Five-Step Knee Adjustment Manipulation Based on the ‘Muscle and Bone Balance’ Principle for Treating Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

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Background: Knee osteoarthritis (KOA) is the leading cause of knee joint dysfunction. Manual therapy (MT) can decrease patients' levels of pain and improve their functionality. But most traditional methods focus solely on the knee joint or its surrounding tissues, neglecting the impact of the waist, hip, ankle, and lower limb alignment on KOA. The objective is to clarify the effects of the five-step knee adjustment manipulation on KOA, evaluate its efficacy, and explore new treatment approaches for manual KOA therapy. Methods: (1) 45 healthy volunteers will be recruited to observe the differences in lower limb alignment, quadriceps cross-sectional area, knee joint range of motion (ROM), and gait between healthy individuals and KOA participants. (2) Conduct a multi-center, randomized, single-blind, controlled clinical trial. 120 eligible participants will be included and randomly assigned to a five-step knee adjustment manipulation (FS) group or a sham manipulation (SM) group with a ratio of 1:1. Each group will receive 2 sessions per week applied for 4 weeks and then be followed up for another 8 weeks. The primary outcome is visual analogue scale (VAS). The secondary outcomes include Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, ROM, quadriceps cross-sectional area (CSA), gait analysis, and so on. Conclusion: This technique emphasizes a holistic approach, addressing the lumbar spine, hip, knee, and ankle joints, as well as related muscle groups, to correct lower limb alignment and restore muscle and bone balance. We think it will contribute to providing a promising alternative intervention for middle-aged and older adults with KOA. Trial Registration: The study was approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (Ethics No.: 2024SHL-KY-70-01). Registered in Chinese Clinical Trial Registry (No. ChiCTR2400085536).

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