Base-of-thumb Osteoarthritis Clinical Trial
— RHIBOTOfficial title:
Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study
| Verified date | June 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 23, 2021 |
| Est. primary completion date | February 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 epilepsy |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Recherche Clinique Paris Descartes Necker Cochin Sainte Anne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in base-of-thumb pain 3 months post-injection | Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain) | 3 months post injection | |
| Secondary | Change in base-of-thumb pain 1 month post-injection | Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain) | 1 month post injection | |
| Secondary | Change in base-of-thumb pain 6 months post-injection | Mean change from baseline in average base-of-thumb pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain - 100 maximal pain) | 6 months post injection | |
| Secondary | Change in hand function 3 months post-injection | Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations) | 3 months post injection | |
| Secondary | Change in hand function 6 months post-injection | Mean change from baseline in average hand-specific limitations in activities in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0 no limitations - 90 maximal limitations) | 6 months post injection | |
| Secondary | Change in patient's global assessment 3 months post-injection | Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible) | 3 months post-injection | |
| Secondary | Change in patient's global assessment 6 months post-injection | Mean change from baseline in patient's global assessment on a self-administered 11-point numeric rating scale (0 worst possible - 100 best possible) | 6 months post-injection | |
| Secondary | Percentage of OARSI responders 3 months post-injection | OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) = 50% and absolute change = 20/100 on pain numeric rating scale or = 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain = 20% and absolute change = 10/100, 2/ function = 20% and absolute change = 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) = 20% and absolute change = 10/100 | 3 months post-injection | |
| Secondary | Percentage of OARSI responders 6 months post-injection | OARSI response is defined as an improvement in pain (0 to 100 numeric rating scale) or in function (0 to 90 Cochin Hand Function Scale) = 50% and absolute change = 20/100 on pain numeric rating scale or = 9/90 on Cochin Hand Function Scale respectively , or improvement in at least 2 of the 3 following items: 1/ pain = 20% and absolute change = 10/100, 2/ function = 20% and absolute change = 9/90, 3/ patient's global assessment (0 to 100 numeric rating scale) = 20% and absolute change = 10/100 | 6 months post-injection | |
| Secondary | Analgesics consumption at 3 months | Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily) | from injection to 3 months post-injection | |
| Secondary | Analgesics consumption at 6 months | Self-reported consumption of analgesics (non-opioid, weak and strong opioids) using a self-administered 4-class scale (never; several times a month; several times a week; daily) | from 3 to 6 months post-injection | |
| Secondary | Non-steroidal anti-inflammatory drugs consumption at 3 months | Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily) | from injection to 3 months post-injection | |
| Secondary | Non-steroidal anti-inflammatory drugs consumption at 6 months | Self-reported consumption of non-steroidal anti-inflammatory drugs using a self-administered 4-class scale (never; several times a month; several times a week; daily) | from 3 to 6 months post-injection |