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

NCT03187626 | Completed Phase 2

• 1 other identifier: P160404
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Base-of-thumb Osteoarthritis

Keywords

Base-of-thumb osteoarthritis; Botulinum toxin A; Intra-articular therapy; Randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in base-of-thumb pain 1 month post-injection

  1 month post injection

• Change in base-of-thumb pain 6 months post-injection

  6 months post injection

• Change in hand function 3 months post-injection

  3 months post injection

• Change in hand function 6 months post-injection

  6 months post injection

• Change in patient's global assessment 3 months post-injection

  3 months post-injection

Study Arms (2)

Intra-articular botulinum toxin A and splinting

EXPERIMENTAL

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

Intra-articular saline and splinting

ACTIVE COMPARATOR

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

Interventions

botulinum toxin A 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

Also known as: Botox®, Allergan

Intra-articular botulinum toxin A and splinting

saline 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

Intra-articular saline and splinting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (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, 75014, France

Location

Related Publications (2)

• 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.

  PMID: 29961037 BACKGROUND

• 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.

  PMID: 38294016 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A; Idoxuridine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• François RANNOU, MD, PhD

  AP-HP , université Paris Descartes

  STUDY DIRECTOR

• Christelle NGUYEN, MD, PhD

  AP-HP, université Paris Descartes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: November 29, 2018
• Primary Completion: February 16, 2021
• Study Completion: April 23, 2021
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)