Standardized Traditional Chinese Medicine External Therapy for Chronic Soft Tissue Pain: A Multicenter Observational Study

Abstract

Chronic soft tissue pain has brought a heavy global social and economic burden, while conventional treatments have obvious limitations in efficacy and safety. Traditional Chinese Medicine external therapies (TETs) including cupping, scraping and moxibustion are widely used clinically, yet inconsistent operation standards lead to high research heterogeneity and poor repeatability. This multicenter observational study aimed to evaluate the clinical efficacy, safety, dose-response relationship and cost-effectiveness of standardized TETs for chronic soft tissue pain, and explore the influencing factors of therapeutic effects. A total of 1000 eligible patients from 5 tertiary hospitals across China were divided into three groups: standard TET combined with conventional management (Arm A, n=500), conventional management alone (Arm B, n=300), and high-intensity TET combined with conventional management (Arm C, n=200). All operators received unified training and quantitative operational parameters were adopted to reduce research heterogeneity. Outcome indicators included Numerical Rating Scale (NRS), functional scales, quality of life scales, inflammatory cytokines and neurotrophic factors, with a 24-week observation and 6-month follow-up. Results showed that at the 12th week, the mean NRS reduction of Arm A, B and C was 31.8, 22.0 and 37.9 points respectively. Standardized TETs significantly relieved pain, improved physical function and quality of life, and down-regulated inflammatory factors while up-regulating neurotrophic factors. The weekly treatment frequency of twice was confirmed as the optimal regimen with an obvious ceiling effect in high-frequency intervention. Operation standardization was an independent positive predictor of clinical efficacy. The adverse reactions of TETs were mild and transient, and the intervention had good cost-effectiveness. In conclusion, standardized TETs combined with conventional management is an effective, safe and economically superior regimen for chronic soft tissue pain. The established quantitative standard system effectively solves the problem of poor repeatability of TCM external therapies, which is worthy of clinical popularization and further international research and promotion.