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. 2024 Apr 2;14(4):e079354.
doi: 10.1136/bmjopen-2023-079354.

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

Rong Zhuang  1 , Zhiyi Xiong  1 , Shiyan Yan  2 , Haoran Zhang  3 , Qi Dong  4 , Weiai Liu  5 , Jinling Miao  6 , Yuanyuan Zhuo  7 , Xiaohong Fan  4 , Weiliang Zhang  4 , Xiaomei Wang  4 , Lian Liu  5 , Jianan Cao  5 , Tiansheng Zhang  6 , Chongyao Hao  6 , Xingxian Huang  7 , Lijiao Jiang  8
Affiliations

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

Rong Zhuang et al. BMJ Open. .

Abstract

Introduction: Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.

Methods and analysis: This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population.

Ethics and dissemination: The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.

Trial registration number: ChiCTR2200061408.

Keywords: COMPLEMENTARY MEDICINE; Diabetic neuropathy; Randomised Controlled Trial.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial flow chart of or the selection of study participants, including the process of enrolment, allocation, follow-up and analysis.
Figure 2
Figure 2
Location of acupoints and non-acupuncture points. Yellow dots: location of acupoints in the electro-acupuncture group; blue dots: location of non-acupuncture points in the sham acupuncture group. (Note: This figure is modified based on www.3Dbody.com). (A) Medial aspect view of the lower extremity; (B) anterior aspect view of the lower extremity; (C) lateral aspect view of the lower extremity; (D) view of the upper extremity.
Figure 3
Figure 3
The piercing diagram of the sham acupuncture Note: 1+2+3: blunt needle: 1—needle handle, 2—needle body, 3—the blunt tip of the needle; 4—base unit; 5—skin.
See this image and copyright information in PMC

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