Efficacy of transcutaneous electrical acupoint stimulation on early mobilisation in patients undergoing unilateral biportal endoscopic discectomy: a study protocol for a randomised controlled trial

经皮穴位电刺激对单侧双通道内镜椎间盘切除术后患者早期活动效果的研究:一项随机对照试验的研究方案

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Abstract

BACKGROUND: Early mobilisation represents a core element of enhanced recovery after surgery (ERAS) and is recommended after minimally invasive spine surgery including unilateral biportal endoscopy (UBE). However, strategies to facilitate early mobilisation after UBE remain limited. Transcutaneous electrical acupoint stimulation (TEAS) may improve postoperative pain and recovery after spine surgery, but available evidence in UBE remains inconclusive. OBJECTIVE: To investigate whether perioperative TEAS enhances postoperative recovery after UBE. METHODS: This single-centre randomised controlled trial with blinded assessors will enrol 114 patients undergoing elective UBE discectomy. Participants will be randomly allocated (1:1) by simple randomisation to receive stimulation via self-adhesive electrodes, either single-session TEAS at Neiguan, Dazhui, Chengshan and Sanyinjiao initiated 30 min before surgery until the end of the procedure using a disperse-dense waveform (2/100 Hz) with individualised intensity (10-15 mA) or sham stimulation applied at four non-meridian, non-acupoint sites with brief initial stimulation followed by 0 mA output. Standardised general anaesthesia with bispectral index and analgesia nociception index monitoring will be provided following ERAS recommendations. The primary outcome is successful ambulation rate at 6 hour postoperatively; baseline pain, nausea, quality of recovery and functional status will be assessed using the Numerical Rating Scale, Visual Analogue Scale, Quality of Recovery-15 questionnaire, Oswestry Disability Index (ODI) and Japanese Orthopaedic Association (JOA) score at baseline before intervention while postoperative pain, nausea and vomiting, opioid consumption and Quality of recovery will be evaluated at 6, 24 and 48 hours after surgery, with ODI and JOA assessed during longer-term follow-up and surgery-related adverse events monitored postoperatively. Continuous outcomes will be analysed using parametric (repeated-measures analysis of variance) or non-parametric (Mann-Whitney U) tests, and categorical variables using χ² or Fisher's exact tests. ETHICAL CONSIDERATIONS AND DISSEMINATION: This study was approved by the Ethics Committee of Beijing Friendship Hospital (No: 2024-P2-087-01) and registered with Chinese Clinical Trial Registry. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2400083344.

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