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电针疗法治疗带状疱疹后神经痛患者的疗效:一项多中心、随机、对照、评估者盲法试验的研究方案

Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial.

作者信息

Hu Hantong, Shen Yejing, Li Xinwei, Tian Hongfang, Li XingLing, Li Yang, Cheng Yingying, Wu Lei, Han Dexiong

机构信息

Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.

Department of Acupuncture and Moxibustion, Lishui Hospital of Traditional Chinese Medicine, Lishui, China.

出版信息

Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.

Abstract

The efficacy of conventional treatments for treating postherpetic neuralgia (PHN) remains unsatisfactory. Thus, this multicentre, randomized controlled, assessor-blinded trial aims to investigate the efficacy and safety of electroacupuncture (EA) therapy in patients with PHN. This multicentre randomized controlled trial will enroll 132 patients with PHN from 3 hospitals. All patients will be randomly assigned to either the EA combined with medication group or medication group through a computerized central randomization system in a 1:1 ratio. Outcome measures will be assessed before intervention, at 2, 4, 6 weeks after intervention and at the end of 8-week follow-up. Primary outcomes will be sensory thresholds and pain intensity. Secondary outcomes will include dosage of analgetic, quality of life, anxiety, and depression severity and sleep quality. All adverse effects will be assessed during the trial. This study will provide evidence to ascertain whether EA is effective and safe for treating PHN. Ethics approval (No.ZSLL-KY-2017-025) has been obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Informed consent will be signed prior to subject enrolment. The results will be submitted to international peer-reviewed journals and presented at international conferences. The study protocol has been registered in the clinicaltrials registry with the identification code NCT04594226.

摘要

传统疗法治疗带状疱疹后神经痛(PHN)的疗效仍不尽人意。因此,这项多中心、随机对照、评估者盲法试验旨在探究电针(EA)疗法对PHN患者的疗效和安全性。 这项多中心随机对照试验将从3家医院招募132例PHN患者。所有患者将通过计算机化中央随机系统以1:1的比例随机分配到EA联合药物组或药物组。将在干预前、干预后2周、4周、6周以及8周随访结束时评估结果指标。主要指标将是感觉阈值和疼痛强度。次要指标将包括镇痛药用量、生活质量、焦虑、抑郁严重程度和睡眠质量。试验期间将评估所有不良反应。 本研究将为确定EA治疗PHN是否有效和安全提供证据。 已获得浙江中医药大学附属第三医院伦理委员会的伦理批准(编号:ZSLL-KY-2017-025)。在受试者入组前将签署知情同意书。研究结果将提交给国际同行评审期刊,并在国际会议上发表。 该研究方案已在临床试验注册中心注册,识别码为NCT-04594226。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8bf/8175774/6561152075d1/fmed-08-624797-g0001.jpg

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