Clinical trial NCT02829281: Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
Official title: Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
Intra-articular injection
Botulinum Toxin Type A
Corticosteroid
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 105
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 %.


Eligibility criteria: 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

Primary outcomes:
measure: Changes on Pain
timeFrame: Baseline, after 4, 8 and 12 weeks
Secondary outcomes:
measure: Changes on Ultrasound parameters
timeFrame: Baseline, after 4, 8 and 12 weeks
measure: Changes on quality of life
timeFrame: Baseline, after 4, 8 and 12 weeks
measure: Changes on function
timeFrame: Baseline, after 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References: