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 range18 Years
SexALL
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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…
What they're measuring
1
Change in base-of-thumb pain 3 months post-injection