UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046905 |
|---|---|
| Receipt number | R000053520 |
| Scientific Title | Investigation of the effect of pelvic floor muscle training using hip joint exercises on low back pain in postpartum women |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/08/17 10:21:43 |
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Basic information
Public title
Investigation of the effect of pelvic floor muscle training using hip joint exercises on low back pain in postpartum women
Acronym
Investigation of the effect of pelvic floor muscle training using hip joint exercises on low back pain
Scientific Title
Investigation of the effect of pelvic floor muscle training using hip joint exercises on low back pain in postpartum women
Scientific Title:Acronym
Investigation of the effect of pelvic floor muscle training using hip joint exercises on low back pain
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of pelvic floor muscle training using hip joint exercises on low back pain in postpartum women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activity limitation due to low back pain (ODI) (pre, post 6w)
Key secondary outcomes
Bladder base elevation volume(ultrasound imaging)
Continuous bladder base elevation time(ultrasound imaging)
Vertical distance between pubococcygeal line and bladder neck/endocervical opening (MRI)
Lumbar spine and hip angle during hip extension (accelerometer)
Degree of low back pain (NRS)
Pelvic floor muscle function (Female Pelvic Floor Deprivation Questionnaire)
Adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Pelvic floor exercises using hip muscle activity(2 times/day, 3 times/week for 6 weeks)
Interventions/Control_2
Normal pelvic floor muscle exercises(2 times/day, 3 times/week for 6 weeks)
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Women within 6 weeks to 1 year after childbirth with low back pain that lasts for more than 3 months
Key exclusion criteria
Those who have a history of specific orthopedic diseases or surgery related to the spine or lower extremities, pregnant women, people with pain other than in the lumbar region that interferes with daily life, people with contraindications to MRI
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1 Taiyogaoka, Kanazawa City, Ishikawa Prefecture, Japan
TEL
0762291161
ry_miyachi@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1 Taiyogaoka, Kanazawa City, Ishikawa Prefecture, Japan
TEL
0762291161
Homepage URL
ry_miyachi@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
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
Hokuriku University Research Support Division
Address
1 Taiyogaoka, Kanazawa City, Ishikawa Prefecture, Japan
Tel
076-229-6007
research@hokuriku-u.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
| 2022 | Year | 04 | 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
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
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053520
