Effect of Knee Bracing on Improving Pain & Disability

NCT ID: NCT04044612

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-03-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medial Unloader Brace

Group Type: EXPERIMENTAL

Medial Unloader Brace

Intervention Type: OTHER

medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing

Interventions

Medial Unloader Brace

medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Orthotic and Prosthetic Association

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Pietrosimone

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Motion Science Institute

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

18-2363

Identifier Type: -

Identifier Source: org_study_id