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Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02829281
Recruitment Status : Unknown
Verified July 2016 by Jamille Godoy Mendes, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Jamille Godoy Mendes, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE July 4, 2016
First Posted Date  ICMJE July 12, 2016
Last Update Posted Date July 12, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
Changes on Pain [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
Evaluated using the visual analogue scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • 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
  • Changes on quality of life [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
    Evaluated using the Short form 36 questionnaire
  • Changes on function [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
    Evaluated using the WOMAC questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
Official Title  ICMJE Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees
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 %.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Drug: Botulinum Toxin Type A
    Joint injection of Botulinum Toxin Type A
  • Drug: Triamcinolone hexacetonide
    Joint injection of triamcinolone hexacetonide
  • Drug: Saline
    Joint injection of Saline
Study Arms  ICMJE
  • Experimental: Botulinum toxin group
    Patients will receive a intervention with joint injection of 100 units of botulinum toxin
    Intervention: Drug: Botulinum Toxin Type A
  • Active Comparator: Corticosteroid group
    Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
    Intervention: Drug: Triamcinolone hexacetonide
  • Placebo Comparator: Saline Group
    Patients will receive a joint injection of 2ml of normal saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2016)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02829281
Other Study ID Numbers  ICMJE CEP UNIFESP - 319915
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamille Godoy Mendes, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of São Paulo
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP