Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid
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 %.
Interventions
DRUGBotulinum Toxin Type A
Joint injection of Botulinum Toxin Type A
Joint injection of triamcinolone hexacetonide
DRUGSaline
Joint injection of Saline
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Pain | Baseline, after 4, 8 and 12 weeks | Evaluated using the visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactJamille G Mendes, MD
Backup ContactRita NV Furtado, MD
Outcome results
None listed