Bracing to Treat Knee Osteoarthritis in Elderly

NCT02443974 | Completed Phase 4

• 1 other identifier: CEP 1248/09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in pain measured by a numeric pain scale

  Baseline, after 45, 90 and 180 days

Secondary Outcomes (2)

• 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 Arms (3)

Knee brace group

EXPERIMENTAL

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

Device: Brace (Fisiotensor®)

Knee sleeve group

EXPERIMENTAL

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

Device: Sleeve (Fisiotensor®)

Control group

NO INTERVENTION

Keep medication usual

Interventions

Brace (Fisiotensor®) DEVICE

Knee brace group

Sleeve (Fisiotensor®) DEVICE

Knee sleeve group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pain in numerical pain scale between 3 and 7cm;
• Knee ligamentous instability

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Braces

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)