Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

July 7, 2016 updated by: Jamille Godoy Mendes, Federal University of São Paulo

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

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 %.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Recruiting
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on Pain
Time Frame: Baseline, after 4, 8 and 12 weeks
Evaluated using the visual analogue scale
Baseline, after 4, 8 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on Ultrasound parameters
Time Frame: Baseline, after 4, 8 and 12 weeks
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Baseline, after 4, 8 and 12 weeks
Changes on quality of life
Time Frame: Baseline, after 4, 8 and 12 weeks
Evaluated using the Short form 36 questionnaire
Baseline, after 4, 8 and 12 weeks
Changes on function
Time Frame: Baseline, after 4, 8 and 12 weeks
Evaluated using the WOMAC questionnaire
Baseline, after 4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP UNIFESP - 319915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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