Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Conditions
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Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor

Intervention / Treatment
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* Device: acupuncture
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* 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.<br>Other: conventional treatment<br>* 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.<br>|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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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, |