Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Triamcinolone hexacetonide; Drug: Botulinum Toxin Type A; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02829281

CEP UNIFESP - 319915

Details and patient eligibility

About

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 %.

Enrollment: 105 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Botulinum toxin group

Experimental group

Description:

Patients will receive a intervention with joint injection of 100 units of botulinum toxin

Treatment:

Drug: Botulinum Toxin Type A

Corticosteroid group

Active Comparator group

Description:

Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)

Treatment:

Drug: Triamcinolone hexacetonide

Saline Group

Placebo Comparator group

Description:

Patients will receive a joint injection of 2ml of normal saline

Treatment:

Drug: Saline