Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial
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 acupunc...
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| Format: | Article |
| Language: | English |
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BMC
2020-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04811-3 |
| _version_ | 1828961478448775168 |
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| author | Haiping Deng Yu Shu Peiran Lv Ling Zhao Ke Cheng Tingting Zhang Yi Song Hua Yang Hong Tang Jian Pei Xueyong Shen |
| author_facet | Haiping Deng Yu Shu Peiran Lv Ling Zhao Ke Cheng Tingting Zhang Yi Song Hua Yang Hong Tang Jian Pei Xueyong Shen |
| author_sort | Haiping Deng |
| collection | DOAJ |
| description | 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 . |
| first_indexed | 2024-12-14T09:45:47Z |
| format | Article |
| id | doaj.art-63e5a47aac444de8a237d6abf9819d38 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T09:45:47Z |
| publishDate | 2020-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-63e5a47aac444de8a237d6abf9819d382022-12-21T23:07:38ZengBMCTrials1745-62152020-10-0121111010.1186/s13063-020-04811-3Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trialHaiping Deng0Yu Shu1Peiran Lv2Ling Zhao3Ke Cheng4Tingting Zhang5Yi Song6Hua Yang7Hong Tang8Jian Pei9Xueyong Shen10School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineLong-Hua Hospital affiliated to Shanghai University of Traditional Chinese MedicineLong-Hua Hospital affiliated to Shanghai University of Traditional Chinese MedicineLong-Hua Hospital affiliated to Shanghai University of Traditional Chinese MedicineLong-Hua Hospital affiliated to Shanghai University of Traditional Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese MedicineAbstract 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 .http://link.springer.com/article/10.1186/s13063-020-04811-3AcupunctureDiabetic peripheral neuropathyRandomized controlled trialStudy protocol |
| spellingShingle | Haiping Deng Yu Shu Peiran Lv Ling Zhao Ke Cheng Tingting Zhang Yi Song Hua Yang Hong Tang Jian Pei Xueyong Shen Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial Trials Acupuncture Diabetic peripheral neuropathy Randomized controlled trial Study protocol |
| title | Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial |
| title_full | Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial |
| title_fullStr | Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial |
| title_full_unstemmed | Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial |
| title_short | Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial |
| title_sort | acupuncture for diabetic peripheral neuropathy study protocol for a randomized placebo controlled trial |
| topic | Acupuncture Diabetic peripheral neuropathy Randomized controlled trial Study protocol |
| url | http://link.springer.com/article/10.1186/s13063-020-04811-3 |
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