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Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Only
Brace Only
Bracing + Exercises
Sponsored by
Orthopaedic Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OrthoIndy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exercise Only

Brace Only

Bracing + Exercises

Arm Description

Home exercise program.

Reaction Web brace.

Reaction Web brace and home exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2015
Last Updated
April 6, 2021
Sponsor
Orthopaedic Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02388646
Brief Title
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedic Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Only
Arm Type
Active Comparator
Arm Description
Home exercise program.
Arm Title
Brace Only
Arm Type
Active Comparator
Arm Description
Reaction Web brace.
Arm Title
Bracing + Exercises
Arm Type
Active Comparator
Arm Description
Reaction Web brace and home exercises.
Intervention Type
Other
Intervention Name(s)
Exercise Only
Intervention Description
This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.
Intervention Type
Device
Intervention Name(s)
Brace Only
Intervention Description
This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
Intervention Type
Other
Intervention Name(s)
Bracing + Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Pain Using the Visual Analog Scale
Description
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 Outcome Measure Information:
Title
Change in Quadriceps Force
Description
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.
Time Frame
Baseline and 3-month Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank R Kolisek, MD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoIndy
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared, only averages and summaries where all participant data is combined.

Learn more about this trial

Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

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