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Author (up) Cho, S.-Y.; Lee, D.-H.; Shin, H.S.; Lee, S.H.; Koh, J.S.; Jung, W.-S.; Moon, S.-K.; Park, J.-M.; Ko, C.-N.; Kim, H.; Park, S.-U. url  doi
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  Title The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial Type of Study Journal Article
  Year 2015 Publication Trials Abbreviated Journal Trials  
  Volume 16 Issue 1 Pages 68-68  
  Keywords  
  Abstract Background: Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate. Several serious complications frequently arise after successful surgery for this condition. Cerebral vasospasm, one such complication, occurs in 50 to 70% of SAH patients. These patients suffer neurological symptoms known as delayed ischemic neurological deficit (DIND); however, the effect of treatment of vasospasm is limited. The major pathogenesis of cerebral vasospasm is the reduction of nitric oxide (NO) and activation of vasoconstrictors. Acupuncture is known to increase the production and activity of vascular endothelial cell-derived NO and improve endothelium-dependent vasodilatation. A preliminary retrospective case study to investigate the ability of acupuncture to prevent the occurrence of cerebral vasospasm has been conducted. However, no randomized, controlled clinical trials have been carried out to evaluate the efficacy of acupuncture for cerebral vasospasm.Methods/design: This trial will be a single-center, randomized, placebo-controlled, parallel group, patient-assessor-blinded clinical trial. A total of 80 patients with SAH will be randomized into two groups: a study group given acupuncture, electroacupuncture, and intradermal acupuncture, and a control group given mock transcutaneous electrical nerve stimulation and sham intradermal acupuncture. Intervention will start within 96 h after SAH, and a total of 12 sessions will be performed during a 2-week period. The primary outcome measure will be the occurrence of DIND, and the secondary outcomes will be vasospasm as measured by cerebral angiography, transcranial Doppler, clinical symptoms, vasospasm-related infarcts, NO and endothelin-1 plasma levels, mortality, and modified Rankin Scale scores.Discussion: This trial will examine the efficacy and safety of acupuncture for cerebral vasospasm after SAH. The placebo effect will be excluded and the mechanism of action of the treatments will be evaluated through blood testing.Trial Registration: ClinicalTrials.gov NCT02275949 , Registration date: 26 October 2014.  
  Address  
  Publisher BioMed Central
  Language Number of Treatments  
  Treatment Follow-up Frequency Number of Participants  
  Time in Treatment Condition
  Disease Category OCSI Score  
  Notes Accession Number: 109724256. Language: English. Entry Date: 20150923. Revision Date: 20161223. Publication Type: journal article; research; randomized controlled trial. Journal Subset: Biomedical; Europe; UK & Ireland. NLM UID: 101263253. Approved no  
  Call Number OCOM @ refbase @ 109724256 Serial 2345  
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