Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Brain Tumor Clinical Trial

Official title:

Effect of Acupuncture on Inflammation and Immune Function After Craniotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761096
• Other study ID #: 20152152
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2019
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Brain Tumor
• Hemifacial Spasm
• Inflammation
• Intracranial Aneurysm
• Unruptured Cerebral Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	within 48 h before the surgery, 4 days after surgery and 7 days after surgery
Secondary	Serum erythrocyte sedimentation rate (ESR)	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Secondary	Serum TNF-a	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Secondary	Serum IL-1ß	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Secondary	Serum IL-6	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.	within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Secondary	fever	Any fever with a body temperature over 38? will be recorded on the case report form.	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.
Secondary	use of additional antibiotics	Use of additional antibiotics will be recorded on the case report form.	During the post operation day to 7 days after operation day
Secondary	infection sign	Infections such as pneumonia or urinary tract infections will be recorded on the case report form.	During the post operation day to 7 days after operation day,