Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-… (NCT03187626) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
France60 participantsStarted 2018-11-29
Plain-language summary
The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.
Who can participate
Age range
18 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:
* Age ≥ 18 years old
* Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
* Pain involving the base-of-thumb
* X-ray evidence of base-of-thumb osteoarthritis with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
* 1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
* Medical examination
* Written consent
* Health insurance
* For women of childbearing age, a negative urinary pregnancy test
Exclusion Criteria:
* History of thumb surgery
* History of inflammatory or crystal-associated rheumatic disease
* Neurological disorders involving the hands other than carpien canal syndrom
* Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
* Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
* Hand or wrist trauma ≤ 2 months
* Hand or wrist intra-articular injections ≤ 2 months
* Contra-indication to botulinum toxin A injection or to splinting
* Cognitive or behavioral disorders making the assessment impossible
* Participant unable to speak, read and write french
* Bilateral BTOA without predominant symptomatic side
* Pregnancy and breast feeding
* Persons referred to in Articles L 1121-5; 6; 8; 9 of the Public Health Code (protected minors or adults, guardianship or trusteeship, etc.)
* Patient with epilep…
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 in base-of-thumb pain 3 months post-injection