UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033952 |
|---|---|
| Receipt number | 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 22:29:16 |
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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
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
nao413m@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038728
