UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048961 |
|---|---|
| Receipt number | R000055623 |
| Scientific Title | Association Between Excessive Weight Muscle Mass and Persistent Low Back and Pelvic Pain After Delivery |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2025/10/01 04:33:02 |
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Basic information
Public title
Association Between Excessive Weight Muscle Mass and Persistent Low Back and Pelvic Pain After Delivery
Acronym
Association Between Excessive Weight Muscle Mass and Persistent Low Back and Pelvic Pain After Delivery
Scientific Title
Association Between Excessive Weight Muscle Mass and Persistent Low Back and Pelvic Pain After Delivery
Scientific Title:Acronym
Association Between Excessive Weight Muscle Mass and Persistent Low Back and Pelvic Pain After Delivery
Region
| Japan |
Condition
Condition
pregnancy women
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the Association Between trunk muscle mass and Persistent Low Back and Pelvic Pain (LBPP) at a month After Delivery.
Basic objectives2
Others
Basic objectives -Others
To clarify the difference in Lifestyle habit between with and without pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
with or without low back and pelvic pain
Key secondary outcomes
muscle mass
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Single-pregnant women who have undergone antenatal checkups(After 35 weeks) at our clinic
Key exclusion criteria
1.Persons involved in traffic accidents
2.Delivery at another hospital
3.Those who do not agree
4.person with missing data
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | hayashikatsuhito2 |
| Middle name | |
| Last name | Hayashi |
Organization
Nagasaki Medical Center, department of Rehabilitation medicine
Division name
Department of Rehabilitation medicine
Zip code
856-8562
Address
2-1001-1 Kubara, Omura-shi, Nagasaki-ken
TEL
0957-52-3121
hanakatsu99@yahoo.co.jp
Public contact
Name of contact person
| 1st name | hayashikatsuhito2 |
| Middle name | |
| Last name | Hayashi |
Organization
Nagasaki Medical Center, department of Rehabilitation medicine
Division name
Department of Rehabilitation medicine
Zip code
856-8562
Address
2-1001-1 Kubara, Omura-shi, Nagasaki-ken
TEL
0957-52-3121
Homepage URL
hanakatsu99@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Medical Center, department of Rehabilitation medicine
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Medical Center, department of Rehabilitation medicine
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
Nagasaki Medical Center, department of Rehabilitation medicine
Address
2-1001-1 Kubara, Omura-shi, Nagasaki-ken
Tel
0957-52-3121
hanakatsu99@yahoo.co.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
| 2022 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000055623
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000055623
Number of participants that the trial has enrolled
690
Results
Although the absolute TMM was higher in women with pp-LBPP, the TMM-I did not differ significantly between groups . In the multivariate logistic regression analysis, four independent predictors of pp-LBPP were identified: older maternal age, primiparity, cesarean section, and absence of pre-pregnancy athletic activity. TMM-I was not independently associated with pp-LBPP.
Results date posted
| 2025 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pregnant women with self-reported LBPP at 35 weeks gestation were invited to participate. Inclusion criteria included age 20 years or older, and singleton pregnancy, and the presence of LBPP at enrollment. Exclusion criteria were a history of spinal disease, delivery at other facilities, incomplete clinical data, or absence from postpartum follow-up visits.
Participant flow
Among 690 screened women, 209 met inclusion criteria and completed follow-up. Of these, 101 women (48%) reported pp-LBPP at four months postpartum.
Adverse events
Not applicable.
Outcome measures
maternal age, parity, pre-pregnancy BMI, gestational weight gain, delivery mode, breastfeeding status, history of LBPP before pregnancy, history of athletic activity (participation in sports after age 20), and habitual pre-pregnancy exercise (defined as engaging in physical activity for at least 30 minutes, twice per week).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 10 | Month | 01 | Day |
Other
Other related information
none in particular
Management information
Registered date
| 2022 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055623
