NCT02829281

Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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 %.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	Joint injection of Botulinum Toxin Type A
DRUG	Triamcinolone hexacetonide	Joint injection of triamcinolone hexacetonide
DRUG	Saline	Joint injection of Saline

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-07-12
• Last updated: 2016-07-12

Locations

1 site across 1 country: Brazil