- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443974
Bracing to Treat Knee Osteoarthritis in Elderly
June 30, 2016 updated by: Christine Brumini, Federal University of São Paulo
Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial
Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population.
Knee braces are often used to prevent common problems in knees during daily activities.
The purpose of these devices is to decrease pain and improve functionality.
In the literature some studies have tested the effectiveness of unloader brace for valgus or varus.
However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature.
There are only few studies on this subject and they are methodologically inadequate.
There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges.
Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA.
Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included.
Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group.
The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months.
Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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 Locations
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SP
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Sao Paulo, SP, Brazil, 04023900
- Federal University of São Paulo
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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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pain in numerical pain scale between 3 and 7cm;
- Knee ligamentous instability
Exclusion Criteria:
- fibromyalgia and neurologic disease;
- knee or hip replacement
- surgery scheduled in the following 6 months
- start physical activity or received joint injection in the past three months
- need to use walking aids or brace in knee
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Knee brace group
Patients received knee brace with hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months
|
|
Experimental: Knee sleeve group
Patients received knee sleeve without hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months
|
|
No Intervention: Control group
Keep medication usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pain measured by a numeric pain scale
Time Frame: Baseline, after 45, 90 and 180 days
|
Baseline, after 45, 90 and 180 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in function measured by Lequesne and WOMAC questionnaires
Time Frame: Baseline, after 45, 90 and 180 days
|
Baseline, after 45, 90 and 180 days
|
Change in quality of life measured by SF-36 questionnaire
Time Frame: Baseline, after 45, 90 and 180 days
|
Baseline, after 45, 90 and 180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
May 13, 2015
First Posted (Estimate)
May 14, 2015
Study Record Updates
Last Update Posted (Estimate)
July 1, 2016
Last Update Submitted That Met QC Criteria
June 30, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP 1248/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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