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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes on Pain [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
    Evaluated using the visual analogue scale


Secondary Outcome Measures :
  1. 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

  2. Changes on quality of life [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
    Evaluated using the Short form 36 questionnaire

  3. Changes on function [ Time Frame: Baseline, after 4, 8 and 12 weeks ]
    Evaluated using the WOMAC questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829281


Contacts
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Contact: Jamille G Mendes, MD 551155764239 jamillegmendes@gmail.com
Contact: Rita NV Furtado, MD 1155764239 rvfurtado@hotmail.com

Locations
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Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo

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Responsible Party: Jamille Godoy Mendes, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02829281     History of Changes
Other Study ID Numbers: CEP UNIFESP - 319915
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Jamille Godoy Mendes, Federal University of São Paulo:
knee osteoarthritis
Intra-articular injection
Botulinum Toxin Type A
Corticosteroid
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Triamcinolone diacetate
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Neuromuscular Agents
Peripheral Nervous System Agents