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Updated: Oct 28, 2026
Clinical Efficacy of Tissue-Bone Homeostasis Manipulation on Soft Tissue Balance and Function in Knee Osteoarthritis
Published on: June 16, 2026
Efficacy and Safety of Fire-Meridian Stimulation Therapy for Early-Middle Stage Knee Osteoarthritis
Huifan Zhang1, Haihua Yuan2, Min Han3
1Nursing Department, Shenzhen Pingle Orthopedic Hospital (Shenzhen Pingshan Traditional Chinese Medicine Hospital), Shenzhen, 518122, People's Republic of China.
Background:
Knee osteoarthritis (KOA) is a common degenerative joint disease that often requires prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs), which can cause potential side effects. Fire-Meridian Stimulation Therapy (FMST) is an external traditional Chinese medicine (TCM) therapy using Huolongguan as a specialized instrument, which has been demonstrated to alleviate KOA symptoms. However, high-quality evidence supporting its efficacy and safety remains scarce. This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of FMST for KOA.
Methods:
A total of 72 eligible KOA patients will be randomly assigned to either the FMST group (intervention) or the celecoxib group (control) for six weeks. The primary outcome measure is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes include the Lequesne Index, Visual Analog Scale (VAS) for pain, Hospital for Special Surgery (HSS) knee score, TCM symptom scores, molecular biomarkers (miR-126-3p, COMP, MMP13), and inflammatory markers (CRP, IL-1β, TNF-α). Assessments will be conducted at baseline, post-treatment (six weeks), and twelve-week follow-up. Safety evaluations for FMST will be performed during each treatment session.
Discussion:
This trial will generate robust evidence regarding the clinical value of FMST in managing knee osteoarthritis, potentially offering a safer alternative to prolonged NSAIDs use. By integrating multidimensional outcomes and molecular biomarkers, it may clarify mechanisms driving the therapeutic effects of FMST, thereby linking TCM principles to modern pathophysiological understanding. Findings could enhance non-pharmacological knee osteoarthritis management strategies and guide clinical practice. Limitations, such as single-center design and limited follow-up duration, highlight the need for future multicenter investigations with extended observation periods.
Trial Registration:
International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/), ITMCTR2025000543. Registered on 12March 2025.