Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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 %.
Phase:
Phase 4
Details
Lead Sponsor:
Federal University of São Paulo
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Triamcinolone hexacetonide