| Autor: |
Xiaomei Wang, Qi Dong, Lian Liu, Rong Zhuang, Zhiyi Xiong, Shiyan Yan, Haoran Zhang, Weiai Liu, Jinling Miao, Yuanyuan Zhuo, Xiaohong Fan, Weiliang Zhang, Jianan Cao, Tiansheng Zhang, Chongyao Hao, Xingxian Huang, Lijiao Jiang |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
BMJ Open, Vol 14, Iss 4 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2044-6055 |
| DOI: |
10.1136/bmjopen-2023-079354 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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