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

NCT ID: NCT03187626

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2021-04-23

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

Conditions

Base-of-thumb Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

botulinum toxin A

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Botox®; Allergan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François RANNOU, MD, PhD

Role: STUDY_DIRECTOR

AP-HP , université Paris Descartes

Christelle NGUYEN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, université Paris Descartes

Locations

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

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 29961037 (View on PubMed)

Nguyen C, Abdoul H, Campagna R, Guerini H, Jilet L, Bedin C, Chagny F, Couraud G, Daste C, Drape JL, Flechon R, Gil C, Guerin C, Lefevre-Colau MM, Poiraudeau S, Randriamampandry E, Roren A, Feydy A, Rannou F. Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT). Lancet Rheumatol. 2022 Jul;4(7):e480-e489. doi: 10.1016/S2665-9913(22)00129-1.

Reference Type: DERIVED

PMID: 38294016 (View on PubMed)

Other Identifiers

P160404

Identifier Type: -

Identifier Source: org_study_id