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Acupuncture for chronic sciatica: protocol for a multicenter randomised controlled trial

Authors :
Fang-Ting Yu
Cun-Zhi Liu
Guang-Xia Ni
Guo-Wei Cai
Zhi-Shun Liu
Xiao-Qing Zhou
Chao-Yang Ma
Xiu-Li Meng
Jian-Feng Tu
He-Wen Li
Jing-Wen Yang
Shi-Yan Yan
Hai-Yang Fu
Wen-Tao Xu
Jing Li
Hong-Chun Xiang
Tian-Heng Sun
Beng Zhang
Mei-Hua Li
Wen-Jun Wan
Cheng He
Xiao-Lan Ji
Wei Zhu
Guang-Xia Shi
Li-Qiong Wang
Source :
BMJ Open. 12:e054566
Publication Year :
2022
Publisher :
BMJ, 2022.

Abstract

BackgroundChronic Sciatica is a disabling condition causing considerable medical, social and financial implications. Currently, there is no recognised long-term effective treatment to alleviate sciatica. Acupuncture has been widely used for treating chronic pains with persistent analgesic effects. We aim to evaluate the efficacy and safety of acupuncture for chronic sciatica with follow-up in 52 weeks.Methods and analysisThis is a multicenter randomised sham-controlled trial. A total of 216 patients with chronic sciatica will be enrolled and randomly assigned to the acupuncture or sham acupuncture group. There will be 10 treatment sessions applied in 4 weeks with frequency decreased over time. Patients will complete follow-ups during 52 weeks. The primary outcomes are changes in leg pain intensity and disability from baseline to week 4. Secondary outcomes include back pain intensity, frequency and bothersomeness, quality of life, and global perceived effect. Adverse events will be recorded in detail.Ethics and disseminationEthical approval of this trial was granted from the ethics committee of Beijing University of Chinese Medicine and all study centres (No. 2020BZYLL0803). Written informed consent will be obtained from enrolled patients. Trial results will be disseminated in peer-reviewed publications.Trial registration numberChiCTR2100044585 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 24 March 2021); preresults.

Details

ISSN :
20446055
Volume :
12
Database :
OpenAIRE
Journal :
BMJ Open
Accession number :
edsair.doi.dedup.....985fa29ba59c643a7b2525bb898617e8