ClinicalTrials.Veeva

Menu

Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

K

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems