Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

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 Overview

• Status: Completed
• Conditions: Arthritis; Knee Osteoarthritis
• Intervention / Treatment: Other: Exercise Only; Device: Brace Only; Other: Bracing + Exercises

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • OrthoIndy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orthopaedic Research Foundation
• Investigators: Principal Investigator: Frank R Kolisek, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FRKDJO-RWB-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, only averages and summaries where all participant data is combined.