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

NCT07283237 | Active Not Recruiting

• 1 other identifier: 04-2025-300646
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis (Mild to Moderate, Medial Compartment)

Keywords

Medial knee pain; Varus knee deformity; Blood flow restriction (BFR)

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (OKS)

  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.

  Baseline, 6 weeks (post-intervention), 3 months, and 6 months follow-up.

Secondary Outcomes (3)

• Lower Extremity Functional Scale (LEFS)

  Baseline, 6 weeks, 3 months, and 6 months follow-up.

• Short Form-36 (SF-36) Quality of Life Questionnaire

  Baseline, 6 weeks, 3 months, and 6 months follow-up.

• Numerical Pain Rating Scale (NPRS)

  Baseline, 6 weeks, 3 months, and 6 months follow-up.

Study Arms (2)

Control Group - Targeted Exercise Program

ACTIVE COMPARATOR

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.

Behavioral: Targeted Exercise Program

Intervention Group - Blood Flow Restriction (BFR) with Targeted Exercise Program

EXPERIMENTAL

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.

Device: Blood Flow Restriction (BFR) Training with Targeted Exercise Program

Interventions

Targeted Exercise Program BEHAVIORAL

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.

Control Group - Targeted Exercise Program

Blood Flow Restriction (BFR) Training with Targeted Exercise Program DEVICE

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.

Intervention Group - Blood Flow Restriction (BFR) with Targeted Exercise Program

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Location

Related Publications (7)

• Indications and clinical outcomes of High Tibial Osteotomy: A literature review. Available from: https://meddocsonline.org/journal-of-orthopedics-and-muscular-system/indications-and-clinical-outcomes-of-high-tibial-osteotomy-a-literature-review.html?utm_source=chatgpt.com

  BACKGROUND

• Feucht MJ, Winkler PW, Mehl J, Bode G, Forkel P, Imhoff AB, Lutz PM. Isolated high tibial osteotomy is appropriate in less than two-thirds of varus knees if excessive overcorrection of the medial proximal tibial angle should be avoided. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3299-3309. doi: 10.1007/s00167-020-06166-3. Epub 2020 Jul 20.

  PMID: 32691093 BACKGROUND

• Pipino G, Indelli PF, Tigani D, Maffei G, Vaccarisi D. Opening-wedge high tibial osteotomy: a seven - to twelve-year study. Joints. 2016 Jun 13;4(1):6-11. doi: 10.11138/jts/2016.4.1.006. eCollection 2016 Jan-Mar.

  PMID: 27386441 BACKGROUND

• Elbardesy H, McLeod A, Ghaith HS, Hakeem S, Housden P. Outcomes of double level osteotomy for osteoarthritic knees with severe varus deformity. A systematic review. SICOT J. 2022;8:7. doi: 10.1051/sicotj/2022009. Epub 2022 Apr 1.

  PMID: 35363133 BACKGROUND

• Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.

  PMID: 26872913 BACKGROUND

• Bennell KL, Bowles KA, Wang Y, Cicuttini F, Davies-Tuck M, Hinman RS. Higher dynamic medial knee load predicts greater cartilage loss over 12 months in medial knee osteoarthritis. Ann Rheum Dis. 2011 Oct;70(10):1770-4. doi: 10.1136/ard.2010.147082. Epub 2011 Jul 7.

  PMID: 21742637 BACKGROUND

• Zeng CY, Zhang ZR, Tang ZM, Hua FZ. Benefits and Mechanisms of Exercise Training for Knee Osteoarthritis. Front Physiol. 2021 Dec 16;12:794062. doi: 10.3389/fphys.2021.794062. eCollection 2021.

  PMID: 34975542 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Research Fellow, Assiut University, EGYPT

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)