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脐针联合温针治疗腰椎间盘突出症术后残留麻木的随机对照试验方案

Umbilical acupuncture combined with warm needle acupuncture for the treatment of residual numbness after lumbar disc herniation surgery: a protocol of a randomized controlled trial.

作者信息

Song Kaihua, Cheng Jiayue, Wang Yuming, Shen Yang, Jiang Chenxin, Hong Shouhai

机构信息

The First Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

出版信息

Front Neurol. 2025 Mar 11;16:1528411. doi: 10.3389/fneur.2025.1528411. eCollection 2025.

DOI:10.3389/fneur.2025.1528411
PMID:40134699
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11934960/
Abstract

BACKGROUND

Postoperative residual numbness following lumbar disc herniation (LDH) surgery is a relatively common symptom. Existing drugs and physical therapies are not very effective. Acupuncture is effective for the treatment of LDH, but there are limited reports on its use for postoperative numbness. Based on clinical observations and literature review, we hypothesize that combining umbilical acupuncture (UA) with warm needle acupuncture(WA) may yield superior efficacy compared to electroacupuncture(EA) alone, enhancing immune function, promoting nerve recovery, and improving microcirculation through synergistic effects, thereby filling the gap in this treatment field.

OBJECTIVE

This proposed trial aimed to evaluate the effectiveness and safety of UA (umbilical acupuncture) combined with WA (warm needle acupuncture) in treating residual numbness after LDH surgery. To verify the hypothesis that the combined method is superior to traditional electroacupuncture.

METHODS

This proposed study is a single-center, single-blind, prospective, randomized controlled trial (RCT) involving patients with LDH who were hospitalized and underwent percutaneous endoscopic lumbar discectomy (PELD) at our hospital. Patients meeting the inclusion criteria will be randomly assigned to either the treatment group (umbilical acupuncture combined with warm needle acupuncture) or the control group (electroacupuncture). The participants will be assessed on the first day after surgery, and acupuncture treatment will begin on the second day and continue for three consecutive days, with each session lasting 30 minutes. After that, the treatment mixture was changed three times a week for four weeks. All patients received standard Western medical drug treatment. After the treatment is concluded, a six-month follow-up will be conducted. The primary efficacy indicator will be the visual analog scale (VAS) score for numbness. The secondary efficacy indicators will include the 10 g monofilament test, 40 g pressure acupuncture sensation examination, Japanese Orthopedic Association (JOA) score, lower limb electromyography (H-reflex differences, F-wave conduction velocity, and latency), VAS score, traditional Chinese medicine symptom scoring, and Short Form 36-Health Survey (SF-36) score. Any adverse events occurring during the trial will be recorded. The data will be analyzed according to a predefined statistical analysis plan.

DISCUSSION

This trial combines UA with WA to create a new non-invasive treatment for numbness after LDH surgery, an area where current therapies are inadequate. If proven effective, this combination therapy could offer a safer and more effective alternative to drug treatment, and provide evidence for the integration acupuncture strategies.

CLINICAL TRIAL REGISTRATION

http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2024000328.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/7de5add5516d/fneur-16-1528411-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/562d38f45762/fneur-16-1528411-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/49e26ed796d1/fneur-16-1528411-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/7de5add5516d/fneur-16-1528411-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/562d38f45762/fneur-16-1528411-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/49e26ed796d1/fneur-16-1528411-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/143c/11934960/7de5add5516d/fneur-16-1528411-g003.jpg
摘要

背景

腰椎间盘突出症(LDH)手术后残留麻木是一种较为常见的症状。现有的药物和物理治疗效果不太理想。针灸对LDH的治疗有效,但用于术后麻木的报道有限。基于临床观察和文献回顾,我们推测脐针(UA)联合温针(WA)可能比单纯电针(EA)疗效更佳,通过协同作用增强免疫功能、促进神经恢复并改善微循环,从而填补该治疗领域的空白。

目的

本拟进行的试验旨在评估UA(脐针)联合WA(温针)治疗LDH手术后残留麻木的有效性和安全性。以验证联合方法优于传统电针的假设。

方法

本拟进行的研究是一项单中心、单盲、前瞻性、随机对照试验(RCT),纳入在我院住院并接受经皮内镜下腰椎间盘切除术(PELD)的LDH患者。符合纳入标准的患者将被随机分配至治疗组(脐针联合温针)或对照组(电针)。参与者将在术后第一天进行评估,针灸治疗于第二天开始,连续进行三天,每次治疗持续30分钟。之后,每周更换三次治疗方案,持续四周。所有患者均接受标准的西医药物治疗。治疗结束后,将进行为期六个月的随访。主要疗效指标为麻木的视觉模拟量表(VAS)评分。次要疗效指标将包括10g单丝试验、40g压力针刺感觉检查、日本骨科学会(JOA)评分、下肢肌电图(H反射差异、F波传导速度和潜伏期)、VAS评分、中医症状评分以及简明健康调查量表(SF-36)评分。试验期间发生的任何不良事件都将被记录。数据将根据预先定义的统计分析计划进行分析。

讨论

本试验将UA与WA相结合,为LDH手术后麻木创造了一种新的非侵入性治疗方法,而目前该领域的治疗方法并不充分。如果被证明有效,这种联合疗法可为药物治疗提供更安全、有效的替代方案,并为整合针灸策略提供证据。

临床试验注册

http://itmctr.ccebtcm.org.cn/,标识符ITMCTR2024000328。

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