Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Not Applicable

Completed

• Conditions: Hemifacial Spasm; Unruptured Cerebral Aneurysm; Brain Tumor
• Interventions: Other: conventional treatment; Device: acupuncture

• Registration Number: NCT02761096
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

The aim of this study is to evaluate the effect of acupuncture on inflammation and immune function after craniotomy. This study will be a single-center, parallel group clinical trial that will be conducted at Kyung Hee University Hospital at Gangdong, Seoul, Korea.

Detailed Description

For Study group, The intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session.

For Control group, The subjects in the control group will only receive conventional treatment.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-04
• Primary Completion: 2017-05
• Study Completion: 2017-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Participants must meet all of the following criteria in order to be included:

1. planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
2. age > 18 years;
3. acupuncture treatment that can start within 48 h after craniotomy;
4. voluntary participation and provision of signed informed consent form.

Exclusion Criteria

Participants with any of the following conditions will be excluded:

1. serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
2. a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
3. craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
4. medication use that can affect the immune system or white blood cell (WBC) count, such as immunosuppressive drugs, steroids, or anticancer drugs or use of these medications within one month prior to the craniotomy;
5. a history of surgery at the same site;
6. emergency surgery; or
7. a severe medical disease, e.g. congestive heart failure, chronic renal failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	conventional treatment	The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.
Study group	acupuncture	The acupuncture intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). It will be given in addition to conventional treatments. All interventions will be performed by one Korean Medicine doctor with over 5 years of working experience with a college education of 6 years. This doctor will be trained in the study protocol before the start of the trial.
Study group	conventional treatment	The acupuncture intervention will start no more than 48 hours after craniotomy and will be given once a day for 6 days (a total of 6 sessions within 8 days). It will be given in addition to conventional treatments. All interventions will be performed by one Korean Medicine doctor with over 5 years of working experience with a college education of 6 years. This doctor will be trained in the study protocol before the start of the trial.

Primary Outcome Measures

Name	Time	Method
Serum CRP	2 days after surgery	Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

Secondary Outcome Measures

Name	Time	Method
Serum IL-6	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery	Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.
fever	During the post operation day to 7 days after operation day. Body temperature will be measured at 6:00, 10:00, 18:00, and 22:00 every day.	Any fever with a body temperature over 38℃ will be recorded on the case report form.
infection sign	During the post operation day to 7 days after operation day,	Infections such as pneumonia or urinary tract infections will be recorded on the case report form.
Serum TNF-α	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery	Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.
Serum CRP	within 48 h before the surgery, 4 days after surgery and 7 days after surgery	Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.
use of additional antibiotics	During the post operation day to 7 days after operation day	Use of additional antibiotics will be recorded on the case report form.
Serum erythrocyte sedimentation rate (ESR)	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery	The photometrical capillary method will be performed for measurement of ESR. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.
Serum IL-1β	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery	Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of