An interventional study of acupuncture and conventional treatment in Unruptured Cerebral Aneurysm, Hemifacial Spasm and Brain Tumor, sponsored by Kyunghee University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Kyunghee University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.
This study's enrollment of 44 is below the median of 61 across 11 interventional studies indexed under Hemifacial Spasm.
Browse Hemifacial Spasm studies →Kyunghee University Medical Center is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: 2 days after surgery
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.
Time frame: within 48 h before the surgery, 4 days after surgery and 7 days after surgery
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.
Time frame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum TNF-α
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
Serum IL-1β
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
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.
Time frame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
fever
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. Body temperature will be measured at 6:00, 10:00, 18:00, and 22:00 every day.
use of additional antibiotics
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
infection sign
Infections such as pneumonia or urinary tract infections will be recorded on the case report form.
Time frame: During the post operation day to 7 days after operation day,
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Kyunghee University Medical Center