EUCTR2016-003939-38-FR
Active, not recruiting
Phase 1
Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study - RHIBOT
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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