UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of rehabilitation for patients with tension type headache
Title of the study (Brief title)	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	Tomohiko Nishigami
Organization	Konan Woman's University
Division name	Department of Nursing and Physical Therapy
Address	6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL	0784133648
Email	t-nishi@konan-wu.ac.jp

Public contact
Name of contact person	Tomohiko Nishigami
Organization	Konan Woman's University
Division name	Department of Nursing and Physical Therapy
Address	6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL	0784133648
Homepage URL
Email	t-nishi@konan-wu.ac.jp

Sponsor
Institute	Konan Woman's University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031340