Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial
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STUDY PROTOCOL
Open Access
Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial Haiping Deng1,2†, Yu Shu1†, Peiran Lv1, Ling Zhao1, Ke Cheng1,2, Tingting Zhang1, Yi Song3, Hua Yang3, Hong Tang3, Jian Pei3*† and Xueyong Shen1*†
Abstract Background: Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN. Methods/design: This is a study protocol for a randomized, placebo-controlled clinical trial. A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12 weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients. Discussion: This trial may provide high-quality evidence for evaluating the efficacy and safety of MA treatment for DPN compared with SA treatment. Results of this study will be published in peer-reviewed journals. Trial registration: Chinese Clinical Trials Registry ChiCTR1800020444. First registered on 29 December 2018, retrospectively registered, http://www.chictr.org.cn/showproj.aspx?Proj=31063. Keywords: Acupuncture, Diabetic peripheral neuropathy, Randomized controlled trial, Study protocol
* Correspondence: [email protected]; [email protected] † Haiping Deng, Yu Shu, Jian Pei and Xueyong Shen contributed equally to this work. 3 Long-Hua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Xuhui District, Shanghai, China 1 School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Pudong District, Shanghai, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons li
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