Enhancing Medial Knee Pain Rehabilitation : A Clinical Trial On The Effectiveness Of Blood Flow R… (NCT07283237) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Enhancing Medial Knee Pain Rehabilitation : A Clinical Trial On The Effectiveness Of Blood Flow Restriction In Combination With Targeted Exercises For Adult With Varus Deformity
Egypt80 participantsStarted 2025-09-08
Plain-language summary
Medial knee pain is common in active adults with varus knee alignment and can limit daily and sports activities. Standard physiotherapy can reduce pain and improve function, but strength gains may be suboptimal when patients cannot tolerate high loading due to pain. Blood flow restriction (BFR) training allows muscle strength and hypertrophy improvements at low external loads by partially restricting limb blood flow, thereby reducing joint stress. Although BFR has shown benefits in people with knee osteoarthritis, its effectiveness for medial knee pain associated with varus deformity is not well established.
This randomized controlled trial will investigate whether adding BFR to a targeted strengthening program provides superior outcomes compared with the same exercise program alone in active adults with medial knee pain and mild to moderate varus alignment. Approximately 80 participants aged 30-55 years with BMI 18-25, medial knee pain, Kellgren-Lawrence grade 1-3 osteoarthritis, and Hip-Knee-Ankle angle between \>2° and ≤10° varus will be recruited from an outpatient setting. Participants will be randomly assigned (1:1) to either a specific exercise program (hip adductors/abductors, internal rotators, and knee extensors) or the same program performed with BFR using a pneumatic thigh cuff set at 40-80% limb occlusion pressure. Outcomes, including the Oxford Knee Score (primary), lower-extremity function, pain, quality of life, muscle strength, radiographic alignment, and relapse rates over 12 months, will be assessed at baseline and multiple follow-up points by blinded assessors.
Who can participate
Age range
30 Years – 55 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:
* Age between 30 and 55 years
* Body Mass Index (BMI) between 18 and 25
* Presence of medial knee pain
* Mild to moderate varus deformity confirmed via X-Ray Long Film (2° \< HKA ≤ 10°) (4)(4)(5)
* Kellgren and Lawrence classification of osteoarthritis (grades 1-3) (6):
* Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping
* Grade 2 (minimal): definite osteophytes and possible joint space narrowing
* Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone ends
* Active adults (based on REFA work classification)
Exclusion Criteria:
* BMI \> 25
* History of knee surgery
* Any contraindication to exercise or BFR, including:
* History of deep vein thrombosis (DVT)
* Uncontrolled hypertension
* Peripheral vascular disease
* Pregnancy
* Other significant musculoskeletal or neurological conditions affecting lower extremity function (e.g., hip osteoarthritis, rheumatoid arthritis, peripheral neuropathy)
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.