Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Hemifacial Spasm; Unruptured Cerebral Aneurysm
• Intervention / Treatment: Device: acupuncture; Other: conventional treatment

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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.	Device: acupuncture; Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session. Sterile disposable stainless steel acupuncture needles (0.25 mm × 30 mm) will be used. Acupuncture needles will be inserted bilaterally at the following acupuncture points: LI4, LI11, PC6, ST36, GB39 and LR3, and GV20. If GV20 is close to the surgical site, this acupoint may be excluded. An electric stimulator will be connected to the handle of each needle at LI4, LI11, ST36, and LR3 and a current of 5 Hz will be applied. After the needles are removed, intradermal acupuncture needles with tape (DB130A; 0.25 mm × 1.5mm) will be inserted at the same acupoints (LI4, LI11, PC6, ST36, GB39, and LR3 bilaterally, and GV20) and left in place until the next session.; Other: conventional treatment; The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery and includes stabilizing vital signs, pain control, prevention and treatment of infections, and other IV fluid or drug therapy required based on the condition of the patient.
Other: Control group; The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.	Other: conventional treatment; The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery and includes stabilizing vital signs, pain control, prevention and treatment of infections, and other IV fluid or drug therapy required based on the condition of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum CRP	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.	2 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum CRP	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.	within 48 h before the surgery, 4 days after surgery and 7 days after surgery
Serum erythrocyte sedimentation rate (ESR)	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum TNF-α	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum IL-1β	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum IL-6	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
fever	Any fever with a body temperature over 38℃ will be recorded on the case report form.	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.
use of additional antibiotics	Use of additional antibiotics will be recorded on the case report form.	During the post operation day to 7 days after operation day
infection sign	Infections such as pneumonia or urinary tract infections will be recorded on the case report form.	During the post operation day to 7 days after operation day,

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Kyunghee University
• Investigators: Principal Investigator: Seong-Uk Park, KMD, PhD, Kyung Hee University Hospital at Gangdong

Publications and helpful links

General Publications

• Cho SY, Yang SB, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Park SU. Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial. Trials. 2017 Jan 10;18(1):10. doi: 10.1186/s13063-016-1712-7. Erratum In: Trials. 2017 Oct 16;18(1):481.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; Neuromuscular Manifestations; Intracranial Arterial Diseases; Spasm; Inflammation; Aneurysm; Intracranial Aneurysm; Hemifacial Spasm
• Other Study ID Numbers: 20152152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No