UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027349 |
|---|---|
| Receipt number | R000031340 |
| Scientific Title | Effect of rehabilitation for patients with tension type headache |
| Date of disclosure of the study information | 2017/05/24 |
| Last modified on | 2017/05/15 20:41:23 |
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Basic information
Public title
Effect of rehabilitation for patients with tension type headache
Acronym
Rehabilitation for tension type headache
Scientific Title
Effect of rehabilitation for patients with tension type headache
Scientific Title:Acronym
Rehabilitation for tension type headache
Region
| Japan |
Condition
Condition
Tension type headache
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study was to examine efficacy of rehabilitation compared to drug therapy for tension the headache after a 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Headache Impact Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rehabilitation 12 weeks
Interventions/Control_2
Drug therapy 12 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with tension type headache
Key exclusion criteria
Psychiatric disorders
Other structural problem
During pregnancy or with possibility of pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman's University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133648
t-nishi@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman's University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133648
Homepage URL
t-nishi@konan-wu.ac.jp
Sponsor or person
Institute
Konan Woman's University
Institute
Department
Personal name
Funding Source
Organization
No
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
Address
Tel
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
| 2017 | Year | 05 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031340
| 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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| Registered date | File name |
