UMIN-ICDS Clinical Trial

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

pregnant woman and postpartum woman.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

miyuki-wada@iuhw.ac.jp

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

Email

miyuki-wada@iuhw.ac.jp

Institute

International University of Health and Welfare

Institute

Department

Personal name

Organization

International University of Health and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

International University of Health and Welfare

Address

1-2-25 Shiroyama, Odawara City, Kanagawa Prefecture

Tel

0464-21-6724

Email

miyuki-wada@iuhw.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000058530