Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT02829281
- Lead Sponsor
- Federal University of São Paulo
- Brief Summary
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 %.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 105
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Group Saline Patients will receive a joint injection of 2ml of normal saline Botulinum toxin group Botulinum Toxin Type A Patients will receive a intervention with joint injection of 100 units of botulinum toxin Corticosteroid group Triamcinolone hexacetonide Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
- Primary Outcome Measures
Name Time Method Changes on Pain Baseline, after 4, 8 and 12 weeks Evaluated using the visual analogue scale
- Secondary Outcome Measures
Name Time Method Changes on Ultrasound parameters Baseline, after 4, 8 and 12 weeks quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Changes on quality of life Baseline, after 4, 8 and 12 weeks Evaluated using the Short form 36 questionnaire
Changes on function Baseline, after 4, 8 and 12 weeks Evaluated using the WOMAC questionnaire
Trial Locations
- Locations (1)
Universidade Federal de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil