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Effect of Knee Bracing on Improving Pain & Disability

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medial Unloader Brace
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must:

  • have a physician diagnosis of knee OA in the medial compartment and exhibit symptomatic knee OA, which the investigators will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction).
  • have had a knee radiograph taken within the previous 6 months.
  • be between the ages of 40 and 75 years old will be included.

Exclusion Criteria:

Participants will be excluded if they have:

  • been diagnosed with a cardiovascular condition restricting exercise;
  • had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks;
  • a pacemaker;
  • a neurodegenerative condition;
  • rheumatoid arthritis;
  • cancer;
  • neural sensory dysfunction over the knee;
  • a BMI over 35;
  • history of lower extremity orthopaedic surgery in the past year;
  • a history of a traumatic knee injury in the past 6 months;
  • any history of a total knee arthroplasty in either extremity; or
  • a diagnosed, non-reconstructed knee ligament tear.
  • the need of an assistive device to walk.

The investigators will also exclude pregnant women, as well as women who are trying to get pregnant or plan to get pregnant during the study.

Sites / Locations

  • Motion Science Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medial Unloader Brace

Arm Description

Outcomes

Primary Outcome Measures

Percentage Change in WOMAC Function score from Baseline to 8 weeks
The Western Ontario and McMasters Osteoarthritis Index (WOMAC) is a self-reported measure of disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with a total possible range from 0-68. Higher scores indicate greater amounts of functional limitations.
Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity
Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
The number of times that an individual can sit and stand in 30 seconds.
Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
The investigators will time the amount of seconds it takes to walk 20 meters.
Percentage Change in Stair-climb test from Baseline to 8 weeks
The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.
Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks
The investigators will measure the amount of cartilage cross-sectional area on the anterior femur before and after 3000 steps of walking. A greater change in cross-sectional area is determined to be more more cartilage deformation.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2019
Last Updated
March 5, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Orthotic and Prosthetic Association
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1. Study Identification

Unique Protocol Identification Number
NCT04044612
Brief Title
Effect of Knee Bracing on Improving Pain & Disability
Official Title
Effect of Knee Bracing on Improving Pain & Disability, Physical Performance, Physical Activity and Femoral Cartilage Deformation in Individuals With Medial Compartment Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Orthotic and Prosthetic Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medial Unloader Brace
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Medial Unloader Brace
Intervention Description
medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing
Primary Outcome Measure Information:
Title
Percentage Change in WOMAC Function score from Baseline to 8 weeks
Description
The Western Ontario and McMasters Osteoarthritis Index (WOMAC) is a self-reported measure of disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with a total possible range from 0-68. Higher scores indicate greater amounts of functional limitations.
Time Frame
Baseline, Week 8 (Followup)
Title
Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
Description
Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity
Time Frame
Baseline, Week 8 (Followup)
Title
Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
Description
The number of times that an individual can sit and stand in 30 seconds.
Time Frame
Baseline, Week 8 (Followup)
Title
Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
Description
The investigators will time the amount of seconds it takes to walk 20 meters.
Time Frame
Baseline, Week 8 (Followup)
Title
Percentage Change in Stair-climb test from Baseline to 8 weeks
Description
The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.
Time Frame
Baseline, Week 8 (Followup)
Title
Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks
Description
The investigators will measure the amount of cartilage cross-sectional area on the anterior femur before and after 3000 steps of walking. A greater change in cross-sectional area is determined to be more more cartilage deformation.
Time Frame
Baseline, Week 8 (Followup)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must: have a physician diagnosis of knee OA in the medial compartment and exhibit symptomatic knee OA, which the investigators will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction). have had a knee radiograph taken within the previous 6 months. be between the ages of 40 and 75 years old will be included. Exclusion Criteria: Participants will be excluded if they have: been diagnosed with a cardiovascular condition restricting exercise; had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 2 weeks; a pacemaker; a neurodegenerative condition; rheumatoid arthritis; cancer; neural sensory dysfunction over the knee; a BMI over 35; history of lower extremity orthopaedic surgery in the past year; a history of a traumatic knee injury in the past 6 months; any history of a total knee arthroplasty in either extremity; or a diagnosed, non-reconstructed knee ligament tear. the need of an assistive device to walk. The investigators will also exclude pregnant women, as well as women who are trying to get pregnant or plan to get pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Pietrosimone
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Science Institute
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Investigator who proposes to use the data has IRB, IEC, or REB approval and executed a data use/sharing agreement with UNC.

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Effect of Knee Bracing on Improving Pain & Disability

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