Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Kyung Hee University

Status: Completed

Conditions: Brain Tumor; Unruptured Cerebral Aneurysm; Hemifacial Spasm

Treatments: Device: acupuncture; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02761096

20152152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Study group

Experimental group

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.

Treatment:

Other: conventional treatment

Device: acupuncture

Control group

Other group

Description:

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

Treatment:

Other: conventional treatment