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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial

Authors: Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park

Published in: Trials | Issue 1/2017

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ClinicalTrials.gov: NCT02761096. Registered on 27 April 2016.
Appendix
Available only for authorised users
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Metadata
Title
Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial
Authors
Seung-Yeon Cho
Seung-Bo Yang
Hee Sup Shin
Seung Hwan Lee
Jun Seok Koh
Seungwon Kwon
Woo-Sang Jung
Sang-Kwan Moon
Jung-Mi Park
Chang-Nam Ko
Seong-Uk Park
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1712-7

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