Efficacy and safety of Zheng’s "Gu cuo feng, jin chu cao" manipulative therapy as an adjunct to percutaneous endoscopic lumbar discectomy for single-level lumbar disc herniation: A multicenter, randomized controlled trial protocol (Preprint)

BACKGROUND Lumbar disc herniation (LDH) is one of the leading causes of low back and leg pain. Although percutaneous endoscopic lumbar discectomy (PELD) is a useful procedure with a minimally invasive surgical procedure, there are patients with persistent pain and functional impairment. Traditional Chinese Medicine (TCM) has a treatment called Tuina, which was found to be effective in conservative management of LDH. The high-quality evidence of its combined use during the perioperative period of PELD is not available. OBJECTIVE The main aim of the trial will be to determine the clinical effectiveness and safety of the Zheng’s "Gu cuo feng, jin chu cao"manipulative therapy when used as the adjunctive to percutaneous endoscopic lumbar discectomy (PELD) of single-level LDH. METHODS The study is a protocol of a randomized controlled superiority trial in a multicenter parallel-group trial to be carried out in 4 Chinese hospitals. There will be 220 eligible patients with single-level LDH randomly assigned by means of 1:1 assignment to the experimental group (it will receive Zheng’s Tuina manipulative therapy before and after the PELD) and to the control group (it will receive PELD only). The main outcome is change in the baseline scores of the Oswestry Disability Index (ODI) score in 3 months after surgery. Visual Analogue Scale (VAS) of the pain, SF-12 health survey, and modified Macnab criteria are classed as the secondary outcomes. The outcome assessors and data analysts will not know the group allocation. RESULTS - CONCLUSIONS The trial will be rigorous in offering evidence concerning the integration of Chinese and Western medicine in the treatment of LDH. This combination methodology might help in achieving functional recovery, better pain management, and creating a new standard of perioperative rehabilitation among this patient group in case it was proven effective. CLINICALTRIAL ITMCTR2025001254. Registered on International Traditional Medicine Clinical Trial Registry, 2025.