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 | 2022/09/24 03:49:07 |
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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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
690
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
| 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
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular
Management information
Registered date
| 2022 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055623
