Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

Recruiting Phase 2 Phase 3 Interventional Study
Base-of-thumb Osteoarthritis Osteoarthritis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial

The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * • Individuals aged at least 18 years; * Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain); * Pain involving the base of the thumb; * X-ray evidence of trapezometacarpial osteoarthritis with at least…
Contacts

Christelle NGUYEN, MD, PhD

01 58 41 29 45

christelle.nguyen2@aphp.fr

CONTACT

Laetitia PEAUDECERF, PhD

01 58 41 12 13

laetitia.peaudecerf@aphp.fr

CONTACT