Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyunghee University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
|
| Control group | Other | The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum erythrocyte sedimentation rate (ESR) |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seong-Uk Park, KMD, PhD | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28069040 | Derived | Cho SY, Yang SB, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Park SU. Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial. Trials. 2017 Jan 10;18(1):10. doi: 10.1186/s13063-016-1712-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019569 | Hemifacial Spasm |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| 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. | 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. | 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. | 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. | 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. | 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. | During the post operation day to 7 days after operation day, |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |