UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041376 |
|---|---|
| Receipt number | R000047237 |
| Scientific Title | Characteristics of the subjects of headache classroom in our hospital -Comparison between headache classroom subjects and patients treated with medication only- |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/10 14:03:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Characteristics of the subjects of headache classroom in our hospital
-Comparison between headache classroom subjects and patients treated with medication only-
Acronym
Characteristics of the subjects of headache classroom in our hospital
-Comparison between headache classroom subjects and patients treated with medication only-
Scientific Title
Characteristics of the subjects of headache classroom in our hospital
-Comparison between headache classroom subjects and patients treated with medication only-
Scientific Title:Acronym
Characteristics of the subjects of headache classroom in our hospital
-Comparison between headache classroom subjects and patients treated with medication only-
Region
| Japan |
Condition
Condition
Those diagnosed with tension-type headache
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective study of who was the subject of the headache classroom
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigated the following from the headache questionnaire at the first visit.
Survey item
1.Headache impact on life: Headache Impact Test-6 (HIT-6)
2.Degree of difficulty in work/sleep: Neck Disability Index (NDI)
3.Headache intensity: Numeric Rating Scale(NRS)
4.Number of headache days within the last 2 weeks: 0-14 days
2. Survey the following from general medical record information
Survey item
1.Age
2.Gender
3.Disease duration: less than 1 month, 1 month or more-less than 3 months, 3 months or more
4.Medication status: Medication is provided, medication is changed at least once, and no medication is provided.
5.Number of visits: Number of visits from the first visit to the end of the visit
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Those diagnosed with tension-type headache
Key exclusion criteria
Patients with mental or neurological disorders and those with a past history
A person who has an organic disease other than headache that affects daily activities.
Those who are pregnant or who may be pregnant
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Asami |
| Middle name | |
| Last name | Nitta |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Nitta |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
https://kawaguchi-ns.com
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Koriencho, Hirakata City, Osaka
Tel
0728351010
Kawaguchi Neurosurgery Rehabilitation Clinic
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
| 2020 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Extract retrospectively from medical records and records
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047237
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
