Unruptured Cerebral AneurysmNCT02761096
Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
A study testing acupuncture and conventional treatment in people with Unruptured Cerebral Aneurysm and Hemifacial Spasm, run by Kyunghee University Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor
- What is being tested?
- acupuncture and conventional treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria in order to be included:
- planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
- age > 18 years;
- acupuncture treatment that can start within 48 h after craniotomy;
- voluntary participation and provision of signed informed consent form.
Who cannot join
- Participants with any of the following conditions will be excluded:
- serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
- a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
- craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
- 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;
- a history of surgery at the same site;
- emergency surgery; or
- a severe medical disease, e.g. congestive heart failure, chronic renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor
- Being tested
- acupuncture, conventional treatment
- Medical subject headings
- Hemifacial Spasm, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
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.
conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: acupuncture; Other: conventional treatment |
| 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. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days after surgery
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the post operation day to 7 days after operation day,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University
- Responsible party
- Principal investigator, Seong-Uk Park, Kyunghee University Medical Center
- Investigators
- Seong-Uk Park, KMD, PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761096
- Sponsor's protocol ID
- 20152152
- Status last verified
- Feb 2019
- First submitted
- 27 Apr 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28069040
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Inflammation and Immune Function After Craniotomy
- ClinicalTrials.gov ID
- NCT02761096
- Acronym / sponsor ID
- 20152152
- Conditions
- Unruptured Cerebral Aneurysm, Hemifacial Spasm, Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Kyunghee University
- Study start
- Apr 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: acupuncture, Other: conventional treatmentThe 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 | Other: conventional treatmentThe subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- planning to undergo regular craniotomy performed for an unruptured aneurysm, facial spasm, or brain tumor;
- age > 18 years;
- acupuncture treatment that can start within 48 h after craniotomy;
- voluntary participation and provision of signed informed consent form.
Key exclusion criteria (8 listed)
- serum C-reactive protein (CRP) level ≥ 1.0 mg/dl before craniotomy;
- a condition other than an unruptured aneurysm, facial spasm, or brain tumor as an indication for craniotomy;
- craniotomy performed for infectious brain diseases such as brain abscess or subdural empyema;
- 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;
- a history of surgery at the same site;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture, 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. | Device | Study group |
| conventional treatmentThe 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. | Other | Control group, Study group |
Primary outcome
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.
8 secondary outcomes
Serum CRP
Time frame: within 48 h before the surgery, 4 days after surgery and 7 days after surgery
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
Serum TNF-α
Time frame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum IL-1β
Time frame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
Serum IL-6
Time frame: within 48 h before the surgery, 2 days after surgery, 4 days after surgery and 7 days after surgery
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.
use of additional antibiotics
Time frame: During the post operation day to 7 days after operation day
infection sign
Time frame: During the post operation day to 7 days after operation day,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 28069040Cho 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.
- Individual participant dataSharing planned: No
Related trials for Unruptured Cerebral Aneurysm
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Aneurysm, Aneurysm, Intracranial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong-Uk Park, KMD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and conventional treatment in people with Unruptured Cerebral Aneurysm and Hemifacial Spasm, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP (time frame: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.