UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058622 |
|---|---|
| Receipt number | R000067007 |
| Scientific Title | The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/28 20:39:51 |
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Basic information
Public title
The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial
Acronym
The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial
Scientific Title
The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial
Scientific Title:Acronym
The effects of an exercise programme and pelvic belt use on pain and functional impairment in women with pregnancy-related low back and pelvic girdle pain: A randomised controlled trial
Region
| Japan |
Condition
Condition
Pregnancy-related low back pain and pelvic girdle pain
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of an exercise programme and pelvic belt use in women with pregnancy-related low back and pelvic girdle pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oswestry Disability Index (ODI) scores at 1, 3, and 6 months postpartum
Key secondary outcomes
1. Pain intensity assessed using the Numerical Rating Scale (NRS), and fear-avoidance beliefs assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ)
2. Active Straight Leg Raising (ASLR) test scores
3. Questionnaire survey on willingness for future pregnancy
4. Questionnaire survey on willingness to return to work and planned timing of return
5. Urinary function assessed using the Urogenital Distress Inventory-6 (UDI-6) and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
An exercise programme delivered via instructional video
Interventions/Control_2
An exercise programme delivered via instructional video plus pelvic belt use
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
1. Within one week postpartum and experiencing pregnancy-related low back and pelvic girdle pain
2. Not wearing a pelvic belt at the time of study enrolment and not planning to wear one, or currently wearing a pelvic belt but willing to switch to the study-provided belt if allocated to the exercise programme plus pelvic belt group
Key exclusion criteria
1. Individuals unable to participate in exercise therapy
2. Individuals with hypersensitivity to pelvic belts
3. Individuals with a history of lumbar or pelvic fracture or surgery
4. Individuals who underwent postpartum hysterectomy or uterine artery embolisation
5. Individuals with comorbid psychiatric disorders
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | keiichi |
| Middle name | |
| Last name | Oishi |
Organization
Okayama City Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
700-8557
Address
3-20-1 Kitanagase, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-737-3000
pkgy10rd+work@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Oishi |
Organization
Okayama City Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
700-8557
Address
3-20-1 Kitanagase, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-737-3000
Homepage URL
pkgy10rd+work@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation, Okayama Prefectural Industrial Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of the Medical Ethics Committee, Okayama City Hospital
Address
3-20-1 Kitanagase, Kita-ku, Okayama-shi, Okayama, Japan
Tel
086-737-3000
shiminbyouin_soumuka@okayama-gmc.or.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
| 2025 | Year | 07 | Month | 28 | 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
| 2025 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067007
