<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/NCT03821298</url>
  </required_header>
  <id_info>
    <org_study_id>14-2018</org_study_id>
    <nct_id>NCT03821298</nct_id>
  </id_info>
  <brief_title>Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis</brief_title>
  <acronym>CMC</acronym>
  <official_title>Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gannon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gannon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The&#xD;
      primary outcome of potential risk factors of osteoarthritis, pain and function will be&#xD;
      measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm,&#xD;
      Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy&#xD;
      Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs&#xD;
      Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and&#xD;
      Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12&#xD;
      months follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will start recruitment in April 2019.In this clinical trial, 50-100 females, aged&#xD;
      50 to 90 years of age, with a diagnosis of thumb CMC OA, will be recruited. The primary&#xD;
      outcome of potential risk factors of osteoarthritis, pain and function will be measured using&#xD;
      the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and&#xD;
      Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire&#xD;
      (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ),&#xD;
      Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI).&#xD;
      Measurements will be tak-en at the baseline, three, six and 12 months follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2020</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>Cohort Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline to 12 months Visual Analog Scale (VAS)</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>Pain scale VAS; 0: no pain, 100: maximum pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>Confidence in performing activities of daily living,They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident. A total score, ranging from 0 to 60, is calculated by adding the scores for each item. Higher scores reflect stronger self- efficacy beliefs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 12 months using the Tampa Scale of Kinesiophobia</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>measure of fear of movement, the total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia, and a cutoff score was developed by Vlaeyen (1995), where a score of 37or over is considered as a high score, while scores below that are considered as low scores. Use of a total score (including all 17 items) is recommended, although practitioners may wish to interpret results using two subscales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>self report measure of avoidance of activities of daily livin, The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance belief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to 12 months using the Hospital Anxiety and Depression Scale</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>Measure Depression and Anxiety,Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score indicates heightened anxiety or depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in from baseline to 12 months using the Impairment and Functioning Inventory</measure>
    <time_frame>baseline, three, six and 12 months follow up</time_frame>
    <description>Function, . It consists of 30 items with two related subscales: Daily Functioning and Impairment (perceived current level of functioning compared with the level of functioning before pain onset). 30 questions scored 0-4. Higher score indicates increased ability to perform activities of daily living</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pain</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care Hand Therapy</intervention_name>
    <description>8 sessions 2 times a week for 4 weeks</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <other_name>Orthosis</other_name>
    <other_name>Radial Nerve Gliding</other_name>
    <other_name>Joint Protection Education</other_name>
    <other_name>Proprioception exercises</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women older than 18 years&#xD;
&#xD;
          -  diagnosed with bilateral thumb CMC OA&#xD;
&#xD;
          -  a reported pain intensity during activities of daily living (ADLs) of up to 4 of 10 on&#xD;
             the visual analog scale (VAS)&#xD;
&#xD;
          -  The referring hand surgeon will made the diagnosis of CMC OA based on radiographs and&#xD;
             clinical exploration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurologic disorder affecting the upper limb&#xD;
&#xD;
          -  had received previous treatment for their hand problem in the last 6 months including&#xD;
             an intra-articular joint injection to wrist, fingers, or thumb&#xD;
&#xD;
          -  had fractures or a significant hand injury or previous surgery to the wrist or hand&#xD;
&#xD;
          -  had hand or finger tenosynovitis and/or Dupuytren disease&#xD;
&#xD;
          -  patients who did not complete any questionnaire or if they did not sign the informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristin Valdes, OTD, OT, CHT</last_name>
    <phone>813 6584901</phone>
    <email>valdes001@gannon.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gannon University</name>
      <address>
        <city>Ruskin</city>
        <state>Florida</state>
        <zip>33573</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristin A Valdes, OTD</last_name>
      <phone>813-658-4905</phone>
      <email>valdes001@gannon.edu</email>
    </contact>
    <investigator>
      <last_name>Nancy Naughton, OTD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.</citation>
    <PMID>11880847</PMID>
  </results_reference>
  <results_reference>
    <citation>Kerns RD, Sellinger J, Goodin BR. Psychological treatment of chronic pain. Annu Rev Clin Psychol. 2011;7:411-34. doi: 10.1146/annurev-clinpsy-090310-120430.</citation>
    <PMID>21128783</PMID>
  </results_reference>
  <results_reference>
    <citation>Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27. Erratum In: Ann Rheum Dis. 2018 Oct;77(10):1546.</citation>
    <PMID>21622766</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.</citation>
    <PMID>17046965</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gannon University</investigator_affiliation>
    <investigator_full_name>Kristin Valdes</investigator_full_name>
    <investigator_title>Assistant Professor of Occupational Therapy</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03821298
org study id: 14-2018
nct id: NCT03821298
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The
      primary outcome of potential risk factors of osteoarthritis, pain and function will be
      measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm,
      Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy
      Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs
      Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and
      Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12
      months follow up.
