title: The quantity-effect relationship and physiological mechanisms of different acupuncture manipulations on posterior circulation ischemia with vertigo: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Recent experiments have demonstrated that different needling manipulations may induce variable effects via diverse physiological mechanisms. A previous study indicated that needling at Fengchi (GB 20) improved cerebral blood flow in patients with vertigo induced by posterior circulation ischemia (PCI). In this study, we aim to explore the quantity-effect relationship and the physiological mechanisms underlying different acupuncture manipulations in PCI patients with vertigo.
  
  
  METHODS
  We propose a pragmatic randomized and controlled trial. All participants, outcome assessors, and statisticians will be blinded. A total of 144 eligible participants will be randomized into one of four treatment groups receiving acupuncture at Fengchi (GB 20) with different one-minute manipulation parameters. Group 1 will receive twirling at a frequency of 60 times per minute toward the contralateral outer canthus at a depth of 0.5 to 0.8 cun. Group 2 will receive twirling at a frequency of 60 times per minute toward the Adam's apple at a depth of 0.5 to 0.8 cun. Group 3 will receive twirling at a frequency of 120 times per minute toward the contralateral outer canthus at a depth of 0.5 to 0.8 cun. Group 4 will receive twirling at a frequency of120 times per minute toward the Adam's apple at a depth of 0.5 to 0.8 cun. Additional points will be added based on individualized pattern diagnoses. The participants will receive 14 acupuncture sessions over 3 to 4 weeks. The subjects will be assessed at two time points: baseline and post-treatment. The primary outcome measurements will include subjective measurements (Vertebrobasilar System Ischemic Neurological Impairment Scale, UCLA Dizziness Questionnaire, Activities of Daily Living Scale, and Psychological and Social Adaptation Scale) and objective measurements (Transcranial Doppler, carotid ultrasonography and changes in cerebral oxygenation) to reduce bias arising from the placebo effect. We will use metabolomics to investigate the mechanisms underlying the different manipulation parameters.
  
  
  CONCLUSIONS
  This trial aims to explore the quantity-effect relationship between different acupuncture manipulations and their clinical effects. The results from this study may help explain the contradictory results found in acupuncture studies that practice different manipulations.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-RTRCC-12002675 (registered on 14 November 2012).
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. 18722498627@163.com.
authors: Shi-Zhe
authors: SZ
authors: Deng
authors: Institute of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, Tianjin, 300193, China. 1079315357@qq.com.
authors: Xiao-Feng
authors: XF
authors: Zhao
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. hlhzhenjiu@163.com.
authors: Ling-Hui
authors: LH
authors: Huang
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. azura0401@hotmail.com.
authors: Si
authors: S
authors: He
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. wenyan0907@126.com.
authors: Yan
authors: Y
authors: Wen
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. tonight.chao@163.com.
authors: Chao
authors: C
authors: Zhang
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. zghc_2008@163.com.
authors: Guang
authors: G
authors: Tian
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. 59825653@qq.com.
authors: Tian
authors: T
authors: Wang
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. journey2005_6_7@sina.com.
authors: Fen-Fen
authors: FF
authors: Wu
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. zhxf67@163.com.
authors: Zhi-Hong
authors: ZH
authors: Meng
authors: Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 314, West Anshan Avenue, 300193, Tianjin, China. tjdrshi@msn.com.
authors: Xue-Min
authors: XM
authors: Shi
mesh_terms: D000203:Activities of Daily Living; D015670:Acupuncture Therapy / Q000379:methods*; D002545:Brain Ischemia / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002681:China; D002985:Clinical Protocols; D003326:Coronary Circulation; D006801:Humans; D055432:Metabolomics; D020769:Posterior Cerebral Artery / Q000000981:diagnostic imaging / Q000378:metabolism / Q000503:physiopathology*; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial; D014717:Vertigo / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*