Bracing to Treat Knee Osteoarthritis in Elderly

NCT ID: NCT02443974

Last Updated: 2016-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Knee brace group

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

Group Type: EXPERIMENTAL

Brace (Fisiotensor®)

Intervention Type: DEVICE

Knee sleeve group

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

Group Type: EXPERIMENTAL

Sleeve (Fisiotensor®)

Intervention Type: DEVICE

Control group

Keep medication usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brace (Fisiotensor®)

Intervention Type: DEVICE

Sleeve (Fisiotensor®)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Christine Brumini

MsC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CEP 1248/09

Identifier Type: -

Identifier Source: org_study_id