Clinical trial NCT02761096: Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Official title: Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unruptured Cerebral Aneurysm
Hemifacial Spasm
Brain Tumor
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyunghee University
First posted: 2016-05-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum CRP
timeFrame: 2 days after surgery
Secondary outcomes:
measure: Serum CRP
timeFrame: within 48 h before the surgery, 4 days after surgery and 7 days after surgery
measure: Serum erythrocyte sedimentation rate (ESR)
timeFrame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
measure: Serum TNF-α
timeFrame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
measure: Serum IL-1β
timeFrame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
measure: Serum IL-6
timeFrame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
measure: fever
timeFrame: 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.
measure: use of additional antibiotics
timeFrame: During the post operation day to 7 days after operation day
measure: infection sign
timeFrame: During the post operation day to 7 days after operation day,
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Seong-Uk Park, KMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho SY, Yang SB, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Park SU. Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial. Trials. 2017 Jan 10;18(1):10. doi: 10.1186/s13063-016-1712-7.