Clinical trial NCT03187626: Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Base-of-thumb Osteoarthritis
Keywords: Base-of-thumb osteoarthritis
Botulinum toxin A
Intra-articular therapy
Randomized trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
First posted: 2017-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in base-of-thumb pain 3 months post-injection
timeFrame: 3 months post injection
Secondary outcomes:
measure: Change in base-of-thumb pain 1 month post-injection
timeFrame: 1 month post injection
measure: Change in base-of-thumb pain 6 months post-injection
timeFrame: 6 months post injection
measure: Change in hand function 3 months post-injection
timeFrame: 3 months post injection
measure: Change in hand function 6 months post-injection
timeFrame: 6 months post injection
measure: Change in patient's global assessment 3 months post-injection
timeFrame: 3 months post-injection
measure: Change in patient's global assessment 6 months post-injection
timeFrame: 6 months post-injection
measure: Percentage of OARSI responders 3 months post-injection
timeFrame: 3 months post-injection
measure: Percentage of OARSI responders 6 months post-injection
timeFrame: 6 months post-injection
measure: Analgesics consumption at 3 months
timeFrame: from injection to 3 months post-injection
measure: Analgesics consumption at 6 months
timeFrame: from 3 to 6 months post-injection
measure: Non-steroidal anti-inflammatory drugs consumption at 3 months
timeFrame: from injection to 3 months post-injection
measure: Non-steroidal anti-inflammatory drugs consumption at 6 months
timeFrame: from 3 to 6 months post-injection
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Study officials:
affiliation: AP-HP , université Paris Descartes
name: François RANNOU, MD, PhD
role: STUDY_DIRECTOR
affiliation: AP-HP, université Paris Descartes
name: Christelle NGUYEN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gil C, Abdoul H, Campagna R, Guerini H, Ieong E, Chagny F, Bedin C, Roren A, Lefevre-Colau MM, Poiraudeau S, Feydy A, Rannou F, Nguyen C. Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337.