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经皮耳迷走神经刺激治疗头颈部癌症放射性神经病理性疼痛的疗效(RELAX):一项多中心、随机、双盲、假刺激对照试验的方案。

Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial.

机构信息

Department of Neurology, Sun Yat-sen Memorial Hospital, Guangzhou, China.

Division of Clinical Research Design, Sun Yat-sen University, Guangzhou, China.

出版信息

BMJ Open. 2023 Sep 20;13(9):e072724. doi: 10.1136/bmjopen-2023-072724.


DOI:10.1136/bmjopen-2023-072724
PMID:37730386
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10514600/
Abstract

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT05543239.

摘要

简介:放射性治疗相关神经性疼痛(RRNP)是头颈部癌症放射治疗后最痛苦的并发症之一。药物治疗效果并不充分,并且在剂量调整期和副作用方面存在局限性。经皮耳迷走神经刺激(taVNS)通过电脉冲刺激迷走神经的耳支,已被证明在某些疾病中具有镇痛作用。然而,尚不清楚 taVNS 是否可以缓解 RRNP。

方法和分析:这是一项多中心、随机、双盲、平行、假刺激对照试验。我们将纳入新诊断为头颈部癌症放射治疗后神经性疼痛的成年患者。将招募 116 名患者,并以 1:1 的比例随机分配接受 taVNS 或假刺激。干预将持续 7 天,每天两次,每次 30 分钟。主要疗效结局是第 7 天疼痛减轻。次要结局是功能障碍、心理困扰、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。

伦理和传播:本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),并将严格按照赫尔辛基宣言进行。将分别为参与研究的所有中心获得伦理批准。研究结果将发表在同行评议的学术期刊上。研究数据库将根据合理要求由通讯作者提供。

试验注册号:NCT05543239。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/10514600/37c58bc83c9c/bmjopen-2023-072724f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/10514600/c849dde4c2a0/bmjopen-2023-072724f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/10514600/37c58bc83c9c/bmjopen-2023-072724f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/10514600/c849dde4c2a0/bmjopen-2023-072724f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/10514600/37c58bc83c9c/bmjopen-2023-072724f02.jpg

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[2]
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[3]
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本文引用的文献

[1]
TNFα in MS and Its Animal Models: Implications for Chronic Pain in the Disease.

Front Neurol. 2021-12-6

[2]
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[3]
Role of IL-6 in the regulation of neuronal development, survival and function.

Cytokine. 2021-8

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Front Hum Neurosci. 2021-3-23

[5]
Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial.

Ann Rheum Dis. 2021-2

[6]
HPLC-DAD-UV analysis, anti-inflammatory and anti-neuropathic effects of methanolic extract of Sideritis bilgeriana (lamiaceae) by NF-κB, TNF-α, IL-1β and IL-6 involvement.

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Pain Med. 2021-2-4

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Cephalalgia. 2019-9-15

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J Clin Oncol. 2018-11-20

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Brain Stimul. 2018-8-23

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