Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

NCT02761096 | Completed DMC

• 1 other identifier: 20152152
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Unruptured Cerebral Aneurysm; Hemifacial Spasm; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Serum CRP

  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.

  2 days after surgery

Secondary Outcomes (8)

• Serum CRP

  within 48 h before the surgery, 4 days after surgery and 7 days after surgery

• 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 TNF-α

  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

• Serum IL-6

  within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery

Study Arms (2)

Study group

EXPERIMENTAL

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.

Device: acupuncture; Other: conventional treatment

Control group

OTHER

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

Other: conventional treatment

Interventions

acupuncture 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.

Study group

conventional treatment 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; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Kyunghee University: collaborator

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28069040 DERIVED

MeSH Terms

Conditions

Hemifacial Spasm; Brain Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Seong-Uk Park, KMD, PhD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KMD, PhD

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)