Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Unruptured Cerebral Aneurysm Hemifacial Spasm Brain Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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.

conventional treatment

Intervention Type OTHER

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.

Control group

The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.

Group Type OTHER

conventional treatment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No