RHIBOT: Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Base-of-thumb osteoarthritis is a common condition affecting middle-age persons. Base-of-thumb osteoarthritis induces pain and hand-specific limitations in activities. For short and midterm effects, therapeutic options usually include splinting, exercise therapy and intra-articular injections of glucocorticoids or hyaluronic acid. However, evidence of efficacy of intra-articular therapies in base-of-thumb osteoarthritis and international guidelines are inconsistent. Recently, the use of intra-articular botulinum toxin A as a pain killer has raised intense interest. The exact mechanisms of pain modulation by botulinum toxin A in osteoarthritis are unclear. It has been suggested that botulinum toxin A could directly reduce peripheral sensitization and indirectly reduce central sensitization. Indeed, recent studies suggest an inhibitory role of botulinum toxin A on the release of mediators involved in nociception, such as P substance, calcitonin gene-related peptide and glutamate. Open and randomized controlled trials of botulinum toxin A in knee osteoarthritis support short to mid-term positive clinical effects on pain. However, no study has reported results for base-of-thumb osteoarthritis
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intra-articular botulinum toxin A and splinting Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly |
Drug: botulinum toxin A
Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
Other Names:
|
| Active Comparator: Intra-articular saline and splinting Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly |
Drug: saline
Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
|
Outcome Measures
Primary Outcome Measures
- Change in base-of-thumb pain 3 months post-injection [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)
Secondary Outcome Measures
- Change in base-of-thumb pain 1 month post-injection [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)
- Change in base-of-thumb pain 6 months post-injection [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)
- Change in hand function 3 months post-injection [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)
- Change in hand function 6 months post-injection [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)
- Change in patient's global assessment 3 months post-injection [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)
- Change in patient's global assessment 6 months post-injection [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)
- Percentage of OARSI responders 3 months post-injection [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
- Percentage of OARSI responders 6 months post-injection [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
- Analgesics consumption at 3 months [from injection to 3 months post-injection]
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)
- Analgesics consumption at 6 months [from 3 to 6 months post-injection]
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)
- Non-steroidal anti-inflammatory drugs consumption at 3 months [from injection to 3 months post-injection]
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)
- Non-steroidal anti-inflammatory drugs consumption at 6 months [from 3 to 6 months post-injection]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years old
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Pain intensity on a self-administered 11-point pain numeric rating scale ≥ 30
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Pain involving the base-of-thumb
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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
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1990 American College of Rheumatology classification criteria for hand osteoarthritis adapted to base-of-thumb osteoarthritis
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Medical examination
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Written consent
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Health insurance
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For women of childbearing age, a negative urinary pregnancy test
Exclusion Criteria:
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History of thumb surgery
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History of inflammatory or crystal-associated rheumatic disease
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Neurological disorders involving the hands other than carpien canal syndrom
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Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
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Osteoarthritis predominating at the scaphotrapezial joint on X-Ray
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Hand or wrist trauma ≤ 2 months
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Hand or wrist intra-articular injections ≤ 2 months
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Contra-indication to botulinum toxin A injection or to splinting
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Cognitive or behavioral disorders making the assessment impossible
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Participant unable to speak, read and write french
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Bilateral BTOA without predominant symptomatic side
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Pregnancy and breast feeding
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin | Paris | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Investigators
- Study Director: François RANNOU, MD, PhD, AP-HP , université Paris Descartes
- Principal Investigator: Christelle NGUYEN, MD, PhD, AP-HP, université Paris Descartes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P160404