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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033952
Receipt No. R000038728
Scientific Title Effectiveness of group intervention and self-management for low back and pain after delivery
Date of disclosure of the study information 2018/08/30
Last modified on 2018/08/29

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Basic information
Public title Effectiveness of group intervention and self-management for low back and pain after delivery
Acronym Effectiveness of group intervention and self-management for low back and pain after delivery
Scientific Title Effectiveness of group intervention and self-management for low back and pain after delivery
Scientific Title:Acronym 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
1st name
Middle name
Last name Rei Ono
Organization Kobe University Graduate School of Health Sciences
Division name Department of Public Health
Zip code
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
1st name
Middle name
Last name Naoka Matsuda
Organization Kobe University Graduate School of Health Sciences
Division name Graduate School of Health Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 02 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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