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
Key facts
- Who runs it
- Assiut University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 80 people, planned
- Started
- 8 Sept 2025
- Ended
- 31 Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Targeted Exercise Program
- Blood Flow Restriction (BFR) Training with Targeted Exercise Program
- Record updated
- 6 February 2026
Who can take part
- Age
- 30 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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)
Who cannot take part
- History of knee surgery
- History of deep vein thrombosis (DVT)
- Uncontrolled hypertension
- Peripheral vascular disease
- Other significant musculoskeletal or neurological conditions affecting lower extremity function (e.g., hip osteoarthritis, rheumatoid arthritis, peripheral neuropathy)
- BMI > 25
- Any contraindication to exercise or BFR, including:
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Control Group - Targeted Exercise ProgramExisting treatment, for comparison
Participants in the control group will perform a specific targeted exercise program focusing on hip adductors, abductors, internal rotators, and knee extensors. Exercises will be performed at moderate intensity without any blood flow restriction. The program aims to improve lower limb alignment, muscle balance, and functional performance through conventional strengthening exercises.
Treatment: Targeted Exercise Program
- Intervention Group - Blood Flow Restriction (BFR) with Targeted Exercise ProgramTreatment being tested
Participants in the intervention group will perform the same targeted exercise program (hip adductors, abductors, internal rotators, and knee extensors) combined with Blood Flow Restriction (BFR) using a Smart Tools Plus (LLC, USA) pneumatic cuff applied to the proximal thigh. Cuff pressure will be set individually at 40-80% of limb occlusion pressure (LOP), maintained during exercise sets and released during 1-minute rest intervals. The intervention aims to enhance muscle strength and function while minimizing joint stress and pain.
Treatment: Blood Flow Restriction (BFR) Training with Targeted Exercise Program
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 February 2026