UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Transcultural reliability and validity of Japanese-language version of pelvic girdle questionnaire
Title of the study (Brief title)	Transcultural reliability and validity of Japanese-language version of pelvic girdle questionnaire
Region	Japan

Condition
Condition	pregnant and postpartum women
Classification by specialty	Obsterics and gynecology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to develop Japanese version of the pelvic girdle questionnaire and to clarify if a Japanese version of the PGQ was as valid the same as the original version.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pelvic girdle questionnaire, ODI, DRI, FEABQ, NRS, SF-36, sacroiliac joint sortieing,
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	40 years-old >=
Gender	Female
Key inclusion criteria	pregnancy postpartum women within 1 year after child delivery suffering form pelvic girdle pain
Key exclusion criteria	cesarean section health problems excepting pelvic girdle pain difficulty in daily living communication disorders mental and physical disabilities were excluded no pelvic girdle pain
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuyohi Gamada
Organization	Hiroshima international University
Division name	Graduate School of Medical Technology and Health Welfare Sciences
Address	555-36 kurosegakuendai higashihiroshima hiroshima Japan
TEL	0823704510
Email	kazgamada@ortho-pt.com

Public contact
Name of contact person	Asuka Sakamoto
Organization	Seirei Christopher University
Division name	Department of physical therapy, school of rehabilitation sciences
Address	3453 Mikatahara Kita-ku Hamamatsu Shizuoka
TEL	053534391998
Homepage URL
Email	asuka-s@seirei.ac.jp

Sponsor
Institute	Hiroshima International University
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 25 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	Cross cultural adaptation study cross sectional study

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2018 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035380