Bracing to Treat Knee Osteoarthritis in Elderly

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443974
• Other study ID #: CEP 1248/09
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2015
• Last updated: June 30, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Brace (Fisiotensor®)

• Sleeve (Fisiotensor®)

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain measured by a numeric pain scale		Baseline, after 45, 90 and 180 days	No
Secondary	Change in function measured by Lequesne and WOMAC questionnaires		Baseline, after 45, 90 and 180 days	No
Secondary	Change in quality of life measured by SF-36 questionnaire		Baseline, after 45, 90 and 180 days	No