Clinical trial NCT04044612: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Orthotic and Prosthetic Association
First posted: 2019-08-05
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage Change in WOMAC Function score from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
measure: Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
measure: Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
measure: Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
measure: Percentage Change in Stair-climb test from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
measure: Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks
timeFrame: Baseline, Week 8 (Followup)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Motion Science Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pietrosimone
role: PRINCIPAL_INVESTIGATOR
References: