放射治疗相关神经病理性疼痛（RRNP）是头颈部癌症放疗后最令人不安的并发症之一。药物疗法在剂量调整期和副作用方面存在限制，效果不佳。经皮耳交感神经刺激（taVNS）通过电脉冲刺激耳支交感神经已被证明对某些疾病具有镇痛作用。然而，目前尚不清楚taVNS是否能缓解RRNP。本研究是一项多中心、随机、双盲、平行对照的试验。我们将纳入头颈部癌症放疗后新诊断的成年患者，患有神经病理性疼痛。将招募116名患者，以1：1的比例随机分配接受taVNS或假刺激。干预持续7天，每天两次，每次30分钟。主要疗效结局是第7天的疼痛减轻。次要结局包括功能干扰、心理痛苦、疲劳、生活质量和血清炎症因子的变化。该研究可能为头颈部癌症患者的RRNP提供一种新的早期干预策略。该研究已获得中山大学医学研究伦理委员会的批准（SYSKY-2022-109-01），将严格遵守《赫尔辛基宣言》。所有涉及研究的中心将单独获得伦理批准。研究结果将在同行评审的学术期刊上发表。在合理请求下，研究数据库将由通讯作者提供。NCT05543239.© 作者（或其雇主）2023.根据CC BY-NC许可，可重新使用，但禁止商业再利用。由BMJ出版发表。

Radiotherapy-related neuropathic pain (RRNP) is one of the most distressing complications after radiotherapy for head and neck cancers. Drug therapy is not sufficiently effective and has limitations in terms of dose titration period and side effects. Transcutaneous auricular vagus nerve stimulation (taVNS), which stimulates the auricular branches of the vagus nerve through electrical impulses, has been proven to have analgesic effects in certain diseases. However, it is unknown whether taVNS can relieve RRNP.This is a multicentre, randomised, double-blind, parallel, sham-controlled trial. We will include adult patients newly diagnosed with neuropathic pain after radiotherapy for head and neck cancers. One hundred and sixteen individuals will be recruited and randomly assigned in a 1:1 ratio to receive taVNS or sham stimulation. The interventions will last for 7 days, twice daily for 30 min each. The primary efficacy outcome is pain reduction on day 7. The secondary outcomes are changes in functional interference, psychological distress, fatigue, quality of life and serum inflammatory factors. The study may provide a new early intervention strategy for RRNP among patients with head and neck cancers.This study has been approved by the Medical Research Ethics Committee of Sun Yat-sen University (SYSKY-2022-109-01) and will be conducted in strict accordance with the Declaration of Helsinki. Ethical approvals will be obtained separately for all centres involved in the study. Study results will be published in peer-reviewed academic journals. The database of the study will be available from the corresponding author on reasonable request.NCT05543239.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.