Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
NCT ID: NCT02829281
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
105 participants
INTERVENTIONAL
2016-07-31
2016-12-31
Brief Summary
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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 %.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum toxin group
Patients will receive a intervention with joint injection of 100 units of botulinum toxin
Botulinum Toxin Type A
Joint injection of Botulinum Toxin Type A
Corticosteroid group
Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
Triamcinolone hexacetonide
Joint injection of triamcinolone hexacetonide
Saline Group
Patients will receive a joint injection of 2ml of normal saline
Saline
Joint injection of Saline
Interventions
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Botulinum Toxin Type A
Joint injection of Botulinum Toxin Type A
Triamcinolone hexacetonide
Joint injection of triamcinolone hexacetonide
Saline
Joint injection of Saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Jamille Godoy Mendes
MD
Locations
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Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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CEP UNIFESP - 319915
Identifier Type: -
Identifier Source: org_study_id
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