Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial.

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).

• Authors: Fang-Ting Yu, Guang-Xia Ni, Guo-Wei Cai, Wen-Jun Wan, Xiao-Qing Zhou, Xiu-Li Meng, Jin-Ling Li, Jian-Feng Tu, Li-Qiong Wang, Jing-Wen Yang, Hai-Yang Fu, Xin-Chang Zhang, Jing Li, Yan-Fu Wang, Beng Zhang, Xiao-Hui Zhang, Hao-Lin Zhang, Guang-Xia Shi, Cun-Zhi Liu
• Journal: Trials (Trials) Vol. 22 Issue 1 Pg. 34 (Jan 07 2021) ISSN: 1745-6215 [Electronic] England
• PMID: 33413608 (Publication Type: Clinical Trial Protocol, Journal Article)

Topics

• Acupuncture Therapy (adverse effects)
• Humans
• Multicenter Studies as Topic
• Pilot Projects
• Quality of Life
• Randomized Controlled Trials as Topic
• Sciatica (diagnosis, therapy)
• Time Factors
• Treatment Outcome