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Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis (CMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821298
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
University of Malaga
Information provided by (Responsible Party):
Kristin Valdes, Gannon University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Osteoarthritis Other: Standard of Care Hand Therapy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Standard of Care
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
Other: Standard of Care Hand Therapy
8 sessions 2 times a week for 4 weeks
Other Names:
  • Orthosis
  • Radial Nerve Gliding
  • Joint Protection Education
  • Proprioception exercises




Primary Outcome Measures :
  1. Change from baseline to 12 months Visual Analog Scale (VAS) [ Time Frame: baseline, three, six and 12 months follow up ]
    Pain scale VAS; 0: no pain, 100: maximum pain

  2. Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand [ Time Frame: baseline, three, six and 12 months follow up ]
    Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction


Secondary Outcome Measures :
  1. Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire [ Time Frame: baseline, three, six and 12 months follow up ]
    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.

  2. Change from baseline to 12 months using the Tampa Scale of Kinesiophobia [ Time Frame: baseline, three, six and 12 months follow up ]
    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

  3. Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire [ Time Frame: baseline, three, six and 12 months follow up ]
    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

  4. Change from baseline to 12 months using the Hospital Anxiety and Depression Scale [ Time Frame: baseline, three, six and 12 months follow up ]
    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

  5. Change in from baseline to 12 months using the Impairment and Functioning Inventory [ Time Frame: baseline, three, six and 12 months follow up ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women older than 18 years
  • diagnosed with bilateral thumb CMC OA
  • a reported pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
  • The referring hand surgeon will made the diagnosis of CMC OA based on radiographs and clinical exploration.

Exclusion Criteria:

  • neurologic disorder affecting the upper limb
  • had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
  • had fractures or a significant hand injury or previous surgery to the wrist or hand
  • had hand or finger tenosynovitis and/or Dupuytren disease
  • patients who did not complete any questionnaire or if they did not sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821298


Contacts
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Contact: Kristin Valdes, OTD, OT, CHT 813 6584901 valdes001@gannon.edu

Locations
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United States, Florida
Gannon University Recruiting
Ruskin, Florida, United States, 33573
Contact: Kristin A Valdes, OTD    813-658-4905    valdes001@gannon.edu   
Sub-Investigator: Nancy Naughton, OTD         
Sponsors and Collaborators
Gannon University
University of Malaga
Publications of Results:
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Responsible Party: Kristin Valdes, Assistant Professor of Occupational Therapy, Gannon University
ClinicalTrials.gov Identifier: NCT03821298    
Other Study ID Numbers: 14-2018
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristin Valdes, Gannon University:
pain
osteoarthritis
function
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases