Journal of pain research
Efficacy and Safety of Fire-Meridian Stimulation Therapy for Early-Middle Stage Knee Osteoarthritis (Kellgren-Lawrence Grade 0-II): Study Protocol for a Randomized Controlled Trial
By Zhang H, Yuan H, Han M and 5 others.
Abstract
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.