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Bracing to Treat Knee Osteoarthritis in Elderly

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Brace (Fisiotensor®)

Sleeve (Fisiotensor®)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Knee brace group

Knee sleeve group

Control group

Arm Description

Patients received knee brace with hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months

Patients received knee sleeve without hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months

Keep medication usual

Outcomes

Primary Outcome Measures

Change in pain measured by a numeric pain scale

Secondary Outcome Measures

Change in function measured by Lequesne and WOMAC questionnaires

Change in quality of life measured by SF-36 questionnaire

Full Information

NCT ID

NCT02443974

First Posted

April 8, 2015

Last Updated

June 30, 2016

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02443974

Brief Title

Bracing to Treat Knee Osteoarthritis in Elderly

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Knee brace group

Arm Type

Experimental

Arm Description

Patients received knee brace with hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months

Arm Title

Knee sleeve group

Arm Type

Experimental

Arm Description

Patients received knee sleeve without hinges (Fisiotensor®) and were instructed to use it in daily activities, every day, during six months

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Keep medication usual

Intervention Type

Device

Intervention Name(s)

Brace (Fisiotensor®)

Intervention Type

Device

Intervention Name(s)

Sleeve (Fisiotensor®)

Primary Outcome Measure Information:

Title

Change in pain measured by a numeric pain scale

Time Frame

Baseline, after 45, 90 and 180 days

Secondary Outcome Measure Information:

Title

Change in function measured by Lequesne and WOMAC questionnaires

Time Frame

Baseline, after 45, 90 and 180 days

Title

Change in quality of life measured by SF-36 questionnaire

Time Frame

Baseline, after 45, 90 and 180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Federal University of Sao Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

04023900

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Bracing to Treat Knee Osteoarthritis in Elderly

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