UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061483 |
|---|---|
| Receipt number | R000070265 |
| Scientific Title | Musculoskeletal Risk Factors for Pregnancy-Related Pelvic Girdle Pain: A Prospective Cohort Study |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/07 17:51:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Musculoskeletal Risk Factors for Pregnancy-Related Pelvic Girdle Pain: A Prospective Cohort Study
Acronym
Musculoskeletal Risk Factors for Pregnancy-Related Pelvic Girdle Pain: A Prospective Cohort Study
Scientific Title
Musculoskeletal Risk Factors for Pregnancy-Related Pelvic Girdle Pain: A Prospective Cohort Study
Scientific Title:Acronym
Musculoskeletal Risk Factors for Pregnancy-Related Pelvic Girdle Pain: A Prospective Cohort Study
Region
| Japan |
Condition
Condition
pregnancy-related pelvic girdle pain
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to longitudinally track changes in inner unit function, posture, and movement patterns associated with the progression of pregnancy, and to clarify their relationship with the onset of pre- and postpartum pelvic girdle pain. By doing so, we aim to identify physical risks before symptoms become manifest and to provide a basis for considering individualized physical therapy at the most effective timing.
Basic objectives2
Others
Basic objectives -Others
Risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment using the Visual Analogue Scale (VAS)
Key secondary outcomes
Functional disability level assessed by the Japanese-Language version of the Pelvic Girdle Questionnaire (PGQ-J)
Muscle function evaluation using ultrasonography (muscle thickening fraction of the diaphragm, transversus abdominis, and multifidus; bladder base elevation and anorectal angle of the pelvic floor muscles)
Postural and movement evaluation using SPLYZA Motion (joint angles during standing and gait)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Primiparous women aged 20 years or older, Receiving regular prenatal checkups, Having obtained permission from their obstetrician (attending physician)
Key exclusion criteria
Participants on prescribed bed rest (e.g., threatened premature labor), Abnormal pregnancy (e.g., placenta previa, ectopic pregnancy), Multiple pregnancy, Pregnancy complications (e.g., hypertensive disorders of pregnancy, gestational diabetes mellitus), History of trauma, tumor, or infection in the lumbar region, History of surgery for orthopedic conditions (spine, pelvis, or hip joint) or gynecological disorders
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Yokoi |
Organization
Josai International University
Division name
Graduate School of Health Sciences
Zip code
283-0002
Address
1 Gumyo, Togane-shi, Chiba
TEL
0475-53-2444
yokoi@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sato |
Organization
Josai International University
Division name
Graduate School of Health Sciences
Zip code
283-0002
Address
1 Gumyo, Togane-shi, Chiba
TEL
0475-55-8800
Homepage URL
mh25-003@jiu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
Josai International University
Address
1 Gumyo, Togane-shi, Chiba
Tel
0475-55-8800
yokoi@jiu.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
| 2026 | Year | 05 | Month | 08 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective cohort study aimed at identifying physical risk factors associated with pregnancy-related pelvic girdle pain (PPGP). The study will involve 57 pregnant and postpartum women visiting Total Health Clinic. Assessments will be conducted longitudinally at five time points: 12, 20, 28, and 36 weeks of gestation, and 1 month postpartum.
The primary outcomes are pain intensity (VAS) and functional disability (PGQ-J). Secondary outcomes include the evaluation of inner unit muscle function (diaphragm, transversus abdominis, multifidus, and pelvic floor muscles) using ultrasonography, and postural and movement analysis using SPLYZA Motion.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070265
