The Effect of Transcutaneous Electrical Acupuncture Stimulation on Postoperative Pain Control and Mobility in Patients Undergoing Percutaneous Endoscopic Lumbar Discectomy: Study Protocol for a Prospective Randomized Trial

经皮电针刺激对经皮内镜腰椎间盘切除术后患者疼痛控制和活动能力的影响:一项前瞻性随机试验的研究方案

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Abstract

PURPOSE: Optimal perioperative analgesia and early ambulation are critical protocols of enhanced recovery after surgery (ERAS), which significantly impact patients' clinical outcomes in spine surgery. Transcutaneous electrical acupoint stimulation (TEAS), a well-integrated technique combining the meridian-based protocols of conventional needle acupuncture with noninvasive modern electrotherapy, has been widely used to enhance perioperative recovery. Although several studies have confirmed the safety and feasibility of TEAS in various spinal procedures, clinical evidence supporting its application in percutaneous endoscopic lumbar discectomy (PELD) remains limited, prompting surgeons to evaluate its role within spine ERAS protocols. We hypothesized that, compared with placebo acupuncture, TEAS would provide superior pain relief and reduce analgesic requirements during the perioperative period, thereby decreasing opioid-related side effects, facilitating earlier ambulation, and improving short-term postoperative recovery quality after PELD. METHODS: This prospective, single-blind, randomized controlled clinical trial will enroll 86 patients scheduled to undergo PELD. Participants will be randomly assigned (1:1) to an active TEAS group (Group A) or a placebo TEAS group (Group P). In Group A, TEAS is applied bilaterally at Neiguan (PC6), Chengshan (BL57), Sanyinjiao (SP6), and Dachangshu (BL25) using alternating frequencies of 2/100 Hz and intensity ranging from 10 to 15 mA, adjusted to each patient's maximum tolerable level. In Group P, electrodes are placed bilaterally at four non-acupoint sites (located 7 cun and 9 cun above and 1 cun outside HT7, and at 9 cun and 12 cun above BL60) and connected to the stimulator without activating electrical output, maintaining participant blinding. The treatment period includes 30 minutes prior to surgery, continuous stimulation throughout the procedure on the surgery day, and 30-minute interventions each morning on postoperative days 1 and 2 followed by 6 months of follow-up. The primary endpoint is time to postoperative ambulation. Secondary outcomes include pain-related indicators, scores on the 15-item Quality of Recovery scale (QoR-15), gastrointestinal function restoration, adverse events, patient satisfaction, and exploratory assessment of spinal function recovery indicators. DISCUSSION: TEAS offers an alternative for optimal perioperative pain management and promotion of early ambulation, congruent with alleviated ERAS protocols for endoscopic spine surgery. CONCLUSION: This study aims to verify whether TEAS will benefit future patients and contribute to meaningful improvements in ERAS-based perioperative management for micro-spine surgery, ultimately supporting the establishment of a standardized PELD day-surgery model. TRIAL REGISTRATION: The International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/); registered on April 17, 2025. Trial Registration Number: ITMCTR2025000779.

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