UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051313 |
|---|---|
| Receipt number | R000058530 |
| Scientific Title | Effects of physical changes during pregnancy and one year after childbirth on low back pain. |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/06/10 12:01:50 |
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Basic information
Public title
Effects of physical changes before and after childbirth on low back pain.
Acronym
Effects of physical changes before and after childbirth on low back pain.
Scientific Title
Effects of physical changes during pregnancy and one year after childbirth on low back pain.
Scientific Title:Acronym
Effects of physical changes during pregnancy and one year after childbirth on low back pain.
Region
| Japan |
Condition
Condition
pregnant woman and postpartum woman.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of physical changes on low back pain during pregnancy and one year after childbirth.
Basic objectives2
Others
Basic objectives -Others
By tracking changes in the presence or absence of low back pain in pregnant women over time, we believe that interventions for low back pain prevention can be obtained.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation items are back, presence or absence of pain, low back pain VAS, delivery method.
The timing was 32 weeks pregnant, 1 month postpartum, 4 months postpartum, 7 months postpartum, 10 months postpartum, and 12 months postpartum, a total of 6 times.
Key secondary outcomes
Evaluation items are body composition analysis, center of gravity sway, and exercise habits.
The timing was 32 weeks of pregnancy, 1 month after childbirth, 4 months after childbirth, 7 months after childbirth, 10 months after childbirth, and 12 months after childbirth, a total of 6 times.
Base
Study type
Observational
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
| 28 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
There are 4 pregnant women who are scheduled to give birth in August 2023 who were recruited by the research director and research director, and there is a possibility of conducting research.
Key exclusion criteria
Those whose activities are restricted by a doctor during pregnancy
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Wada |
Organization
International University of Health and Welfare
Division name
Faculty of Health Sciences, Odawara
Zip code
2508588
Address
1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture
TEL
0465-21-6724
miyuki-wada@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Wada |
Organization
International University of Health and Welfare
Division name
Faculty of Health Sciences, Odawara
Zip code
2508588
Address
1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture
TEL
0465-21-6724
Homepage URL
miyuki-wada@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture
Tel
0464-21-6724
miyuki-wada@iuhw.ac.jp
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
| 2023 | Year | 08 | Month | 01 | 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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is carried out for subjects from before childbirth to after childbirth.
Basic information such as age, height, weight, expected date of delivery, date of delivery, and method of delivery will be collected.
In addition, body composition analysis (InBody270 manufactured by InBody) is used to check muscle mass and fat mass.
The presence or absence of low back pain and pain at rest and during exercise are investigated using Visual Analog Scale: VAS, and the curvature of the spine is confirmed with a flexible curve ruler (manufactured by Shinwa Measurement Co., Ltd. 74853).
Internationally standardized physical activity questionnaire (IPAQ Short Ver. Usual) regarding exercise habits, exercise content will be asked.
In order to check the movement control in the pelvis at rest and during exercise, a stabilometer (balance coder BW-6000 manufactured by ANIMA) was used. CrossTest is measured as a standing and dynamic index.
The CrossTest is performed in the order of front, rear, right, and left, after standing still for 2 seconds, moving forward over 3 seconds, and returning to the center over 3 seconds.
Management information
Registered date
| 2023 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058530
