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Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum toxin type A can be useful for treat these patients.
Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus Botulinum toxin type A in the treatment of patients with knee osteoarthritis.
Methods: A prospective controlled randomized double blind studied with three groups (n = 35 each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular medication in a single moment will be undertaken. The three groups will be: Botulinum toxin type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators " blind " in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain, quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures . Will be considered as statistical significance the difference of 5 %.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin group | Experimental | Patients will receive a intervention with joint injection of 100 units of botulinum toxin |
|
| Corticosteroid group | Active Comparator | Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid) |
|
| Saline Group | Placebo Comparator | Patients will receive a joint injection of 2ml of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | Joint injection of Botulinum Toxin Type A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on Pain | Evaluated using the visual analogue scale | Baseline, after 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on Ultrasound parameters | quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler | Baseline, after 4, 8 and 12 weeks |
| Changes on quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamille G Mendes, MD | Contact | 551155764239 | jamillegmendes@gmail.com | |
| Rita NV Furtado, MD | Contact | 1155764239 | rvfurtado@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Sao Paulo | Recruiting | São Paulo | São Paulo | 04023-900 | Brazil |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C005900 | triamcinolone hexacetonide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Triamcinolone hexacetonide |
| Drug |
Joint injection of triamcinolone hexacetonide |
|
| Saline | Drug | Joint injection of Saline |
|
Evaluated using the Short form 36 questionnaire
| Baseline, after 4, 8 and 12 weeks |
| Changes on function | Evaluated using the WOMAC questionnaire | Baseline, after 4, 8 and 12 weeks |
| D012216 |
| Rheumatic Diseases |
| D006867 |
| Hydrolases |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |