Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829281
• Other study ID #: CEP UNIFESP - 319915
• Status: Recruiting
• Phase: Phase 4
• First received: July 4, 2016
• Last updated: July 7, 2016
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Federal University of São Paulo
• Contact: Jamille G Mendes, MD
• Phone: 551155764239
• Email: jamillegmendes[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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 %.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Botulinum Toxin Type A
Joint injection of Botulinum Toxin Type A
• Triamcinolone hexacetonide
Joint injection of triamcinolone hexacetonide
• Saline
Joint injection of Saline

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on Pain	Evaluated using the visual analogue scale	Baseline, after 4, 8 and 12 weeks	No
Secondary	Changes on Ultrasound parameters	quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler	Baseline, after 4, 8 and 12 weeks	No
Secondary	Changes on quality of life	Evaluated using the Short form 36 questionnaire	Baseline, after 4, 8 and 12 weeks	No
Secondary	Changes on function	Evaluated using the WOMAC questionnaire	Baseline, after 4, 8 and 12 weeks	No