Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis (NCT03821298) | Clinical Trial Compass
UnknownNot Applicable
Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis
United States50 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to 12 months Visual Analog Scale (VAS)
Timeframe: baseline, three, six and 12 months follow up
2
Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
Timeframe: baseline, three, six and 12 months follow up