Evaluation of pain after intra-articular injections of botulinum toxin in carpometacarpal osteoarthritis of the thumb
- Conditions
- RhizarthrosisMedDRA version: 20.0Level: LLTClassification code 10062893Term: RhizarthrosisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2020-002127-10-FR
- Lead Sponsor
- CHU de Nice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
-Patient aged 18 and over
-Patient with thumb carpometacarpal osteoarthritis objectified clinically by questionnaire and X-ray with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
-Patient giving his written consent
-Visual analog pain scale > 4
-Patient in failure of well-conducted drug treatment including analgesics and anti-inflammatories
-Patients must have stopped all corticosteroid therapy or NSAIDs within the last 48 hours
-Patient affiliated to a social security scheme
-Patient likely to understand the instructions of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
-Patient with a history of surgery of the thumb
-Patient who has received corticoid and others injections in the thumb carpometacarpal acid in last 6 months
-Patient who has received a botulinum toxin injection from any site in last 3 months
-Patient with myasthenia gravis or Lambert Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe breathing disorder or severe swallowing disorder
-Patient with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
-Patient with infection or inflammation at the injection site concerned
-Pregnant or lactating woman (a urine pregnancy test will be performed)
-Patient with a history of inflammatory or crystal-associated rheumatic
-Participation in another clinical trial and at least 30 days before
-Any medical or psychiatric condition that may prevent the proper understanding and conduct of treatment and study (major under guardianship)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine that the botulinum toxin injection is better than the placebo injection to improve pain in symptomatic trapeziometacarpal osteoarthritis at 3 months;Secondary Objective: - Determine that the effects of a trapeziometacarpal injection of TB are superior to placebo on function (Dreiser test, Kapandji index, Jamar Hydraulic Pinch Gauge), quality of sleep and quality of life at M3<br>- Evaluate the tolerance of TB in rizarthrosis<br>- Determine that the effects of a trapezo-metacarpal injection of TB are superior to placebo on rhizarthrosis pain at 8 weeks (8 weeks = M1.5) (telephone interview)<br>- Determine that TB injection reduces the consumption of analgesic and anti-inflammatory drugs over the study period (placebo vs TB period)<br>;Primary end point(s): Pain assessment at 3 months;Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Evaluation of the Dreiser test, quality of sleep and quality of life at 3 months<br>- Collect side effects<br>- Pain assessment at 8 weeks<br>- Evaluate the use of analgesic and anti-inflammatory drugs during the study period<br>;Timepoint(s) of evaluation of this end point: at least 3 months after injection