Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388646
• Other study ID #: FRKDJO-RWB-15
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2021
• Source: Orthopaedic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

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.

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.

Locations

Country	Name	City	State
United States	OrthoIndy	Greenwood	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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