Effect of Knee Bracing on Improving Pain & Disability (NCT04044612) | Clinical Trial Compass
CompletedNot Applicable
Effect of Knee Bracing on Improving Pain & Disability
United States31 participantsStarted 2018-12-01
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Change in WOMAC Function score from Baseline to 8 weeks
Timeframe: Baseline, Week 8 (Followup)
2
Percentage Change in Physical Activity Scale for the Elderly from Baseline to 8 weeks
Timeframe: Baseline, Week 8 (Followup)
3
Percentage Change in 30-s chair-stand test from Baseline to 8 weeks
Timeframe: Baseline, Week 8 (Followup)
4
Percentage Change in 20 meter fast-paced walk test from Baseline to 8 weeks
Timeframe: Baseline, Week 8 (Followup)
5
Percentage Change in Stair-climb test from Baseline to 8 weeks
Timeframe: Baseline, Week 8 (Followup)
6
Percentage Change in Femoral Cartilage Cross-sectional area from Baseline to 8 weeks