Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
NCT Number: NCT02761096
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seoul, 05278, South Korea
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.
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:
Exclusion criteria
Participants with any of the following conditions will be excluded:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Kyunghee University Medical Center
Other
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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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