Clinical efficacy of a Chinese herbal gel plaster combined with manipulation for lumbar disc herniation: a prospective, randomized, double-blind, placebo-controlled trial

Tianhao Wan¹GEZHI ZHANG²Haibao Wen¹Lifeng Zhuang¹Haotian Yang¹Di Xia¹Chao Su¹Jinqiao Zou¹Fajie Li¹Jinyu Gu³Qing Zhang^1*

• ¹Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, China
• ²China Academy of Chinese Medical Sciences, Beijing, China
• ³China Academy of Chinese Medical Sciences Xiyuan Hospital, Beijing, China

Background: Haitongpi Formula, derived from the Traditional Chinese Medicine (TCM) classic Yizong Jinjian, has shown efficacy for low back pain, fractures, and osteoarthritis. Haitongpi Formula Gel Paste (HTPGP) is a modern dosage form of this formula, but clinical evidence on its effectiveness and safety remains limited. This study was designed to evaluate the clinical efficacy and safety of HTPGP combined with manipulation in relieving chronic pain caused by lumbar disc herniation (LDH). Methods: Adults aged 40–60 years with LDH were randomly assigned to receive Qing dynasty three-movement manipulation plus HTPGP or placebo plaster (PLAGP) for 2 weeks, with 4 weeks of follow-up. The primary outcome was pain intensity measured by the visual analog scale (VAS); secondary outcomes included the Oswestry Disability Index (ODI) and surface electromyography (sEMG). Analyses were performed using generalized estimating equations, repeated-measures ANOVA, and Mann–Whitney U tests. Results: Between October 2024 and June 2025, 100 eligible participants were randomized (HTPGP vs. PLAGP, 1:1). The HTPGP group demonstrated significantly greater VAS improvement from day 7 onwards (Z = 2.644–4.332). ODI scores were consistently lower in the HTPGP group (main effect F = 33.43; time effect F = 227.21; interaction F = 17.19). No significant between-group differences were observed in sEMG outcomes, and no serious adverse events occurred. Conclusion: In patients with LDH, HTPGP combined with manipulation provided greater pain reduction and better functional improvement than those observed in the placebo group, with a favorable safety profile. Larger randomized trials are required to confirm these findings. Trial registration: The trial was registered with the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/; No. ITMCTR2024000077).