Thumb Osteoarthritis Prognosis for Supported Self-managment (NCT05932628) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thumb Osteoarthritis Prognosis for Supported Self-managment
United Kingdom150 participantsStarted 2023-08-08
Plain-language summary
Background Thumb base osteoarthritis (OA) is common in adults 40 years and over. It affects a person's ability to work, be independent and care for others. Sufferers complain of severe pain and difficulty in completing everyday tasks. The main treatment for the condition is advice on how a person can manage their condition (self-management), reduce their pain, strengthen their hands with exercises and practical tips on tackling painful tasks, sometimes providing a hand splint for support. The treatment is provided by occupational and physiotherapists. We know that this treatment helps suffers in the short term (up to three months). But the research was done in people with few other health problems and while self-management support helps provide pain relief for most people, there are some people who don't benefit. The aim of this research is to see how pain and other hand problems change over a period of six months after the start of treatment, to understand people's experience of care, and examine why some people improve, and some do not.
Research Plan In patients receiving treatment for thumb base OA at four NHS sites, who are willing to take part, this research will: -
1. Record changes in symptoms and quality of life at three and six months from when treatment began in a postal questionnaire/survey.
2. Discuss the experience of care and people's beliefs about what makes treatment a success by interviewing a small group of patients.
3. Analyse patient characteristics, to see if it is possible to determine how they will respond to treatment.
4. Develop recommendations for improving care.
Who can participate
Age range
30 Years
Sex
ALL
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:
* Symptomatic thumb base OA, confirmed with at least one of the following clinical signs:
* Hard tissue enlargement of the thumb carpometacarpal joint
* Squaring at the base of the thumb
* Crepitus on movement of the thumb carpometacarpal joint
* Positive adduction provocation test
* Positive extension provocation test
* Positive pressure shear test
* Pain on palpation of the dorso-radial aspect of the thumb carpometacarpal joint
* Able to give written informed consent.
* Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions.
Exclusion Criteria:
* Currently receiving therapy care for thumb base OA.
* Fractures or significant injury or surgery to the wrist or hand on the included side in the previous 6 months.
* Previous surgery to the basal thumb joint on the included side.
* Red flags i.e., diagnosed rheumatic condition (gout, rheumatoid arthritis), progressive neurological signs, any acutely swollen hand joint, serious illness, or disease.
* Participants of any drug or medical device trial in the last 12 weeks.
* Recent steroid injection in their included basal thumb joint (2 months prior to baseline appointment).
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
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain Subscale
Timeframe: 6 months
Trial details
NCT IDNCT05932628
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust