title: Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial.
abstract: Despite recent advances in the medical and surgical fields, complications such as infection, pneumonia, or brain swelling may occur after a craniotomy. In some patients, perioperative antibiotic prophylaxis causes adverse effects such as itching, rash, or digestive conditions. Certain patients still develop infections severe enough to require a repeat operation despite antibiotic prophylaxis. Acupuncture has been used to treat inflammatory conditions, and many basic and clinical studies have provided evidence of its anti-inflammatory and immune regulatory effects. The aim of this study is to explore the effects of acupuncture on inflammation and immune function after craniotomy.
  
  
  
  This trial will be a single-center, parallel-group clinical trial. Forty patients who underwent craniotomy for an unruptured aneurysm, facial spasm, or a brain tumor will be allocated to either the study or the control group. The study group will receive conventional management as well as acupuncture, electroacupuncture, and intradermal acupuncture, which will start within 48 h of the craniotomy. The patients will receive a total of six sessions within 8 days. The control group will only receive conventional management. The primary outcome measure will be the C-reactive protein levels, while the secondary outcomes will be the serum erythrocyte sedimentation rate and the tumor necrosis factor-α, interleukin (IL)-1β, and IL-6 levels measured at four different time points: within 48 h prior to the craniotomy and on days 2, 4, and 7 after surgery. The presence of fever and infection, the use of additional antibiotics, the presence of infection, including pneumonia or urinary tract infection, and safety will also be investigated.
  
  
  
  In this trial, we will observe whether acupuncture has anti-inflammatory and immune regulatory effects after a craniotomy. If our study yields positive results and a placebo-controlled study also finds favorable results following our study, acupuncture could be recommended as an adjunctive therapy after a craniotomy.
  
  
  
  ClinicalTrials.gov: NCT02761096 . Registered on 27 April 2016.
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Seung-Yeon
authors.initials: SY
authors.lastname: Cho
authors.affiliation: Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Seung-Bo
authors.initials: SB
authors.lastname: Yang
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Hee Sup
authors.initials: HS
authors.lastname: Shin
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Seung Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Jun Seok
authors.initials: JS
authors.lastname: Koh
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Seungwon
authors.initials: S
authors.lastname: Kwon
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Woo-Sang
authors.initials: WS
authors.lastname: Jung
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
authors.forename: Sang-Kwan
authors.initials: SK
authors.lastname: Moon
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Jung-Mi
authors.initials: JM
authors.lastname: Park
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
authors.forename: Chang-Nam
authors.initials: CN
authors.lastname: Ko
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. seonguk.kr@gmail.com.|Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea. seonguk.kr@gmail.com.
authors.forename: Seong-Uk
authors.identifier: 0000-0002-4617-2719
authors.initials: SU
authors.lastname: Park
mesh_terms: D015670:Acupuncture Therapy; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000032:analysis; D002985:Clinical Protocols; D003399:Craniotomy; D006801:Humans; D007249:Inflammation / Q000517:prevention & control*; D015850:Interleukin-6 / Q000097:blood; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein
keywords: Acupuncture; Craniotomy; Electroacupuncture; Immune function; Inflammation; Neurosurgery