235 Participants NeededMy employer runs this trial

Knee Sleeve for Knee Arthritis

ML
Overseen ByMargaret L Gourlay, MD, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether wearing a knee sleeve daily can slow the progression of knee arthritis and improve knee pain and function over five years. Participants will split into two groups: one will wear the knee sleeve, and the other will not. The trial aims to determine if the sleeve alleviates symptoms like pain and difficulty with daily activities. Individuals with chronic knee pain for at least three months who have not used a knee sleeve for more than six months may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance knee arthritis management.

What prior data suggests that this knee sleeve is safe for knee arthritis?

Research has shown that knee sleeves are generally safe for people with knee pain. Made from stretchy fabric, these sleeves gently squeeze and support the knee. Without involving surgery or medication, they present a low risk of side effects.

Users report that knee sleeves are comfortable and have not experienced any serious problems. Some might feel mild skin irritation or discomfort, but these issues are usually manageable and not serious.

Overall, knee sleeves are considered a safe option for managing ongoing knee pain.

Why are researchers excited about this trial?

Unlike standard treatments for knee arthritis, which often include medications like NSAIDs or physical therapy, the knee sleeve offers a non-invasive, drug-free approach to managing symptoms. This treatment is unique because it provides support and compression to the knee joint, potentially reducing pain and improving mobility without the side effects associated with medication. Researchers are excited about this option because it could offer a simple, cost-effective solution for arthritis sufferers, enhancing quality of life with minimal risk.

What evidence suggests that this knee sleeve is effective for knee arthritis?

This trial will compare the use of a knee sleeve with no intervention for knee arthritis. Studies have shown that knee sleeves can significantly benefit people with knee osteoarthritis. In one study, 54% of users reported less pain, and 62% found daily activities easier. Another study found that wearing a simple elastic knee sleeve immediately improved movement and reduced pain. This type of knee support primarily enhances the body's awareness of movement and position. Overall, knee sleeves have received high ratings for reducing stiffness and improving quality of life for those with knee problems.12345

Who Is on the Research Team?

ML

Margaret L Gourlay, MD, MPH

Principal Investigator

Knee Sleeve Trial Collaborative, LLC

Are You a Good Fit for This Trial?

This trial is for adults aged 50-64 who have had knee pain from arthritis or osteoarthritis for at least 3 months. People with other major health issues or recent knee surgery may not be eligible.

Inclusion Criteria

My knee or thigh size fits within the required range for the knee sleeve.
English-speaking and able to provide informed consent for study participation
I have had knee pain in one or both knees for at least 3 months.
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Exclusion Criteria

I have a torn or ruptured knee ligament.
Kellgren-Lawrence (KL) grade 4 on baseline standing/weightbearing A/P knee radiograph of affected knee(s)
Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for affected knee(s)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to daily use of an elasticized fabric knee sleeve or no knee sleeve use

5 years
Annual visits for assessments

Interim Analysis

A prespecified interim analysis of the 1-year KOOS subscore data will be performed

1 year
1 visit (in-person)

Follow-up

Participants are monitored for knee osteoarthritis progression and knee-related symptoms

5 years
Annual visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Knee sleeve

Trial Overview

The study compares daily use of an elastic knee sleeve to no sleeve in older adults with chronic knee pain, to see if the sleeve helps slow joint damage and improve symptoms over five years. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Knee sleeveExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Margaret L Gourlay, MD, MPH

Lead Sponsor

Knee Sleeve Trial Collaborative, LLC

Collaborator

Citations

EFFECTS OF A SEMI-RIGID KNEE BRACE ON MOBILITY ...

54% of respondents reported a reduction in pain symptoms and 62% of respondents reported an improvement in overall daily functioning while ...

Effectiveness, safety, and cost–utility of a knee brace in ...

The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL

What Science ACTUALLY Says About Knee Supports & Braces ...

Which knee support or knee brace will help reduce your arthritis pain? In this video, I discuss the benefits and limitations of different ...

A network meta-analysis based on randomized clinical trials

Knee brace ranked highest in effectiveness concerning the WOMAC stiffness score, followed by exercise and hydrotherapy. For the total WOMAC ...

Knee braces for knee osteoarthritis: A scoping review and ...

Sleeve braces were predominantly proposed to have neuromuscular mechanisms of action (particularly increased proprioception and improved muscle function/ motor ...