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A randomized controlled trial of acupuncture and moxibustion to treat Bell's palsy according to different stages: design and protocol.

Abstract
Acupuncture to treat Bell's palsy is one of the most commonly used methods in China. There are a variety of acupuncture treatment options to treat Bell's palsy in clinical practice. Since Bell's palsy has three different path-stages (acute stage, resting stage and restoration stage), so whether acupuncture is effective in the different path-stages and which acupuncture treatment is the best method are major issues in acupuncture clinical trials about Bell's palsy. In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with acupuncture. There are five acupuncture groups, with four according to different path-stages and one not. In total, 900 patients with Bell's palsy are enrolled in this study. These patients are randomly assigned to receive one of the following four treatment groups according to different path-stages, i.e. 1) staging acupuncture group, 2) staging acupuncture and moxibustion group, 3) staging electro-acupuncture group, 4) staging acupuncture along yangming musculature group or non-staging acupuncture control group. The outcome measurements in this trial are the effect comparison achieved among these five groups in terms of House-Brackmann scale (Global Score and Regional Score), Facial Disability Index scale, Classification scale of Facial Paralysis, and WHOQOL-BREF scale before randomization (baseline phase) and after randomization. The result of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's palsy.
AuthorsXiaoqin Chen, Ying Li, Hui Zheng, Kaming Hu, Hongxing Zhang, Ling Zhao, Yan Li, Lian Liu, Lingling Mang, Shuyuan Yu
JournalContemporary clinical trials (Contemp Clin Trials) Vol. 30 Issue 4 Pg. 347-53 (Jul 2009) ISSN: 1559-2030 [Electronic] United States
PMID19281871 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Topics
  • Acupuncture Therapy
  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Bell Palsy (physiopathology, therapy)
  • Clinical Protocols
  • Disability Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Moxibustion
  • Research Design
  • Severity of Illness Index
  • Time Factors
  • Young Adult

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