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

NCT07410429 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-14

No results posted yet for this study

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)

Interventions

BEHAVIORAL

Conventional Knee Physical Therapy Program

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.

BEHAVIORAL

Targeted Alignment-Focused Exercise Program for Varus Knee

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-07-30
Completion
2026-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410429 on ClinicalTrials.gov