physical Function- 6b</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from &quot;without any difficulty&quot; to &quot;unable to do&quot; or &quot;not at all&quot; to &quot;cannot do.&quot; The minimum raw summed score is 6 and the maximum score is 30.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS Sleep Disturbance 6a</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. Lower scores suggest better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6-item Pain Catastrophizing Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>Standardized survey score assessing pain perception before the study procedures begin. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-2)</measure>
      <time_frame>Baseline</time_frame>
      <description>The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. The PHQ-2 includes the first two items of the PHQ-9. A PHQ-2 score ranges from 0-6. The authors identified a score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression.&#xD;
  If the score is 3 or greater, major depressive disorder is likely.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS 4-item Depression</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from &quot;never&quot; to &quot;always&quot;. The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS 4-item Anxiety</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for self-reported fear, anxious misery, hyperarousal, and somatic symptoms with 4 questions ranked on a 5-point scale, from &quot;never&quot; to &quot;always&quot;. The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Areas of Pain Body Map</measure>
      <time_frame>Baseline</time_frame>
      <description>The digital body figure contains 36 anterior regions and 38 posterior regions on which participants can mark areas in which they experience chronic pain. The number of pain areas each participant recorded will be reported, with a possibility of 74 total regions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Expectancy</measure>
      <time_frame>Baseline</time_frame>
      <description>Assessment for the subject's expectations of treatment effec prior to lumbar medial branch block. Scores range from 0 (not at all) to 4 (very much), with total scores ranging from 0-24. Higher scores indicate higher expectations of the low back pain treatement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change</measure>
      <time_frame>Immediately after lumbar medial branch block</time_frame>
      <description>The subject's impression of the impact of the lumbar medial branch block on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Situational pain catastrophizing scale (S-PCS)</measure>
      <time_frame>Immediately after lumbar medial branch block</time_frame>
      <description>Standardized survey score assessing pain perception immediately following the lumbar medial branch block. Scores range from 0-24, with higher scores representing more pain catastrophizing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity during QST</measure>
      <time_frame>during this portion of the study visit (60 minutes)</time_frame>
      <description>Changes in pain intensity during quantitative sensory tests measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline back pain intensity</measure>
      <time_frame>baseline</time_frame>
      <description>Patients respond to the question &quot;How would you rate your back pain on average?&quot; from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is before the lumbar medial branch block.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Back pain intensity after lumbar medial branch block</measure>
      <time_frame>Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block</time_frame>
      <description>Patients respond to the question &quot;How would you rate your back pain right now?&quot; from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is each hour after the lumbar medial branch block.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Pain, Chronic</condition>
    <condition>Facet Joint Pain</condition>
    <condition>Pain, Procedural</condition>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>Quantitative Sensory Testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cutaneous Probe</intervention_name>
      <description>A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.</description>
      <arm_group_label>Quantitative Sensory Testing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Quantitative Sensory Testing</intervention_name>
      <description>Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain</description>
      <arm_group_label>Quantitative Sensory Testing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Computer Tasks</intervention_name>
      <description>Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.</description>
      <arm_group_label>Quantitative Sensory Testing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Scheduled for lumbar MBB in UPMC Pain Management clinics&#xD;
  &#xD;
            -  Age &gt; 18 years old&#xD;
  &#xD;
            -  Predominantly axial chronic low back pain at least 3 months on a daily basis&#xD;
  &#xD;
            -  Must meet the minimum criteria for cognitive function using the PROMIS 2-item&#xD;
               cognitive screener (&gt;3)&#xD;
  &#xD;
            -  Low back pain intensity of &gt; 3/10&#xD;
  &#xD;
            -  Willing and able to receive study-related phone calls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of spine surgery at the level of the lumbar MBB&#xD;
  &#xD;
            -  Active worker's compensation or litigation claims&#xD;
  &#xD;
            -  New pain and/or psychiatric treatments within 2 weeks of enrollment&#xD;
  &#xD;
