Targeted Rehabilitation Versus Standard Care in Managing Medial Knee Pain and Varus Malalignment: A Randomized Control Trial

NCT07410429 | Active Not Recruiting

• 1 other identifier: 04-2025-300620
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Medial knee pain with varus alignment is common in active adults and is associated with increased medial joint loading, cartilage loss, and progression of knee osteoarthritis. Conventional rehabilitation typically emphasizes quadriceps strengthening and general physiotherapy, which may reduce pain and improve function but often has limited effect on abnormal frontal-plane loading and alignment in individuals with varus deformity. Targeted neuromuscular and alignment-focused exercise programs that emphasize hip and lower-limb muscle control may better address underlying biomechanical contributors to medial knee loading. This randomized controlled trial will compare a traditional/conventional physical therapy program with a specific, alignment-focused exercise program in active adults aged 30-55 years who have medial knee pain, mild to moderate varus deformity, and Kellgren-Lawrence grade 1-3 knee osteoarthritis. Approximately 80 participants will be recruited from an outpatient setting and randomized (1:1) to receive either traditional rehabilitation or a targeted exercise protocol focusing on hip adductors and internal rotators. The supervised intervention will last 6 weeks, with follow-up assessments at 12 weeks, 6 months, and 1 year. The primary outcome is the Oxford Knee Score, with secondary outcomes including lower-extremity function, pain, quality of life, muscle strength, and radiographic alignment.

Conditions

Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3)

Keywords

Medial knee pain; Varus knee alignment; Knee osteoarthritis; Alignment-focused exercise

Outcome Measures

Primary Outcomes (1)

• Change in Oxford Knee Score (OKS)

  OKS is a 12-item patient-reported outcome measure assessing knee pain and function; total score range 0-48 (higher scores indicate better status)

  Baseline, 6 weeks, 3 months, and 6 months

Secondary Outcomes (10)

• Kellgren-Lawrence (K-L) Radiographic Grade

  Baseline, 6 weeks, 3 months, 6 months

• Lower Extremity Functional Scale (LEFS)

  Baseline, 6 weeks, 3 months, 6 months

• Numeric Pain Rating Scale (NPRS)

  Baseline, 6 weeks, 3 months, 6 months

• SF-36 Health-Related Quality of Life

  Baseline, 6 weeks, 3 months, 6 months

• Hip Muscle Strength (MMT)

  Baseline and 6 weeks

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

Participants receive a conventional outpatient physical therapy program for medial knee pain and varus knee osteoarthritis. The program typically includes: * Quadriceps and general lower-extremity strengthening * Range-of-motion and flexibility exercises * Functional and gait training * Other standard modalities or manual techniques as per clinic routine Frequency and duration: supervised sessions over a 6-week period, with a home exercise component

Behavioral: Conventional Knee Physical Therapy Program

Targeted Exercise Program

EXPERIMENTAL

Participants receive a specific exercise protocol focused on: * Strengthening hip adductors and internal rotators * Lower-limb strength and neuromuscular control aimed at improving dynamic alignment and reducing medial knee load * Progressive closed- and open-chain exercises tailored to varus alignment The program is delivered over 6 weeks in supervised outpatient sessions with a structured home program.

Behavioral: Targeted Alignment-Focused Exercise Program for Varus Knee

Interventions

Conventional Knee Physical Therapy Program BEHAVIORAL

Participants receive a conventional outpatient physical therapy program for medial knee pain and early medial compartment osteoarthritis. Treatment typically includes quadriceps and general lower-limb strengthening, range-of-motion and flexibility exercises, gait and functional training, and manual therapy or modalities as needed according to usual clinic practice. The program is delivered over 6 weeks in supervised sessions, with a standardized home exercise program provided to reinforce clinic-based treatment.

Traditional Physical Therapy

Targeted Alignment-Focused Exercise Program for Varus Knee BEHAVIORAL

Participants receive a structured 6-week exercise program specifically designed to improve dynamic alignment and frontal-plane control in individuals with varus knee alignment. The program emphasizes strengthening of the hip adductors, abductors, and internal rotators, as well as knee extensors, using a combination of open- and closed-chain exercises and neuromuscular training during functional tasks (such as squatting, stepping, and gait-related activities). Exercise intensity and complexity are progressively increased based on tolerance and performance, and a complementary home exercise program is prescribed to support carryover between supervised sessions.

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 30-55 years
• BMI 18-25 kg/m²
• Presence of medial knee pain
• Mild to moderate varus deformity confirmed via long-leg X-ray (e.g., 2° \< Hip-Knee-Ankle angle ≤ 10°)
• Kellgren-Lawrence grade 1-3 knee osteoarthritis
• Active adults based on REFA work classification
• Able and willing to complete a 6-week exercise program and follow-up visits
• Provision of written informed consent

You may not qualify if:

• BMI \> 25 kg/m²
• History of knee surgery on the affected side
• Any contraindication to exercise (e.g., unstable cardiovascular conditions)
• 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 (9)

• Tarassoli P, Wood JA, Chen DB, Griffiths-Jones W, Bellemans J, MacDessi SJ. Arithmetic hip-knee-ankle angle and stressed hip-knee-ankle angle: equivalent methods for estimating constitutional lower limb alignment in kinematically aligned total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Sep;30(9):2980-2990. doi: 10.1007/s00167-022-07038-8. Epub 2022 Jul 11.

  PMID: 35819463 BACKGROUND

• Na YG, Lee BK, Choi JU, Lee BH, Sim JA. Change of joint-line convergence angle should be considered for accurate alignment correction in high tibial osteotomy. Knee Surg Relat Res. 2021 Jan 11;33(1):4. doi: 10.1186/s43019-020-00076-x.

  PMID: 33431062 BACKGROUND

• Sheehy L, Felson D, Zhang Y, Niu J, Lam YM, Segal N, Lynch J, Cooke TD. Does measurement of the anatomic axis consistently predict hip-knee-ankle angle (HKA) for knee alignment studies in osteoarthritis? Analysis of long limb radiographs from the multicenter osteoarthritis (MOST) study. Osteoarthritis Cartilage. 2011 Jan;19(1):58-64. doi: 10.1016/j.joca.2010.09.011. Epub 2010 Oct 13.

  PMID: 20950695 BACKGROUND

• Koike, M., Nose, H., Takagi, S., Akimoto, A., & Kaji, T. (2015). A skyline-view imaging technique for axial projection of the patella: a clinical study. Radiological Physics and Technology 2014 8:2, 8(2), 174-177. https://doi.org/10.1007/s12194-014-0305-y

  BACKGROUND

• Puls L, Hauke D, Camathias C, Hugle T, Barg A, Valderrabano V. Conservative Trio-Therapy for Varus Knee Osteoarthritis: A Prospective Case-Study. Medicina (Kaunas). 2022 Mar 22;58(4):460. doi: 10.3390/medicina58040460.

  PMID: 35454299 BACKGROUND

• Moon HH, Seo YG, Kim WM, Yu JH, Lee HL, Park YJ. Effect of Combined Exercise Program on Lower Extremity Alignment and Knee Pain in Patients with Genu Varum. Healthcare (Basel). 2022 Dec 30;11(1):122. doi: 10.3390/healthcare11010122.

  PMID: 36611582 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

• Romanenko K, Karpinska O, Prozorovsky D. [THE INFLUENCE OF VARUS DEFORMITY ATMIDDLE THIRD OF FEMURON THE STRENGTH OF THE LOWER LIMB MUSCLES]. Georgian Med News. 2021 Dec;(321):102-111. Russian.

  PMID: 35000917 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, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: February 8, 2026
• First Posted: February 13, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)