Back to resultsEffect of Acupuncture on Inflammation and Immune Function After Craniotomy
Primary Purpose
Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture
conventional treatment
Sponsored by
About this trial
This is an interventional prevention trial for Unruptured Cerebral Aneurysm
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria in order to be included:
- planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
- age > 18 years;
- acupuncture treatment that can start within 48 h after craniotomy;
- voluntary participation and provision of signed informed consent form.
Exclusion Criteria:
Participants with any of the following conditions will be excluded:
- serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
- a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
- craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
- 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;
- a history of surgery at the same site;
- emergency surgery; or
- a severe medical disease, e.g. congestive heart failure, chronic renal failure.
Sites / Locations
- Kyung Hee University Hospital at Gangdong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study group
Control group
Arm Description
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.
The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
fever
Any fever with a body temperature over 38℃ will be recorded on the case report form.
use of additional antibiotics
Use of additional antibiotics will be recorded on the case report form.
infection sign
Infections such as pneumonia or urinary tract infections will be recorded on the case report form.
Full Information
NCT ID
NCT02761096
First Posted
April 27, 2016
Last Updated
February 26, 2019
Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
1. Study Identification
Unique Protocol Identification Number
NCT02761096
Brief Title
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Official Title
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum CRP
Description
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.
Time Frame
2 days after surgery
Secondary Outcome Measure Information:
Title
Serum CRP
Description
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.
Time Frame
within 48 h before the surgery, 4 days after surgery and 7 days after surgery
Title
Serum erythrocyte sedimentation rate (ESR)
Description
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.
Time Frame
within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Title
Serum TNF-α
Description
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.
Time Frame
within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Title
Serum IL-1β
Description
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.
Time Frame
within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Title
Serum IL-6
Description
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.
Time Frame
within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Title
fever
Description
Any fever with a body temperature over 38℃ will be recorded on the case report form.
Time Frame
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.
Title
use of additional antibiotics
Description
Use of additional antibiotics will be recorded on the case report form.
Time Frame
During the post operation day to 7 days after operation day
Title
infection sign
Description
Infections such as pneumonia or urinary tract infections will be recorded on the case report form.
Time Frame
During the post operation day to 7 days after operation day,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria in order to be included:
planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
age > 18 years;
acupuncture treatment that can start within 48 h after craniotomy;
voluntary participation and provision of signed informed consent form.
Exclusion Criteria:
Participants with any of the following conditions will be excluded:
serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
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;
a history of surgery at the same site;
emergency surgery; or
a severe medical disease, e.g. congestive heart failure, chronic renal failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Uk Park, KMD, PhD
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28069040
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
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