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Completed

NCT Number: NCT02761096

Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Serum CRP

    Time frame: within 48 h before the surgery, 4 days after surgery and 7 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.

  2. Serum erythrocyte sedimentation rate (ESR)

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

    The photometrical capillary method will be performed for measurement of ESR. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

  3. Serum TNF-α

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

    Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

  4. Serum IL-1β

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

    Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

  5. Serum IL-6

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

    Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.

  6. fever

    Time frame: 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.

    Any fever with a body temperature over 38℃ will be recorded on the case report form.

  7. use of additional antibiotics

    Time frame: During the post operation day to 7 days after operation day

    Use of additional antibiotics will be recorded on the case report form.

  8. infection sign

    Time frame: During the post operation day to 7 days after operation day,

    Infections such as pneumonia or urinary tract infections will be recorded on the case report form.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Kyunghee University

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2016
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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