Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Conditions
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Knee Osteoarthritis, Arthritis

Intervention / Treatment
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* Other: Exercise Only
* Device: Brace Only
* Other: Bracing + Exercises


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Only<br>Home exercise program. | Other: Exercise Only<br>* This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.<br>|
| Active Comparator: Brace Only<br>Reaction Web brace. | Device: Brace Only<br>* This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.<br>|
| Active Comparator: Bracing + Exercises<br>Reaction Web brace and home exercises. | Other: Bracing + Exercises<br>* This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 3-month Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 3-month Visit |