Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

Study Overview
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Brief Summary
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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 %.

Official Title
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Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Botulinum Toxin Type A
* Drug: Triamcinolone hexacetonide
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 50 years diagnose of knee osteoarthritis using clinics and radiographic criteria pain for more than 6 months analogic visual scale among 4 to 8 patients who agree to sign informed consent Exclusion Criteria: secondary osteoarthritis skin lesion use of intraarticular corticosteroid in the last 3 months use of oral corticosteroid in the last 30 days Kellgren Lawrence I or IV inflammatory arthritis neuromuscular disease use of aminoglycoside antibiotics metalic prosthesis in knee peripheric neuropathy serious cardiovascular or pulmonary disease serious disorder of coagulation pregnancy or breastfeeding infections use of wheelchair

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin group<br>Patients will receive a intervention with joint injection of 100 units of botulinum toxin | Drug: Botulinum Toxin Type A<br>* Joint injection of Botulinum Toxin Type A<br>|
| Active Comparator: Corticosteroid group<br>Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid) | Drug: Triamcinolone hexacetonide<br>* Joint injection of triamcinolone hexacetonide<br>|
| Placebo Comparator: Saline Group<br>Patients will receive a joint injection of 2ml of normal saline | Drug: Saline<br>* Joint injection of Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on Pain | Evaluated using the visual analogue scale | Baseline, after 4, 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid