Effect of Knee Bracing on Improving Pain & Disability

University of North Carolina, Chapel Hill31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage Change in WOMAC Function score from Baseline to 8 weeks

The Western Ontario and McMasters Osteoarthritis Index (WOMAC) is a self-reported measure of disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with a total possible range from 0-68. Higher scores indicate greater amounts of functional limitations.