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Clinical Trials/NCT02443974
NCT02443974
Completed
Phase 4

Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial

Federal University of São Paulo1 site in 1 country120 target enrollmentApril 2015

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Federal University of São Paulo
Enrollment
120
Locations
1
Primary Endpoint
Change in pain measured by a numeric pain scale
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Christine Brumini

MsC

Federal University of São Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in pain measured by a numeric pain scale

Time Frame: Baseline, after 45, 90 and 180 days

Secondary Outcomes

  • Change in function measured by Lequesne and WOMAC questionnaires(Baseline, after 45, 90 and 180 days)
  • Change in quality of life measured by SF-36 questionnaire(Baseline, after 45, 90 and 180 days)

Study Sites (1)

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