Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting for base-of-thumb osteoarthritis on pain at 3 months

Phase 1

• Conditions: Patients referred to our Physical Medicine Rehabilitation Department of a tertiary care center in Paris, France, for the management of Base-of-thumb osteoarthritis (BTOA); MedDRA version: 20.0Level: LLTClassification code 10062893Term: RhizarthrosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-003939-38-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-15
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patient aged >/= 18 years
Symptoms involving the base-of-thumb
Mean base-of-thumb pain intensity in the previous 48 hours on NRS >/= 30
Radiographic evidence of at least 2 of 4 radiographic items: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts
Physical examination findings consistent with BTOA
Written consent
Health cover

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

- History of thumb surgery
- History of inflammatory or crystal-associated rheumatic disease involving the hands
- Neurological disorders involving the hands
- Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
- Ostearthritis affecting the scaphotrapezial joint
- Hand or wrist trauma - Hand or wrist intra-articular injections - Contra-indications to BTA injections or splinting
- Cognitive or behavioral disorders making the assessment impossible
- Inability to speak or write French
- Bilateral rhizarthrosis without dominant affected site
- Pregnancy and breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified