Status:
ACTIVE_NOT_RECRUITING
Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Rhizarthrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Only 4 randomized controlled clinical trials have been published to date to assess the short-term effectiveness of intra-articular Botulinum Toxin injection on pain, function and quality of life in pa...
Eligibility Criteria
Inclusion
- 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.
- Patient with signed informed consent.
- 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
- Patients must have stopped all corticosteroid or non-steroidal anti-inflammatory drugs therapy within the last 48 hours.
- Patient affiliated with a Social Security plan
- Patient who can understand the study instructions
- Patient on effective contraception for more than one month according to the marketing authorization (Pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant)
- Infertile patients in connection with surgery (tubal ligation, oophorectomy, adnexectomy, hysterectomy)
Exclusion
- 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)
- Patient with an infection or inflammation at the injection site concerned
- Pregnant or breastfeeding women (a urine pregnancy test will be performed)
- Patients with chronic inflammatory joint disease or microcrystalline pathology
- Current participation or less than 30 days of participation in a clinical drug trial
- Any medical or psychiatric condition that could prevent the proper understanding and conduct of the treatment and study (adult under guardianship)
- Patient who wishes to discontinue contraception during the study
- Patients at high risk of bleeding complications from the intra-articular injection (hemophilia, anticoagulant treatment, etc.)
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04829565
Start Date
September 9 2021
End Date
May 15 2026
Last Update
December 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Nice
Nice, PACA, France, 06000