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

Condition(s) studied

Investigational drug(s) / intervention(s)

Targeted Exercise Program: A structured therapeutic exercise program designed to strengthen the hip adductors, abductors, internal rotators, and knee extensors. The program focuses on improving muscular balance, lower limb alignment, and functional performance in active adults with medial knee pain and varus deformity. Exercises are performed under therapist supervision at moderate intensity without blood flow restriction. This program serves as the control intervention.

Blood Flow Restriction (BFR) Training with Targeted Exercise Program: Participants perform the same targeted exercise program combined with Blood Flow Restriction (BFR) training using a Smart Tools Plus (LLC, USA) pneumatic cuff system applied to the proximal thigh. Cuff pressure is individually set at 40-80% of the limb occlusion pressure (LOP), maintained during exercise sets and released during rest intervals (1 minute between sets). The intervention aims to enhance muscle strength and hypertrophy while reducing joint load and pain, providing an effective rehabilitation approach for adults with medial knee pain and varus deformity.

Study 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.

Eligibility

Primary outcome measure(s)

• Oxford Knee Score (OKS) — Baseline, 6 weeks (post-intervention), 3 months, and 6 months follow-up.
  The Oxford Knee Score (OKS) is a validated 12-item questionnaire designed to assess knee function and pain during daily activities. Each item is scored from 0 to 4, with higher total scores indicating better knee function and reduced pain. It evaluates activities such as walking, climbing stairs, and rising from a chair, reflecting the participant's perceived level of recovery and functional ability.

Trial sites (1)

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