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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | acupuncture, electroacupuncture and intradermal acupuncture are done at every session. |
|
| Control group | Sham Comparator | Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of delayed ischemic neurological deficit | The occurrence of delayed ischemic neurological deficit between the study group and the control group will be compared. DIND is defined as an unaccountable new focal neurological deficit lasting more than 2hours. Any occurrence of DIND will be recorded by the physician and verified by the investigator every day. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of angiographic vasospasm | Angiographic vasospasm is defined as focal or generalized reduction of cerebral arterial caliber on conventional cerebral angiogram or computed tomographic angiography confirmed by a neuroradiologist and neurosurgeon. | 14 days |
| The incidence of TCD vasospasm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Uk Park, KMD, PhD | Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | Gangdong-gu | 05278 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35294135 | Derived | Wei JJ, Guo RJ, Fu GJ, Liang X, Xu ZM, Jia M, Zeng ZX, Du WQ, Jiao WW, Sun LJ, Liu HM, Guo CL, Tong CG, Zhang YL, Liao X. Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review. J Tradit Chin Med. 2022 Feb;42(1):148-153. doi: 10.19852/j.cnki.jtcm.2022.01.010. | |
| 32876468 |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020301 | Vasospasm, Intracranial |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
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| Electroacupuncture | Device | The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz. |
|
| Intradermal acupuncture | Device | Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session. |
|
| Mock transcutaneous electrical nerve stimulation | Device | 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. |
|
|
| sham intradermal acupuncture | Device | Intradermal acupuncture needles are put over the tape not penetrating the skin. |
|
TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >3 |
| 14 days |
| The incidence of vasospasm-related infarct on CT or MRI | It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI | 14 days |
| The change of nitric oxide(NO) and endothelin-1 in plasma | Blood sample of 3ml is taken from brachial vein and centrifuged by 3000 rpm for 15minutes and kept in a freezer before analysis. Blood sample will be taken twice, before the start of treatment and after the end of treatment. In addition, the level of serum NO and endothelin-1 between patients and healthy controls will be compared. | 14days |
| Mortality | Mortality at the end of treatment and 14days after the treatment(or at discharge) | 14 days and 28 days |
| modified Rankin Scale (mRS) | The participan's functional status at the end of treatment and 14days after the treatment | 14 days and 28 days |
| Derived |
| Lee DH, Cho SY, Yang SB, Lee HM, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. Efficacy of Acupuncture Treatment to Prevent Cerebral Vasospasm After Subarachnoid Hemorrhage: A Double-Blind, Randomized Placebo-Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1182-1189. doi: 10.1089/acm.2020.0156. Epub 2020 Sep 1. |
| 25886483 | Derived | Cho SY, Lee DH, Shin HS, Lee SH, Koh JS, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2015 Feb 28;16:68. doi: 10.1186/s13063-015-0591-7. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |