Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT02829281

Collaborator

(none)

105

Enrollment

Location

Arms

Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

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 %.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Botulinum Toxin Type A Drug: Triamcinolone hexacetonide Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin group Patients will receive a intervention with joint injection of 100 units of botulinum toxin	Drug: Botulinum Toxin Type A Joint injection of Botulinum Toxin Type A
Active Comparator: Corticosteroid group Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)	Drug: Triamcinolone hexacetonide Joint injection of triamcinolone hexacetonide
Placebo Comparator: Saline Group Patients will receive a joint injection of 2ml of normal saline	Drug: Saline Joint injection of Saline

Arm

Intervention/Treatment

Experimental: Botulinum toxin group

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

Drug: Botulinum Toxin Type A

Joint injection of Botulinum Toxin Type A

Active Comparator: Corticosteroid group

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

Drug: Triamcinolone hexacetonide

Joint injection of triamcinolone hexacetonide

Placebo Comparator: Saline Group

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

Drug: Saline

Joint injection of Saline

Outcome Measures

Primary Outcome Measures

Changes on Pain [Baseline, after 4, 8 and 12 weeks]
Evaluated using the visual analogue scale

Secondary Outcome Measures

Changes on Ultrasound parameters [Baseline, after 4, 8 and 12 weeks]
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Changes on quality of life [Baseline, after 4, 8 and 12 weeks]
Evaluated using the Short form 36 questionnaire
Changes on function [Baseline, after 4, 8 and 12 weeks]
Evaluated using the WOMAC questionnaire