            -  Not fluent in English and/or not able to complete the questionnaires&#xD;
  &#xD;
            -  Any clinically unstable systemic illness that is judged to interfere with 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>Benedict J Alter, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maya L Maurer, BS</last_name>
      <phone>412-665-8052</phone>
      <email>mam708@pitt.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Benedict J Alter, MD, PhD</last_name>
      <phone>412-677-0575</phone>
      <email>alterbj@upmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UPMC St. Margaret</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maya L Maurer, BS</last_name>
        <phone>412-665-8052</phone>
        <email>mam708@pitt.edu</email>
      </contact>
      <contact_backup>
        <last_name>Benedict J Alter, MD, PhD</last_name>
        <phone>412-677-0575</phone>
        <email>alterbj@upmc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Benedict J Alter, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Benedict Alter</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>lumbar</keyword>
    <keyword>medial branch block</keyword>
    <keyword>offset analgesia</keyword>
    <keyword>onset hyperalgesia</keyword>
    <keyword>QST</keyword>
    <keyword>quantitative sensory testing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthralgia</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Pain, Procedural</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data will be available, including data dictionaries, after publication per journal and funding protocols. The statistical analysis plan and analytic code will also be available per the same protocols.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available after publication per journal and funding entity protocols.</ipd_time_frame>
      <ipd_access_criteria>Data will be made available by reasonable request and/or per journal and funding entity protocols.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961800
  org study id: STUDY23040122
  nct id: NCT05961800
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study examines the relationship between central nervous system (CNS) mechanisms of pain
        inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).
  This study examines the relationship between central nervous system (CNS) mechanisms of pain
        inhibition and the pain relief that occurs following a commonly-performed nerve block used to
        diagnose and treat chronic low back pain. Patients scheduled for lumbar medial branch blocks
        as part of routine clinical care will arrive to clinic prior to the block for quantitative
        sensory testing procedures that measure CNS pain modulation. Patients will then undergo
        treatment as usual with their block, subsequently reporting low back pain intensity in a pain
        diary.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Quantitative Sensory Testing
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Offset analgesia and onset hyperalgesia
  time frame: during this portion of the study visit (30 minutes)
  description: Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline
  measure: Low back pain intensity change
  time frame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
  description: Patients respond to the question "How would you rate your back pain right now?" from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is each hour after the lumbar medial branch block.
  measure: Duration of low back pain
  time frame: Baseline
  description: Participant self-reports the number of years they have experienced low back pain. The number of years for each participant will be reported.
  measure: PEG: A Three-Item Scale Assessing Pain Intensity and Interference
  time frame: Baseline
  description: Assessment for self-reported average pain and pain interference within past 7 days. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine). Total scores range from 0-30, and higher scores indicate more pain interference.
  measure: Baseline Back Pain Intensity
  time frame: Baseline
  description: Assessment for determining how much a person hurts with a question ranked on a 11-point scale, from "0 = no pain" to "10 = worst imaginable pain." The minimum raw summed score is 0 and the maximum score is 10. Lower raw response scores suggest lower pain intensity and better outcomes.
  measure: PROMIS Pain Interference 4a
  time frame: Baseline
  description: Assessment for self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.
  measure: PROMIS Physical Function- 6b
  time frame: Baseline
  description: Assessment for self-reported capability with 6 qualitatively scaled questions ranked on a 5-point scale, from "without any difficulty" to "unable to do" or "not at all" to "cannot do." The minimum raw summed score is 6 and the maximum score is 30.
  measure: PROMIS Sleep Disturbance 6a
  time frame: Baseline
  description: Assessment for self-reported perceptions of sleep quality and sleep depth with 6 questions ranked on a 5-point scale. The minimum raw summed score is 6 and the maximum score is 30. Lower scores suggest better outcomes.
  measure: 6-item Pain Catastrophizing Scale
  time frame: Baseline
  description: Standardized survey score assessing pain perception before the study procedures begin. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing.
  measure: Patient Health Questionnaire (PHQ-2)
  time frame: Baseline
  description: The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. The PHQ-2 includes the first two items of the PHQ-9. A PHQ-2 score ranges from 0-6. The authors identified a score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression.
