International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Departrment of Acupuncture, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
BMJ Open. 2022 May 17;12(5):e054566. doi: 10.1136/bmjopen-2021-054566.
Chronic 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.
This 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.
Ethical 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.
ChiCTR2100044585 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 24 March 2021); preresults.
慢性坐骨神经痛是一种致残性疾病，会带来相当大的医疗、社会和经济影响。目前，尚无公认的长期有效治疗方法来缓解坐骨神经痛。针灸已广泛用于治疗慢性疼痛，并具有持续的镇痛效果。我们旨在评估针灸治疗慢性坐骨神经痛的疗效和安全性，并进行 52 周的随访。
这是一项多中心随机对照假针刺临床试验。将招募 216 名慢性坐骨神经痛患者，并随机分为针刺组或假针刺组。在 4 周内进行 10 次治疗，随着时间的推移，治疗频率逐渐降低。患者将在 52 周内完成随访。主要结局是从基线到第 4 周时腿部疼痛强度和残疾程度的变化。次要结局包括腰背疼痛强度、频率和困扰程度、生活质量和整体感知效果。详细记录不良事件。
本试验已获得北京中医药大学和所有研究中心的伦理委员会的批准（编号 2020BZYLL0803）。将从入组患者处获得书面知情同意。试验结果将在同行评议的出版物中公布。
ChiCTR2100044585（中国临床试验注册中心，http://www.chictr.org.cn，于 2021 年 3 月 24 日注册）；预注册结果。
