UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043893 |
|---|---|
| Receipt number | R000050126 |
| Scientific Title | The objective assessment tools of the effect of acupuncture for migraine: Advanced-MRI study |
| Date of disclosure of the study information | 2021/04/12 |
| Last modified on | 2024/04/15 08:48:30 |
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Basic information
Public title
The objective assessment tools of the effect of acupuncture for migraine: Advanced-MRI study
Acronym
The objective assessment tools of the effect of acupuncture for migraine
Scientific Title
The objective assessment tools of the effect of acupuncture for migraine: Advanced-MRI study
Scientific Title:Acronym
The objective assessment tools of the effect of acupuncture for migraine
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using DTI and fMRI imaged before and after acupuncture, we examine the structural and functional changes in the brain of pain-related regions in the acupuncture group and the sham acupuncture group based on Traditional Chinese Medicine, as well as the treatment effect index of acupuncture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Headache Impact Test (HIT-6): baseline and after 3months.
Key secondary outcomes
Numerical rating scale (NRS)
Self-rating depression scale (SDS)
Diffusion tensor imaging (DTI)
Resting state functional MRI (rsfMRI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupuncture
Interventions/Control_2
Sham acupuncture
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects must satisfy the following conditions for inclusion:
1. Migraine
2. Understand the explanation of the experiment and express consent.
3. patients could be treated with acupuncture therapy once a week for three months.
4. no history of other neurological disease
5. no other type of primary or secondary headache
6. over three years since the diagnosis of migraine
7. no another acupuncture treatment during the study period
Key exclusion criteria
1. Neurological deficit and/or intracranial abnormality.
2. another acupuncture treatment during study period
3. Pregnant
4. Perticipate another clinical trials
5. prophylactic medications added and/or changed during the study period."
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shibata |
Organization
University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Division name
Department of Neurosurgery, Headache Clinic
Zip code
3100015
Address
3-2-7 miyamachi, Mito, Ibaraki
TEL
029-231-2371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Tsukuba university of technology
Division name
Faculty of Health Sciences
Zip code
3058521
Address
4-12-7, Kasuga, Tsukuba, Ibaraki
TEL
0298589593
Homepage URL
suishiyama@ad.tsukuba-tech.ac.jp
Sponsor or person
Institute
University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba university of technology
Address
4-12-7, Kasuga, Tsukuba, Ibaraki
Tel
0298589593
suishiyama@ad.tsukuba-tech.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050126
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
