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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin | Experimental | 50 IU of botulinum toxin |
|
| placebo | Placebo Comparator | 50 IU of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug | echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Dreiser test evaluation | Dreiser test evaluation (functional index evaluation) at 3 months | 3 months after the injection |
| adverse events | Collecting adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Blanc | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | PACA | 06000 | France |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo | Drug | echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo |
|
| 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. | 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 | 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 | 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 | 3 months after the injection |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |