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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06902805
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OnabotulinumtoxinA — DRUG
    intra-articular injection
  • Normal saline (placebo) — DRUG
    intra-articular injection

Study Details

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.

Key Dates

First listed
Mar 30, 2025
Start date
Dec 3, 2025
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 intra-articular injections of onabotulinumtoxinA
  • Experimental: 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline
  • Placebo Comparator: 2 intra-articular injections of normal saline

Primary Outcome Measure

Base-of-thumb pain on a self-administered 11-point numeric rating scale [ Time Frame: 6 months ]

Central Contacts

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