UMIN-CTR Clinical Trial

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
Email	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
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047237