Currently submitted to: JMIR Research Protocols
Date Submitted: Feb 9, 2026
Open Peer Review Period: Feb 10, 2026 - Apr 7, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
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:
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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. Clinical Trial: ITMCTR2025001254. Registered on International Traditional Medicine Clinical Trial Registry, 2025.
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