The study will start recruitment in April 2019.In this clinical trial, 50-100 females, aged
      50 to 90 years of age, with a diagnosis of thumb CMC OA, will be recruited. The primary
      outcome of potential risk factors of osteoarthritis, pain and function will be measured using
      the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and
      Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire
      (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ),
      Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI).
      Measurements will be tak-en at the baseline, three, six and 12 months follow up.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cohort Study
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline to 12 months Visual Analog Scale (VAS)
time frame: baseline, three, six and 12 months follow up
description: Pain scale VAS; 0: no pain, 100: maximum pain
measure: Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
time frame: baseline, three, six and 12 months follow up
description: Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction
measure: Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire
time frame: baseline, three, six and 12 months follow up
description: Confidence in performing activities of daily living,They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident. A total score, ranging from 0 to 60, is calculated by adding the scores for each item. Higher scores reflect stronger self- efficacy beliefs.
measure: Change from baseline to 12 months using the Tampa Scale of Kinesiophobia
time frame: baseline, three, six and 12 months follow up
description: measure of fear of movement, the total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia, and a cutoff score was developed by Vlaeyen (1995), where a score of 37or over is considered as a high score, while scores below that are considered as low scores. Use of a total score (including all 17 items) is recommended, although practitioners may wish to interpret results using two subscales
measure: Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire
time frame: baseline, three, six and 12 months follow up
description: self report measure of avoidance of activities of daily livin, The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance belief
measure: Change from baseline to 12 months using the Hospital Anxiety and Depression Scale
time frame: baseline, three, six and 12 months follow up
description: Measure Depression and Anxiety,Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score indicates heightened anxiety or depression
measure: Change in from baseline to 12 months using the Impairment and Functioning Inventory
time frame: baseline, three, six and 12 months follow up
description: Function, . It consists of 30 items with two related subscales: Daily Functioning and Impairment (perceived current level of functioning compared with the level of functioning before pain onset). 30 questions scored 0-4. Higher score indicates increased ability to perform activities of daily living
arm group label: Standard of Care
arm group type: Experimental
description: short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
intervention type: Other
intervention name: Standard of Care Hand Therapy
description: 8 sessions 2 times a week for 4 weeks
arm group label: Standard of Care
other name: Orthosis
other name: Radial Nerve Gliding
other name: Joint Protection Education
other name: Proprioception exercises
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kristin Valdes, OTD, OT, CHT
phone: 813 6584901
email: valdes001@gannon.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.
PMID: 11880847
citation: Kerns RD, Sellinger J, Goodin BR. Psychological treatment of chronic pain. Annu Rev Clin Psychol. 2011;7:411-34. doi: 10.1146/annurev-clinpsy-090310-120430.
PMID: 21128783
citation: Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27. Erratum In: Ann Rheum Dis. 2018 Oct;77(10):1546.
PMID: 21622766
citation: Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.
PMID: 17046965
responsible party type: Principal Investigator
investigator affiliation: Gannon University
investigator full name: Kristin Valdes
investigator title: Assistant Professor of Occupational Therapy
mesh term: Osteoarthritis
sharing ipd: No