Effect of Knee Bracing on Improving Pain & Disability

University of North Carolina (UNC)

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Medial Unloader Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT04044612

18-2363

Details and patient eligibility

About

The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.

Enrollment: 31 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants must:

• have a physician diagnosis of knee OA in the medial compartment and exhibit symptomatic knee OA, which the investigators will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction).
• have had a knee radiograph taken within the previous 6 months.
• be between the ages of 40 and 75 years old will be included.

Exclusion criteria

Participants will be excluded if they have:

• been diagnosed with a cardiovascular condition restricting exercise;
• had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks;
• a pacemaker;
• a neurodegenerative condition;
• rheumatoid arthritis;
• cancer;
• neural sensory dysfunction over the knee;
• a BMI over 35;
• history of lower extremity orthopaedic surgery in the past year;
• a history of a traumatic knee injury in the past 6 months;
• any history of a total knee arthroplasty in either extremity; or
• a diagnosed, non-reconstructed knee ligament tear.
• the need of an assistive device to walk.

The investigators will also exclude pregnant women, as well as women who are trying to get pregnant or plan to get pregnant during the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Medial Unloader Brace

Experimental group

Treatment:

Other: Medial Unloader Brace