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 patients suffering from chronic knee pain related or not to knee osteoarthritis and also in the context of ankle osteoarthritis. The analgesic properties and the reported safety make intra-articular Botulinum toxin a strong candidate in the treatment of symptomatic manifestations of osteoarthritis disease and more particularly in certain locations such as the trapezo-metacarpal joint. Investigators hypothesize that injection of intra-articular Botulinum toxin into the trapezo-metacarpal joint will be of benefit in reducing pain and improving function in patients with rhizarthrosis. Investigators will begin a monocentric randomized controlled trial comparing intra-articular injections of Botulinum toxin and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU
echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo
CHU de Nice
Nice, PACA, France
Visual Analogue Scale at 3 months
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.
Time frame: 3 months after the injection
Dreiser test evaluation
Dreiser test evaluation (functional index evaluation) at 3 months
Time frame: 3 months after the injection
adverse events
Collecting adverse events
Time frame: through study completion, an average of 3 months
Visual Analogue Scale at 8 weeks
Evaluation of pain by Visual Analogue Scale at 8 weeks. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
Time frame: 8 weeks after the injection
intake of analgesic and anti-inflammatory drugs during the study period
Evaluate the intake of analgesic and anti-inflammatory drugs during the study period: collection of the consumption of analgesics and non-steroidal anti-inflammatory drugs in the patient's diary (international non-proprietary name, dosage, date and time) from the injection at Month 0 to the evaluation at Month 3
Time frame: from the injection at Month 0 to the evaluation at Month 3, assessed up to 3 months
sleep quality
sleep quality (Spiegel sleep questionnaire ) at 3 months
Time frame: 3 months after the injection
quality of life evaluation
quality of life (SF-36 scale -) at 3 months. a score for each dimension of the SF-36 was calculated, ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain
Time frame: 3 months after the injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.