Knee Arthritis, OsteoarthritisNCT07674901
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
A study testing Knee sleeve in people with Knee Arthritis, Osteoarthritis, run by Margaret L Gourlay, MD, MPH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- What is being tested?
- Knee sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 50-64 years at the time of his/her baseline eligibility screening
- Unilateral or bilateral chronic (≥ 3 months) knee pain
- 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
- English-speaking and able to provide informed consent for study participation
Who cannot join
- History of knee replacement surgery in the painful/affected knee(s)
- Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
- 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
- History of unprovoked falls
- 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)
- Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
Show all 12Show fewer
- Inability to pull on or remove elasticized knee sleeve from affected knee(s)
- 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.
- 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.
- Pregnancy (because of x-ray exposure)
- Cannot attend a 5-year study assessment for follow-up knee radiographs
- Investigator discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RAYUS Radiology
Springfield, Massachusetts, 01107
Margaret L Gourlay, MD, MPH, 413-213-4655, info@kneesleevetrial.org
Margaret L Gourlay, MD, MPH
About this study
Official title: A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
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 baseline, 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
- Conditions
- Knee Arthritis, Osteoarthritis
- Being tested
- Knee sleeve
- Keywords
- Osteoarthritis, Arthritis, Joint, Knee, Osteoarthritis, Knee, Pain, Musculoskeletal
- Medical subject headings
- Osteoarthritis, Arthritis, Osteoarthritis, Knee, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee sleeveDevice
Daily use of one of the following:
- Mueller 4-way Stretch Knee Support
- Mueller FIR Knee Support
- PhysFlex Knee Brace
| Study group | Role | What they receive |
|---|---|---|
| Knee sleeve | Experimental | Daily knee sleeve use Receives: Device: Knee sleeve |
| Control | No intervention | No knee sleeve use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiographic grade of knee osteoarthritis severity
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
Measured: Change from baseline at 5 years
Secondary outcomes (3)
Change in knee pain
Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore
The KOOS pain subscale includes 9 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee function
KOOS activities of daily living subscore
The KOOS activities of daily living function subscale includes 17 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee-related quality of life
KOOS quality of life subscore
The KOOS quality-of-life subscale includes 4 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start21 Oct 2026
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Margaret L Gourlay, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Knee Sleeve Trial Collaborative, LLC
- Responsible party
- Sponsor-investigator, Margaret L Gourlay, MD, MPH, Knee Sleeve Trial Collaborative, LLC
- Investigators
- Margaret L Gourlay, MD, MPH, Principal investigator, Knee Sleeve Trial Collaborative, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674901
- Sponsor's protocol ID
- WCG IRB Study Number 1404409
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
- ClinicalTrials.gov ID
- NCT07674901
- Acronym / sponsor ID
- WCG IRB Study Number 1404409
- Conditions
- Knee Arthritis, Osteoarthritis
- Keywords
- Osteoarthritis, Arthritis, Joint, Knee, Osteoarthritis, Knee, Pain, Musculoskeletal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Margaret L Gourlay, MD, MPHUniversity, hospital or other
- Collaborators
- Knee Sleeve Trial Collaborative, LLC
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 baseline, 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Knee sleeve | Experimental | Device: Knee sleeveDaily knee sleeve use |
| Control | No intervention | –No knee sleeve use |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 50-64 years at the time of his/her baseline eligibility screening
- Unilateral or bilateral chronic (≥ 3 months) knee pain
- 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
- English-speaking and able to provide informed consent for study participation
Key exclusion criteria (12 listed)
- History of knee replacement surgery in the painful/affected knee(s)
- Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
- 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
- History of unprovoked falls
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee sleeveDaily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace | Device | Knee sleeve |
Primary outcome
Change in radiographic grade of knee osteoarthritis severity
Time frame: Change from baseline at 5 years
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
3 secondary outcomes
Change in knee pain
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee function
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee-related quality of life
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret L Gourlay, MD, MPH principal investigator
Knee Sleeve Trial Collaborative, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee sleeve in people with Knee Arthritis, Osteoarthritis, run by Margaret L Gourlay, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret L Gourlay, MD, MPH (413-213-4655, info@kneesleevetrial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radiographic grade of knee osteoarthritis severity (time frame: Change from baseline at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.