UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055362 |
|---|---|
| Receipt number | R000063092 |
| Scientific Title | Verification of the effect on physical therapy for lower back pain and pelvic girdle pain in pregnant and postpartum women |
| Date of disclosure of the study information | 2024/08/29 |
| Last modified on | 2025/02/28 09:35:55 |
* 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
Verification of the effect on physical therapy for lower back pain and pelvic girdle pain in pregnant and postpartum women
Acronym
Verification of the effect on physical therapy for lower back pain and pelvic girdle pain in pregnant and postpartum women
Scientific Title
Verification of the effect on physical therapy for lower back pain and pelvic girdle pain in pregnant and postpartum women
Scientific Title:Acronym
Verification of the effect on physical therapy for lower back pain and pelvic girdle pain in pregnant and postpartum women
Region
| Japan |
Condition
Condition
Pregnant women, Postpartum women
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of physical therapy intervention by activating inner unit functions such as transversus abdominis and pelvic floor muscles for lower back pain and pelvic girdle pain in pregnant and postpartum women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment (NRS, RDQ)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Physical therapy individual intervention for 30 minutes per session, self-exercise for 1 month
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Women from 16 weeks of pregnancy to 1 month postpartum with lumbar back pain or pelvic girdle pain without any pregnancy or postpartum problems.
Key exclusion criteria
1. Multiple pregnancies
2. Subjects who already exercise regularly
3. Subjects who are diagnosed with severe perinatal or postpartum depression
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuyo |
| Middle name | |
| Last name | Sunaga |
Organization
Saitama Prefectural University
Division name
Faculty of Health and Social Service
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-Shi, Saitama
TEL
048-973-4310
sunaga-yasuyo@spu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyo |
| Middle name | |
| Last name | Sunaga |
Organization
Saitama Prefectural University
Division name
Faculty of Health and Social Service
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-Shi, Saitama
TEL
048-973-4310
Homepage URL
sunaga-yasuyo@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Physical Therapy
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
Research Ethics Committee in Saitama Prefectural University
Address
Sannomiya 820, Koshigaya-Shi, Saitama
Tel
0489734120
rinri@spu.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
よしかた産婦人科（神奈川県），東京北医療センター（東京都），佐々木産婦人科（広島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063092
