UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017253 |
|---|---|
| Receipt number | R000020017 |
| Scientific Title | Multicenter trial of craniocervical oscillating stimulation for chronic headaches |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/04/27 08:27:17 |
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Basic information
Public title
Multicenter trial of craniocervical oscillating stimulation for chronic headaches
Acronym
Physical therapy using by craniocervical oscillating stimulation for chronic headaches
Scientific Title
Multicenter trial of craniocervical oscillating stimulation for chronic headaches
Scientific Title:Acronym
Physical therapy using by craniocervical oscillating stimulation for chronic headaches
Region
| Japan |
Condition
Condition
chronic migrane
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy of craniocervical oscillating stimulation for chronic headaches
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of headaches
Key secondary outcomes
ADL, Intense of headaches, Depression, Anxiety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Physical therapy
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic migrane
Key exclusion criteria
Cervical disorders
Osteoporosis
Eruption of face and neck
Psychosis
Cognitive disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Munefumi |
| Middle name | |
| Last name | Hotta |
Organization
Hotta Clinic
Division name
Internal Medicine
Zip code
4228035
Address
1-4-7, Miyatake, Surugaku, Shizuoka, Japan
TEL
052-237-9877
nrh34193@nifty.com
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Imai Noboru |
Organization
Shizuoka Red Cross hospital
Division name
Neurology
Zip code
4220853
Address
8-2, Oitemachi, Aoiku, Shizuoka City, Japna
TEL
054-254-0853
Homepage URL
neurologyimai@gmail.com
Sponsor or person
Institute
Shizuoka Red Cross hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
Shizuoka Red Cross
Address
Shizuoka, aoi, outecyou8-2
Tel
054-254-0853
neurologyimai@gmail.com
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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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