UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of group intervention and self-management for low back and pain after delivery
Title of the study (Brief title)	Effectiveness of group intervention and self-management for low back and pain after delivery
Region	Japan

Condition
Condition	Postpartum women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine effectiveness of group intervention and self-management for low back and pain after delivery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Low and pelvic pain(4 months after childbirth and 10 months after childbirth)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Group intervention at once (education, stretching, and exercise) and self-management
Interventions/Control_2	No treatment
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Postpartum women who had low and pelvic pain during pregnancy and were eligible to participate in this study
Key exclusion criteria	systemic locomotor system disease, diagnosis of spinal problems in the previous 2 months, history of spinal, pelvic, or femur fracture or surgery, or neoplasm, and pregnancy
Target sample size	28

Research contact person
Name of lead principal investigator	Rei Ono
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Public Health
Address	7-10-2, Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL	81-78-796-4515
Email	ono@phoenix.kobe-u.ac.jp

Public contact
Name of contact person	Naoka Matsuda
Organization	Kobe University Graduate School of Health Sciences
Division name	Graduate School of Health Sciences
Address	7-10-2, Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL	81-78-796-4526
Homepage URL
Email	nao413m@gmail.com

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization	Kobe University Research Promotion Division
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	丹南健康福祉センター（兵庫県） Tannan Health and Welfare Center

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 02 Day
Anticipated trial start date	2018 Year 08 Month 30 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	2018 Year 08 Month 29 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038728