Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Triamcinolone hexacetonide
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid
Eligibility 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
Sites / Locations
- Universidade Federal de Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Botulinum toxin group
Corticosteroid group
Saline Group
Arm Description
Patients will receive a intervention with joint injection of 100 units of botulinum toxin
Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
Patients will receive a joint injection of 2ml of normal saline
Outcomes
Primary Outcome Measures
Changes on Pain
Evaluated using the visual analogue scale
Secondary Outcome Measures
Changes on Ultrasound parameters
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Changes on quality of life
Evaluated using the Short form 36 questionnaire
Changes on function
Evaluated using the WOMAC questionnaire
Full Information
NCT ID
NCT02829281
First Posted
July 4, 2016
Last Updated
July 7, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02829281
Brief Title
Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
Official Title
Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. 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 %.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin group
Arm Type
Experimental
Arm Description
Patients will receive a intervention with joint injection of 100 units of botulinum toxin
Arm Title
Corticosteroid group
Arm Type
Active Comparator
Arm Description
Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)
Arm Title
Saline Group
Arm Type
Placebo Comparator
Arm Description
Patients will receive a joint injection of 2ml of normal saline
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
Joint injection of Botulinum Toxin Type A
Intervention Type
Drug
Intervention Name(s)
Triamcinolone hexacetonide
Intervention Description
Joint injection of triamcinolone hexacetonide
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Joint injection of Saline
Primary Outcome Measure Information:
Title
Changes on Pain
Description
Evaluated using the visual analogue scale
Time Frame
Baseline, after 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Changes on Ultrasound parameters
Description
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Time Frame
Baseline, after 4, 8 and 12 weeks
Title
Changes on quality of life
Description
Evaluated using the Short form 36 questionnaire
Time Frame
Baseline, after 4, 8 and 12 weeks
Title
Changes on function
Description
Evaluated using the WOMAC questionnaire
Time Frame
Baseline, after 4, 8 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamille G Mendes, MD
Phone
551155764239
Email
jamillegmendes@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rita NV Furtado, MD
Phone
1155764239
Email
rvfurtado@hotmail.com
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
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