Assessment of Pain After Botulinum Toxin Injections in Osteoarthritis of the thumb

Phase 2

Completed

• Conditions: Osteoarthritis of the first carpometacarpal joint

• Registration Number: 2024-517280-23-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nice

Brief Summary

To show that botulinum toxin injection is superior to placebo injection in improving pain in symptomatic trapezometacarpal osteoarthritis at 3 months

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patient >18 years old

Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode

Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.

Visual analog scale (VAS) of pain > 4

Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices

Exclusion Criteria

History of surgery of the thumb column

Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months

Patient who has received a Botulinum toxin injection at any site within the last 3 months

Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder

Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.		Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Centre Hospitalier Universitaire De Nice

🇫🇷Nice, France

Pierre BLANC

Site contact

+33492039655

blanc.p@chu-nice.fr