A Phase 4 interventional study of Botulinum Toxin Type A and Triamcinolone hexacetonide in Knee Osteoarthritis, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-12.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
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 %.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's planned enrollment of 105 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Patients will receive a intervention with joint injection of 100 units of botulinum toxin
Drug: Botulinum Toxin Type A
Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
Drug: Triamcinolone hexacetonide
Patients will receive a joint injection of 2ml of normal saline
Drug: Saline
Joint injection of Botulinum Toxin Type A
Joint injection of triamcinolone hexacetonide
Joint injection of Saline
Changes on Pain
Evaluated using the visual analogue scale
Time frame: Baseline, after 4, 8 and 12 weeks
Changes on Ultrasound parameters
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Time frame: Baseline, after 4, 8 and 12 weeks
Changes on quality of life
Evaluated using the Short form 36 questionnaire
Time frame: Baseline, after 4, 8 and 12 weeks
Changes on function
Evaluated using the WOMAC questionnaire
Time frame: Baseline, after 4, 8 and 12 weeks
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo