NCT02275949

Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Kyung Hee University Hospital at Gangdong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate acupuncture's effect of preventing vasospasm after SAH. A total of 80 participants will be recruited and will be randomized to a study group or a control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at every session in a study group, while mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture will be carried out in a control group.

Detailed description

Intervention starts within 96hours after SAH, after ruptured aneurysms have been secured by endovascular coiling or surgical clipping. Intervention is applied once a day, 6 days a week for 2 weeks(total 12 sessions) in addition to standard treatment such as prophylactic HHH therapy and nimodipine. Sterile disposable, stainless steel acupuncture needles are used. Primary outcome measurement is the occurrence of delayed ischemic neurological deficit between the study group and the control group. Moreover, the incidence of angiographic vasospasm, TCD vasospasm, and vasospasm-related infarct on CT or MRI, the change of nitric oxide(NO) and endothelin-1 in plasma, mortality and participant's functional status using mRS will be compared.

Conditions

• SAH (Subarachnoid Hemorrhage)
• Cerebral Vasospasm

Interventions

Type	Name	Description
DEVICE	acupuncture	Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
DEVICE	Electroacupuncture	The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
DEVICE	Intradermal acupuncture	Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
DEVICE	Mock transcutaneous electrical nerve stimulation	Electrical insulator are attached on the ST36 and PC6 bilaterally, the same electric stimulator will be connected on the points with the same parameters as the study group, but without current intensity.
DEVICE	sham intradermal acupuncture	Intradermal acupuncture needles are put over the tape not penetrating the skin.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-10-27
• Last updated: 2018-08-08

Locations

1 site across 1 country: South Korea