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A study of the effects of evidence-based mild moxibustion therapy on health-related quality of life in patients with diabetic peripheral neuropathy

注册号：

Registration number：

ITMCTR2025001160

最近更新日期：

Date of Last Refreshed on：

2025-06-12

注册时间：

Date of Registration：

2025-06-12

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于循证的温和灸对糖尿病周围神经病变患者健康相关生活质量的影响研究

Public title：

A study of the effects of evidence-based mild moxibustion therapy on health-related quality of life in patients with diabetic peripheral neuropathy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于循证的温和灸对糖尿病周围神经病变患者健康相关生活质量的影响研究

Scientific title：

A study of the effects of evidence-based mild moxibustion therapy on health-related quality of life in patients with diabetic peripheral neuropathy

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

徐天慧

研究负责人：

王琴

Applicant：

Xutianhui

Study leader：

Wangqin

申请注册联系人电话：

Applicant telephone：

15273199193

研究负责人电话：

Study leader's telephone：

18774806226

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

403174653@qq.com

研究负责人电子邮件：

Study leader's E-mail：

wangqin3421@csu.edu.cn

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

湖南省长沙市岳麓区桐梓坡路172号

研究负责人通讯地址：

湖南省长沙市芙蓉区人民中路139号

Applicant address：

No. 172 Tongzipo Road Yuelu District Changsha City Hunan Province China

Study leader's address：

No. 139 Middle Renmin RoadChangsha Hunan

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅护理学院

Applicant's institution：

Xiangya Nursing School of Central South University

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

E202536

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中南大学湘雅护理学院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Xiangya School of Nursing Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

2025/5/8 0:00:00

伦理委员会联系人：

杨敏

Contact Name of the ethic committee：

Huangmin

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路172号

Contact Address of the ethic committee：

No. 172 Tongzipo Road Yuelu District Changsha City Hunan Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

18073185501

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yangminzhu@csu.edu.cn

研究实施负责（组长）单位：

中南大学湘雅二医院

Primary sponsor：

The Second Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

中南大学湘雅二医院

Primary sponsor's address：

The Second Xiangya Hospital of Central South University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅二医院

具体地址：

湖南省长沙市芙蓉区人民中路139号

Institution
hospital：

The Second Xiangya Hospital of Central South University

Address：

No. 139 Middle Renmin RoadChangsha Hunan

国家：

中国

省(直辖市)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅护理学院

具体地址：

湖南省长沙市岳麓区桐梓坡路172号

Institution
hospital：

Xiangya Nursing School of Central South University

Address：

No. 172 Tongzipo Road Yuelu District Changsha City Hunan Province China

经费或物资来源：

中南大学湘雅二医院

Source(s) of funding：

The Second Xiangya Hospital of Central South University

研究疾病：

糖尿病周围神经病变

研究疾病代码：

Target disease：

Diabetic peripheral neuropathy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

本研究基于循证系统整合现有温和灸治疗糖尿病周围神经病变的临床证据，构建标准化的温和灸干预方案。通过量性评估的方式，重点分析温和灸对DPN患者健康相关生活质量的影响，为临床实践提供兼具科学性和实用性的非药物干预方案。

Objectives of Study：

This study systematically synthesizes existing clinical evidence on moxibustion therapy for diabetic peripheral neuropathy (DPN) based on an evidence-based approach aiming to establish a standardized moxibustion intervention protocol. Through quantitative evaluation it focuses on analyzing the impact of moxibustion on health-related quality of life (HRQoL) in DPN patients thereby providing a scientifically rigorous and clinically practical non-pharmacological intervention for healthcare practice.

药物成份或治疗方案详述：

在常规护理的基础上，加之循证艾灸干预。 1.辨证分型：在实施温和灸前，由中医科主治医师对患者进行辨证论治分型，确保艾灸治疗与个体证型相匹配。 2.取穴处方：以脾俞（BL20）、肾俞（BL23）、足三里（ST36）、三阴交（SP6）为核心穴位，结合上下肢及腹背部的配穴，整体调理脾胃、肾气及经络气血，兼顾局部症状的辩证施治。 气虚血瘀证配以关元（CV4）、气海（CV6）、膈俞（BL17）；阳虚寒凝证配以大椎（GV14）、命门（GV4）、关元（CV4）；痰瘀阻络证配以丰隆（ST40）、血海（SP10）、膈俞（BL17）；肝肾亏虚配以肝俞（BL18）、太溪（KI3）。 上肢麻木、疼痛者加灸曲池（LI11）、外关（TE5）、合谷（LI4）压指，下肢麻木、疼痛较甚者加灸太溪（KI3）、阳陵泉（GB34）、涌泉（KI1），下肢萎缩者加灸悬钟（GB39）、伏兔(ST32）。 3.腧穴定位：严格参照《腧穴名称与定位》(GB/T12346-2006)国家标准执行。 4.操作方法 ①温和灸方法：取标准清艾条一支，点燃端距皮肤3-5cm，以患者自觉温热舒适为度。对感觉障碍者，术者需以食、中二指分置灸点两侧监测温度，每5分钟调整一次灸距，至皮肤微红即止。有条件者加予温度仪检测皮肤温度，控制在41-43℃，防止烫伤。 ②温盒灸方法：将灸盒安放于施灸部位的中央，灸盒内置点燃的艾段（距铁纱网2-3cm），通过盒盖开合调节温度，维持温热舒适、无灼痛感。每10分钟检查皮肤反应，以皮肤稍有红晕为度。灸毕先开盖散热5分钟再移盒，艾灰须完全熄灭处理。 5.时间与疗程：施灸时间控制在10-20分钟/穴，单次总时长不超过40分钟。6次为一个疗程，共艾灸2个疗程，疗程间隔1天。

Description for medicine or protocol of treatment in detail：

1.Syndrome Differentiation and Typing: Before implementing mild moxibustion the attending physician from the Department of Traditional Chinese Medicine (TCM) will conduct syndrome differentiation and typing for the patient to ensure that the moxibustion treatment matches the individuals syndrome type. 2.Acupoint Prescription: SP20 (Spleen Shu) BL23 (Kidney Shu) ST36 (Zusanli) and SP6 (Sanyinjiao) were the core acupoints. Additional acupoints on the limbs abdomen and back were also selected to regulate the spleen and stomach energy kidney energy and the flow of Qi and blood in the meridians while also treating local symptoms based on syndrome differentiation. ·For patients with Qi deficiency and blood stasis syndrome acupoints CV4 (Guanyuan) CV6 (Qihai) and BL17 (Geshu) were additionally used. ·For patients with Yang deficiency and cold congelation syndrome acupoints GV14 (Dazhui) GV4 (Mingmen) and CV4 (Guanyuan) were used. ·For patients with phlegm and blood stasis obstructing the meridians syndrome acupoints ST40 (Fenglong) SP10 (Xuehai) and BL17 (Geshu) were used. ·For patients with liver and kidney deficiency acupoints BL18 (Liver Shu) and KI3 (Taixi) were used. ·For patients with numbness and pain in the upper limbs acupoints LI11 (Quchi) TE5 (Waiguan) and LI4 (Hegu) were added. ·For patients with severe numbness and pain in the lower limbs acupoints KI3 (Taixi) GB34 (Yanglingquan) and KI1 (Yongquan) were added. ·For patients with atrophy of the lower limbs acupoints GB39 (Xuanzhong) and ST32 (Futu) were added. 3.Acupoint Localization: The localization of acupoints was strictly conducted in accordance with the National Standard of the Peoples Republic of China for Names and Locations of Acupoints (GB/T 12346-2006). 4.Moxibustion Methods: ·Mild Moxibustion: A standard clear moxa stick was used. The ignited end was held 3-5 cm away from the skin with the temperature adjusted according to the patient's subjective feeling of warmth and comfort. For patients with sensory impairment the therapist monitored the temperature by placing the index and middle fingers on either side of the moxibustion point and adjusted the distance every 5 minutes until the skin turned slightly red. Where conditions permitted a thermometer was used to monitor the skin temperature which was controlled between 41°C and 43°C to prevent burns. ·Wenhe Moxibustion: The moxibustion box was placed centrally over the selected acupoints. An ignited moxa stick was placed inside the box 2-3 cm away from the metal screen. The temperature was regulated by opening and closing the box lid to maintain a warm and comfortable sensation without causing a burning pain. The skin reaction was checked every 10 minutes with the desired effect being a slight redness of the skin. After the moxibustion was completed the lid was opened to allow the box to cool for 5 minutes before it was removed. The moxa ash was then completely extinguished and disposed of properly. 5.Duration and Course of Treatment: ·The duration of moxibustion for each acupoint was controlled between 10-20 minutes with the total duration for a single session not exceeding 40 minutes. ·The treatment was divided into courses with each course consisting of six sessions. Two courses of moxibustion were conducted in total with a one-day interval between the courses.

纳入标准：

①年龄≥18岁，符合糖尿病周围神经病变诊断标准，且神经系统病变在确诊为糖尿病时或之后出现： 伴有明显自发性神经痛和麻木等神经病变症状，四肢感觉异常以下肢明显，呈灼痛、热痛、刀割样、虫咬样、撕裂样、针刺样疼痛，常伴夜间加重和（或）睡眠障碍； 肌电图检查神经传导速度有以下两项或两项以上减慢：正中神经、尺神经和腓总神经的运动传导速度和腓总神经、正中神经感觉传导速度； ②患者自愿参与研究并签署知情同意书。

Inclusion criteria

Inclusion Criteria Eligible participants were adults (≥18 years) with confirmed diabetic peripheral neuropathy (DPN) diagnosed after diabetes onset. Patients presented with characteristic neuropathic symptoms (spontaneous pain burning/lancinating sensations nocturnal exacerbation) predominantly in lower limbs confirmed by abnormal nerve conduction in ≥2 nerves (median/ulnar/peroneal motor or sensory nerves). All participants provided informed consent.

排除标准：

①合并非糖尿病等其他原因导致的周围神经病变者； ②伴有急性并发症者，如糖尿病酮症酸中毒、严重感染、下肢皮肤破溃或高渗性昏迷； ③皮肤感染、皮肤破损或艾灸部位存在严重皮肤病变者； ④对艾灸过敏的患者； ⑤近期接受过其他干预疗法（如针灸、中药浴足、理疗等），可能影响本研究结果的患者； ⑥妊娠或哺乳期妇女； ⑦有严重肝、肾、心功能不全、恶性肿瘤、心脑血管疾病、或严重精神病史的患者。

Exclusion criteria：

① Those who combine with peripheral neuropathy not caused by other reasons such as diabetes mellitus; ② Those with acute complications such as diabetic ketoacidosis severe infections skin breakdown of the lower limbs or hyperosmolar coma; ③ Those with skin infection skin breakdown or serious skin lesions in the moxibustion site; ④ Patients who are allergic to moxibustion; ⑤ Patients who have recently received other interventional therapies (e.g. acupuncture herbal foot baths physiotherapy etc.) that may affect the results of this study; (vi) Pregnant or lactating women; (vii) Patients with severe hepatic renal or cardiac insufficiency malignant tumours cardiovascular diseases or a history of severe mental illness. Translated with DeepL.com (free version)

研究实施时间：

Study execute time：

从From 2025-07-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-07-01

至To      2025-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

73

Group：

Control Group

Sample size：

干预措施：

常规护理

干预措施代码：

Intervention：

Conventional Nursing

Intervention code：

组别：

干预组

样本量：

73

Group：

Intervention Group

Sample size：

干预措施：

温和灸

干预措施代码：

Intervention：

Mild moxibustion

Intervention code：

样本总量 Total sample size ： 146

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅二医院

单位级别：

三级甲等

Institution/hospital：

The Second Xiangya Hospital of Central South University

Level of the institution：

Third-class hospital

测量指标：

Outcomes：

指标中文名：

自我调节疲劳量表

指标类型：

次要指标

Outcome：

Self-Regulatory Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Lubben社会网络量表

指标类型：

次要指标

Outcome：

Lubben Social Network Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

糖尿病生存质量特异性量表

指标类型：

次要指标

Outcome：

Diabetes Specific Quality of Life Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候评分标准

指标类型：

次要指标

Outcome：

Chinese Medicine Evidence Scoring Criteria

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

神经传导速度

指标类型：

次要指标

Outcome：

Nerve Conduction Velocity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多伦多临床评分系统(TCSS) 评分

指标类型：

主要指标

Outcome：

Torontoclinicalscoring system

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用随机数字表法，将146例合格受试者随机分为对照组和治疗组，每组73例。具体随机分配的操作由非本试验研究人员按照要求完成，随机分配卡用不透光的信封密封，按序号依次排好，由专人进行保管，当合格的受试者纳入分析研究时，按其进入的顺序拆开相同序号的信封，根据卡片的规定来确定受试者分组。将患者随机分为两组，即干预组（艾灸+常规护理）和对照组（常规护理）。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Using the random number table method 146 eligible subjects were randomly divided into a control group and a treatment group of 73 cases each. The operation of specific random allocation was completed by non-researchers of this trial according to the requirements and the random allocation cards were sealed in opaque envelopes sequentially arranged according to serial numbers and kept by a person and when qualified subjects were included in the analysed study the envelopes with the same serial numbers were opened in the order of their entry and the grouping of the subjects was determined according to the provisions of the cards. The patients were randomly divided into two groups i.e. the intervention group (moxibustion + usual care) and the control group (usual care). Translated with DeepL.com (free version)

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No share

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

一般资料由研究人员在患者入科后通过查阅病历获得。血糖血脂水平、睡眠质量、生活质量等干预数据于入科时及患者出院当天进行收集。患者依从性和安全性信息在干预过程中进行记录。两组患者的一般资料和结局指标收集时间保持一致。每次收集数据前，研究人员告知患者本次资料收集的目的和意义，并以统一的指导语进行数据采集。数据收集完成后，由两名研究人员进行核对，以确保无遗漏和信息填写的准确性。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

General information was obtained by the researchers by reviewing the medical records of the patients after their admission to the department. Intervention data such as pain scores blood glucose and lipid levels quality of sleep and quality of life were collected at the time of admission and on the day the patient was discharged. The exact end time of the intervention depended on evidence-based outcomes. Patient compliance and safety information was recorded during the intervention. General data and outcome indicators were collected at the same time for both groups of patients. Prior to each data collection patients were informed by the researchers of the purpose and significance of this data collection and data collection was conducted with uniform instructions. After data collection was completed it was checked by two researchers to ensure that there were no omissions and the information was filled in accurately.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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