超声引导下椎旁注射富血小板血浆治疗胸部带状疱疹相关疼痛的研究方案

IF 4.1 2区 医学 Q1 CLINICAL NEUROLOGY Pain and Therapy Pub Date : 2025-02-01 Epub Date: 2024-12-12 DOI:10.1007/s40122-024-00691-6
Liu Wang, Xinyu Lei, Zhixuan Lan, Ruilin He, Zongbin Jiang
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引用次数: 0

摘要

背景:带状疱疹(HZ)由水痘-带状疱疹病毒的再激活引发,表现为带状疱疹相关疼痛(ZAP)的疼痛性皮疹,可发展为带状疱疹后神经痛(PHN)。本研究评估超声引导下椎旁胸椎注射富血小板血浆(PRP)治疗急性ZAP和预防PHN的有效性和安全性。方法:这是一项前瞻性、随机、对照、开放标签、终点盲法、单中心试验,涉及128名带状疱疹相关疼痛患者。参与者将按1:1的比例随机分配到PRP治疗联合抗病毒治疗组或抗病毒治疗组。评估疼痛强度(NRS-11)、生活质量(SF-12)、睡眠质量(PSQI)、疼痛特征、皮肤病变恢复情况、每周抢救镇痛药平均用量和不良事件。在干预后1、3、6、12个月进行随访评估,评估PHN发生率、疼痛强度、生活质量、睡眠质量和安全性。伦理与传播:本研究遵循2013年SPIRIT声明和赫尔辛基宣言,已获得相关委员会的伦理批准。研究结果将通过科学期刊和会议传播,为管理ZAP的全球数据作出贡献。结论:通过比较PRP与抗病毒治疗,本试验旨在建立一种更有效的治疗模式,以减少急性带状疱疹相关疼痛和PHN的发生率,可能为HZ的治疗策略设定新的标准。试验注册:本临床试验已在中国临床试验注册中心(ChiCTR)注册,网址为https://www.chictr.org.cn/index.html(注册号:ChiCTR2400087248,注册日期:2024-07-23)。
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Ultrasound-Guided Thoracic Paravertebral Injection of Platelet-Rich Plasma for the Treatment of Thoracic Herpes Zoster-Related Pain: A Study Protocol.

Background: Herpes zoster (HZ), triggered by the reactivation of the varicella-zoster virus, manifests as a painful rash known as zoster-associated pain (ZAP), which can progress to postherpetic neuralgia (PHN). This study evaluates the efficacy and safety of ultrasound-guided thoracic paravertebral injections of platelet-rich plasma (PRP) in managing acute ZAP and preventing PHN.

Methods: This is a prospective, randomized, controlled, open-label, endpoint-blinded, single-center trial involving 128 participants suffering from zoster-associated pain. Participants will be randomly assigned to the PRP treatment in combination with antiviral therapy group or the antiviral therapy group at a 1:1 ratio. Pain intensity (NRS-11), quality of life (SF-12), sleep quality (PSQI), pain characteristics, skin lesion recovery, average weekly consumption of rescue analgesics, and adverse events will be assessed. Follow-up assessments will be conducted at 1, 3, 6, and 12 months post-intervention to evaluate the incidence rate of PHN, pain intensity, quality of life, sleep quality, and safety.

Ethics and dissemination: Adhering to the 2013 SPIRIT statement and the Declaration of Helsinki, this study has received ethical approval from the relevant committee. Results will be disseminated through scientific journals and conferences, contributing to global data on managing ZAP.

Conclusions: By comparing PRP with antiviral therapy, this trial seeks to establish a more effective treatment paradigm for reducing acute zoster-associated pain and the incidence of PHN, potentially setting a new standard in therapeutic strategies for HZ.

Trial registration: This clinical trial is registered with the Chinese Clinical Trial Registry (ChiCTR) at https://www.chictr.org.cn/index.html (Registration Number: ChiCTR2400087248, Registration Date: 2024-07-23).

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来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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