Fang-Ting Yu1,2, Guang-Xia Ni3, Guo-Wei Cai4, Wen-Jun Wan5, Xiao-Qing Zhou6, Xiu-Li Meng7, Jin-Ling Li1,2, Jian-Feng Tu1,2, Li-Qiong Wang1,2, Jing-Wen Yang1,2, Hai-Yang Fu8, Xin-Chang Zhang3, Jing Li4, Yan-Fu Wang5, Beng Zhang6, Xiao-Hui Zhang9, Hao-Lin Zhang9, Guang-Xia Shi10,11, Cun-Zhi Liu1,2,12. 1. International Acupuncture and Moxibustion Innovation Institute, Beijing University of Chinese Medicine, Beijing, 100029, China. 2. Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China. 3. Nanjing University of Chinese Medicine, Nanjing, 210023, China. 4. Department of Acupuncture, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China. 5. Department of Rehabilitation, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430014, China. 6. Shenzhen Hospital, Beijing University of Chinese Medicine, Shenzhen, 518100, China. 7. Pain Medicine Center, Peking University Third Hospital, Beijing, 100191, China. 8. Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, China. 9. Department of Traditional Chinese Medicine, Peking University of Third Hospital, Beijing, 100191, China. 10. International Acupuncture and Moxibustion Innovation Institute, Beijing University of Chinese Medicine, Beijing, 100029, China. shiguangxia2008@126.com. 11. Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China. shiguangxia2008@126.com. 12. Department of acupuncture, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.
Abstract
BACKGROUND:Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. METHODS: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. DISCUSSION: The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. TRIAL REGISTRATION: ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 9 March 2020).
RCT Entities:
BACKGROUND: Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. METHODS: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. DISCUSSION: The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. TRIAL REGISTRATION: ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn , registered on 9 March 2020).
Authors: David A Grimes; David Hubacher; Kavita Nanda; Kenneth F Schulz; David Moher; Douglas G Altman Journal: Lancet Date: 2005 Jul 9-15 Impact factor: 79.321