Intraspinal versus Extraspinal Acupotomy Decompression, or Their Combination, for Lumbar Disc Herniation: Protocol for a Three-Arm, Randomized, Single-Blind Controlled Trial

Wenlong Yang,1,2 Hailiang Liu,2 Muqing Liu,1 Lei Liu,2 Fangming Liu,2 Zike Dong,1 Xueqi Li1 1School of Acupuncture-Tuina, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, People’s Republic of China; 2Department of Pain Medicine, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Medicine, Jinan, Shandong Province, People’s Republic of ChinaCorrespondence: Wenlong Yang, Department of Pain Medicine, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Medicine, No. 16766 Jingshi Road, Jinan, Shandong Province, 250014, People’s Republic of China, Email [email protected] Fangming Liu, Department of Pain Medicine, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Medicine, No. 16766 Jingshi Road, Jinan, Shandong Province, 250014, People’s Republic of China, Email [email protected]: Acupotomy is a minimally invasive procedure integrating traditional Chinese medicine principles with modern anatomy. While effective for low back pain in lumbar disc herniation (LDH), its efficacy for radicular symptoms from nerve root compression remains limited. A novel technique, intraspinal acupotomy decompression, targets the meningovertebral ligaments (MVL) to alleviate neural compression. This study aims to evaluate and compare the clinical efficacy of intraspinal decompression, extraspinal decompression, and their combination for LDH.Methods: This is a three-arm, randomized, single-center, single-blind (assessor-blinded) controlled trial. Due to the nature of the interventions, participants and practitioners cannot be blinded. The planned sample size is 210 eligible LDH patients aged 20– 85, who will be randomly allocated to one of three groups (n=70 each): the extraspinal acupotomy group, the intraspinal acupotomy group, or the combined group. All groups will receive one treatment session per week for four weeks. The primary outcomes are pain intensity (Visual Analogue Scale, VAS) and lumbar function (Japanese Orthopaedic Association Score, JOA), assessed at baseline, 4 weeks (post-treatment), and 8 weeks (primary endpoint). The secondary outcomes include quality of life (36-Item Short Form Health Survey, SF-36) and adverse events, assessed at 8 weeks.Conclusion: This study will provide high-quality evidence on the efficacy of a novel intraspinal acupotomy technique. The findings will help determine the optimal acupotomy decompression strategy for LDH, potentially offering a more effective minimally invasive option for patients with radicular symptoms.Trial Registration: International Traditional Medicine Clinical Trial Registry (ITMCTR2025001872). Registered on 25 September 2025.Keywords: acupotomy, intraspinal decompression, lumbar disc herniation, randomized controlled trial