No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 64
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
235 (estimated)
Sponsor
Margaret L Gourlay, MD, MPH · Other
Who this trial is looking for
This trial is looking for older adults with knee pain who want to see if using a knee sleeve every day helps their condition. Participants will use a knee sleeve or not use one, and their progress will be monitored over 5 years.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 50-64 years old.
I have chronic knee pain for at least 3 months.
My knee circumference is between 12 inches and 22 inches.
I can speak English and understand study information.
You may not be able to join if
I have had knee replacement surgery in my painful knee.
I have an upcoming knee surgery scheduled within a year.
I have rheumatoid arthritis or any other inflammatory arthritis.
I have been prescribed a rigid or hinged knee brace.
I cannot remove a knee sleeve from my affected knee.
I have moderate to severe swelling in my knees.
I am currently pregnant.
I cannot attend follow-up visits over 5 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee s…
The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee sleeve versus no knee sleeve use. Participants will have knee radiographs at baseline and year 5 and will complete a survey including Knee injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, knee function and quality of life at 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Aged 50-64 years at the time of his/her baseline eligibility screening
2. Unilateral or bilateral chronic (≥ 3 months) knee pain
3. Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to…
Inclusion Criteria:
1. Aged 50-64 years at the time of his/her baseline eligibility screening
2. Unilateral or bilateral chronic (≥ 3 months) knee pain
3. Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to 28" (71 cm) measured at 4" ABOVE center of knee cap per manufacturers' size specifications for the knee sleeves used in the intervention
4. English-speaking and able to provide informed consent for study participation
Exclusion Criteria:
1. History of knee replacement surgery in the painful/affected knee(s)
2. Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
3. Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint; peripheral arterial disease or other vascular or circulatory disorder; blood clotting disorder; bleeding disorder or self-reported easy bruising; current treatment with an anticoagulant or antiplatelet agent; immobility; nonambulatory status; knee ligament tear or rupture; or lower extremity fracture requiring internal or external fixation within 1 year before study eligibility screening
4. History of unprovoked falls
5. Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s)
6. Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
7. Inability to pull on or remove elasticized knee sleeve from affected knee(s)
8. Kellgren-Lawrence (KL) grade 4 on a baseline standing/weightbearing A/P knee radiograph of the affected knee(s) is excluded because it is the highest KL grade, so a primary outcome event (transition to a higher grade) is impossible.
9. Moderate to severe knee effusion on baseline radiographs of the painful knee(s) is excluded due to the potential risk of harm and discomfort from the compressive effect of a knee sleeve. Individuals with moderate to severe knee effusion during the first screening assessment who are otherwise eligible will be invited to have a repeat A/P knee x-ray 2 months later to reassess radiological eligibility. If the effusion is mild or has resolved by that time, the individual will be invited to enroll in the study.
10. Pregnancy (because of x-ray exposure)
11. Cannot attend a 5-year study assessment for follow-up knee radiographs
12. Investigator discretion
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.