The quantity-effect relationship and physiological mechanisms of different acupuncture manipulations on posterior circulation ischemia with vertigo: study protocol for a randomized controlled trial
Autor: | Chao Zhang, Guang Tian, Xiao-Feng Zhao, Si He, Xuemin Shi, Ling-Hui Huang, Zhihong Meng, Fen-Fen Wu, Shi-Zhe Deng, Yan Wen, Tian Wang |
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Jazyk: | angličtina |
Předmět: |
Quantity-effect relationship
China medicine.medical_specialty Time Factors Ultrasonography Doppler Transcranial Acupuncture Therapy Ischemia Medicine (miscellaneous) Posterior cerebral artery Brain Ischemia Brain ischemia Study Protocol Clinical Protocols Coronary Circulation Surveys and Questionnaires Vertigo medicine.artery Activities of Daily Living Acupuncture Humans Metabolomics Medicine Pharmacology (medical) cardiovascular diseases Posterior Cerebral Artery Dry needling biology business.industry biology.organism_classification medicine.disease Surgery Treatment Outcome Cerebral blood flow Research Design Anesthesia Conventional PCI Quality of Life business |
Zdroj: | Trials |
ISSN: | 1745-6215 |
DOI: | 10.1186/s13063-015-0660-y |
Popis: | 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/Design 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. Discussion 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. Trial registration Chinese Clinical Trial Registry: ChiCTR-RTRCC-12002675 (registered on 14 November 2012). |
Databáze: | OpenAIRE |
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