Efficacy of an Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis

Assistance Publique - Hôpitaux de Paris60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Base-of-thumb Osteoarthritis

Interventions

botulinum toxin ADRUG

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

salineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin

Paris, Paris, France

Outcomes

Primary Outcomes

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)

Time frame: 3 months post injection

Secondary Outcomes

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)

Time frame: 1 month post injection

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)

Time frame: 6 months post injection

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)

Time frame: 3 months post injection

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)

Time frame: 6 months post injection

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.