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Clinical Trials/EUCTR2016-003939-38-FR
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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites60 target enrollmentJune 15, 2017
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.

Registry
who.int
Start Date
June 15, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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