Descompresión por Acupotomía Intrarraquídea versus Extrarraquídea, o su Combinación, para la Hernia Discal Lumbar: Protocolo para un Ensayo Controlado Aleatorizado, a Doble Ciego, de Tres Brazos

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.

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.

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.

International Traditional Medicine Clinical Trial Registry (ITMCTR2025001872). Registered on 25 September 2025.