  If the score is 3 or greater, major depressive disorder is likely.
  measure: PROMIS 4-item Depression
  time frame: Baseline
  description: Assessment for self-reported negative mood and views of self with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower t-scores suggest better outcomes.
  measure: PROMIS 4-item Anxiety
  time frame: Baseline
  description: Assessment for self-reported fear, anxious misery, hyperarousal, and somatic symptoms with 4 questions ranked on a 5-point scale, from "never" to "always". The minimum raw summed score is 4 and the maximum score is 20. Lower scores suggest better outcomes.
  measure: Areas of Pain Body Map
  time frame: Baseline
  description: The digital body figure contains 36 anterior regions and 38 posterior regions on which participants can mark areas in which they experience chronic pain. The number of pain areas each participant recorded will be reported, with a possibility of 74 total regions.
  measure: Treatment Expectancy
  time frame: Baseline
  description: Assessment for the subject's expectations of treatment effec prior to lumbar medial branch block. Scores range from 0 (not at all) to 4 (very much), with total scores ranging from 0-24. Higher scores indicate higher expectations of the low back pain treatement.
  measure: Patient Global Impression of Change
  time frame: Immediately after lumbar medial branch block
  description: The subject's impression of the impact of the lumbar medial branch block on their pain and function will be measured with a 7-item scale (1 = very much worse, 2 = much worse, 3 = minimally worse, 4 = no change, 5 = minimally improved, 6 = much improved, 7 = very much improved).
  measure: Situational pain catastrophizing scale (S-PCS)
  time frame: Immediately after lumbar medial branch block
  description: Standardized survey score assessing pain perception immediately following the lumbar medial branch block. Scores range from 0-24, with higher scores representing more pain catastrophizing.
  measure: Pain intensity during QST
  time frame: during this portion of the study visit (60 minutes)
  description: Changes in pain intensity during quantitative sensory tests measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)
  measure: Baseline back pain intensity
  time frame: baseline
  description: Patients respond to the question "How would you rate your back pain on average?" from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is before the lumbar medial branch block.
  measure: Back pain intensity after lumbar medial branch block
  time frame: Immediately after lumbar medial branch block and up to 16 hours after lumbar medial branch block
  description: Patients respond to the question "How would you rate your back pain right now?" from 0 (no pain) to 10 (worst imaginable pain) to see how intense their back pain is each hour after the lumbar medial branch block.
  arm group label: Quantitative Sensory Testing
  arm group type: Experimental
  description: Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.
  intervention type: Behavioral
  intervention name: Cutaneous Probe
  description: A computer-controlled probe delivers temperatures to the skin to measure pain, offset analgesia and onset hyperalgesia.
  arm group label: Quantitative Sensory Testing
  intervention type: Behavioral
  intervention name: Quantitative Sensory Testing
  description: Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain
  arm group label: Quantitative Sensory Testing
  intervention type: Behavioral
  intervention name: Computer Tasks
  description: Quantitative Sensory Testing (QST) and computer tasks are used to measure changes in pain intensity.
  arm group label: Quantitative Sensory Testing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benedict J Alter, MD, PhD
  role: Principal Investigator
  affiliation: University of Pittsburgh
  last name: Maya L Maurer, BS
  phone: 412-665-8052
  email: mam708@pitt.edu
  last name: Benedict J Alter, MD, PhD
  phone: 412-677-0575
  email: alterbj@upmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Benedict Alter
  investigator title: Assistant Professor
  mesh term: Arthralgia
  mesh term: Chronic Pain
  mesh term: Pain, Procedural
  sharing ipd: Yes
  ipd description: Individual participant data will be available, including data dictionaries, after publication per journal and funding protocols. The statistical analysis plan and analytic code will also be available per the same protocols.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will become available after publication per journal and funding entity protocols.
  ipd access criteria: Data will be made available by reasonable request and/or per journal and funding entity protocols.