Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Orthopaedic Research Foundation60 enrolled

Overview

The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Knee Osteoarthritis Arthritis

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is being treated for knee joint pain * Subject is willing and able to comply with the evaluation schedule Exclusion Criteria: * Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures * Subject has current alcohol, opioid, or other drug dependence * Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)

Outcomes

Primary Outcomes

Assessment of Pain Using the Visual Analog Scale

The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.

Time frame: Baseline and 3-month Visit

Secondary Outcomes

Change in Quadriceps Force

Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month.