UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051138 |
|---|---|
| Receipt number | R000058320 |
| Scientific Title | Verification of effectiveness in preventing low back and pelvic pain during the perinatal period |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 14:14:25 |
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Basic information
Public title
Verification of effectiveness in preventing low back and pelvic pain during the perinatal period
Acronym
Verification of effectiveness in preventing low back and pelvic pain during the perinatal period
Scientific Title
Verification of effectiveness in preventing low back and pelvic pain during the perinatal period
Scientific Title:Acronym
Verification of effectiveness in preventing low back and pelvic pain during the perinatal period
Region
| Japan |
Condition
Condition
pregnant woman
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of exercise therapy intervention on postpartum low back and pelvic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Location of pain, SF-36, pelvic girdle questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Motor control exercises based on yoga and Pilates
Interventions/Control_2
Not exercised
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women scheduled to give birth at the Japanese Red Cross Medical Center
Key exclusion criteria
Those who are unable to collect data appropriately due to significant gynecological or neurological diseases.
Examples of diseases: Serious cardiac disease, respiratory disease, cervical atresia, persistent genital bleeding, placenta previa, placenta previa, low placenta previa, premature water breakage, impending miscarriage/premature delivery, gestational hypertension, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kaneoka |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1, Higashifushimi, Nishitokyo, Tokyo,
TEL
042-452-7156
kaneoka@waseda.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Morito |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1, Higashifushimi, Nishitokyo, Tokyo
TEL
08041683115
Homepage URL
mori_tsuyo88@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Tsuyoshi Morito
Funding Source
Organization
Sports Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Management Division, Research Promotion Department, Waseda University
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
日本赤十字社医療センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 23 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058320
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
