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Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761096
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Kyunghee University
Information provided by (Responsible Party):
Seong-Uk Park, Kyunghee University Medical Center

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.

Condition or disease Intervention/treatment Phase
Unruptured Cerebral Aneurysm Hemifacial Spasm Brain Tumor Device: acupuncture Other: conventional treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: 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.
Device: acupuncture

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.


Other: conventional treatment
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
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
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761096


Locations
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Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 05278
Sponsors and Collaborators
Kyunghee University Medical Center
Kyunghee University
Investigators
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Principal Investigator: Seong-Uk Park, KMD, PhD Kyung Hee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seong-Uk Park, KMD, PhD, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02761096    
Other Study ID Numbers: 20152152
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hemifacial Spasm
Intracranial Aneurysm
Aneurysm
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Mouth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms