Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Serum CRP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: acupuncture (Device)
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.
Intervention: conventional treatment (Other)
Control group
The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery.
Intervention: conventional treatment (Other)
Outcomes
Primary Outcomes
Serum CRP
Time Frame: 2 days after surgery
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 Outcomes
- Serum IL-6(within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery)
- fever(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.)
- infection sign(During the post operation day to 7 days after operation day,)
- Serum TNF-α(within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery)
- Serum CRP(within 48 h before the surgery, 4 days after surgery and 7 days after surgery)
- use of additional antibiotics(During the post operation day to 7 days after operation day)
- Serum erythrocyte sedimentation rate (ESR)(within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery)
- Serum IL-1β(within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery)
Investigators
Seong-Uk Park
KMD, PhD
Kyunghee University Medical Center