CHU de Nice
Nice, PACA, 06000, France
NCT Number: NCT04829565
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 4
Nice, PACA, 06000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 months after the injection
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 (functional index evaluation) at 3 months
Time frame: through study completion, an average of 3 months
Collecting adverse events
Time frame: 8 weeks after the injection
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: from the injection at Month 0 to the evaluation at Month 3, assessed up to 3 months
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: 3 months after the injection
sleep quality (Spiegel sleep questionnaire ) at 3 months
Time frame: 3 months after the injection
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
Centre Hospitalier Universitaire de Nice
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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