UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057866 |
|---|---|
| Receipt number | R000066135 |
| Scientific Title | Effect of Exercise Instruction on Pain Reduction in Women with Pregnancy-Related Low Back and Pelvic Pain: A Prospective Cohort Study |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2026/02/07 11:47:58 |
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Basic information
Public title
Effect of Exercise Instruction on Pain Reduction in Women with Pregnancy-Related Low Back and Pelvic Pain: A Prospective Cohort Study
Acronym
Effect of Exercise Instruction on Pain Reduction in Women with Pregnancy-Related Low Back and Pelvic Pain: A Prospective Cohort Study
Scientific Title
Effect of Exercise Instruction on Pain Reduction in Women with Pregnancy-Related Low Back and Pelvic Pain: A Prospective Cohort Study
Scientific Title:Acronym
Effect of Exercise Instruction on Pain Reduction in Women with Pregnancy-Related Low Back and Pelvic Pain: A Prospective Cohort Study
Region
| Japan |
Condition
Condition
Pregnancy-Related Low Back and Pelvic Pain
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pain-reduction effects of exercise instruction by physical therapists and midwives, and of pelvic-belt application, in women with pregnancy-related low back and pelvic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oswestry Disability Index (ODI) scores at 5 days, 1 month, and 3 months postpartum.
Key secondary outcomes
NRS(Numerical Rating Scale)
FABQ-PA(Fear Avoidance Beliefs Questionnaire-Physical Activity)
P-FIBS-F (Frequency subscale of the Pain Frequency, Intensity, and Burden Scale):Only the frequency-related items of the Pain Frequency, Intensity, and Burden Scale were used.
WHOQOL-BREF-Q2
Physical findings:presence or absence of pubic symphysis tenderness, Active Straight Leg Raise (ASLR) test, and pelvic pain provocation tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Usual care plus informational materials on low back and pelvic pain
Interventions/Control_2
Usual care plus informational materials on low back and pelvic pain and individualized exercise instruction
Interventions/Control_3
Usual care plus informational materials on low back and pelvic pain, individualized exercise instruction, and pelvic belt application
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. Pregnant women at 28 weeks of gestation or later
2. Presence of low back pain or pelvic pain
3. Aged 18 years or older
Key exclusion criteria
1. Contraindications to exercise
2. History of lumbar spine or pelvic fracture or surgery
3. Hypersensitivity to the pelvic belt
4. Twin pregnancy
5. Requirement for postpartum hysterectomy or uterine artery embolization
6. Comorbid psychiatric disorder
Target sample size
123
Research contact person
Name of lead principal investigator
| 1st name | Masuyama |
| Middle name | |
| Last name | Hisashi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558, Japan
TEL
086-235-7320
pkgy10rd+work@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Oishi |
| Middle name | |
| Last name | Keiichi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558, Japan
TEL
086-235-7320
Homepage URL
pt5d6ygd@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Keiichi Oishi
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 Institutional Review Board, Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
| 2025 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/1471-0528.70171
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/1471-0528.70171
Number of participants that the trial has enrolled
127
Results
A total of 127 participants were enrolled; 107 completed follow-up. At 1 month postpartum, lower ODI scores were observed in the exercise group (mean difference 5.4; 95% CI 3.3 to 7.6), and similarly in the exercise plus belt group (mean difference 4.9; 95% CI 2.6 to 7.2), compared with the leaflet group. At 3 months postpartum, no clear between-group differences were observed.
Results date posted
| 2026 | Year | 02 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 29 | Day |
Baseline Characteristics
Demographic, obstetric, and clinical characteristics across the three study groups are presented for reference. Some numerical differences were observed in maternal age and delivery-related characteristics, including gestational age at delivery, mode of delivery, epidural analgesia use, degree of perineal laceration, and direction of caesarean skin incision.
Participant flow
A total of 228 pregnant women at 28 weeks or later gestation were assessed for eligibility across four participating sites. Of these, 101 were excluded: 80 did not report low back pain or pelvic girdle pain, and 21 withdrew. A total of 127 women with PLBP/PPGP were enrolled and allocated to one of three intervention groups according to site-level assignment. By 1 month postpartum, follow-up data were obtained for 119 participants. At 3 months postpartum, outcome data were available for 107 participants, who constituted the full analysis set.
Adverse events
No adverse events related to exercise instruction or pelvic belt use were reported.
Outcome measures
Oswestry Disability Index (ODI) scores at 5 days, 1 month, and 3 months postpartum.
NRS(Numerical Rating Scale)
FABQ-PA(Fear Avoidance Beliefs Questionnaire-Physical Activity)
P-FIBS-F (Frequency subscale of the Pain Frequency, Intensity, and Burden Scale):Only the frequency-related items of the Pain Frequency, Intensity, and Burden Scale were used.
WHOQOL-BREF-Q2
Physical findings:presence or absence of pubic symphysis tenderness, Active Straight Leg Raise (ASLR) test, and pelvic pain provocation tests
Plan to share IPD
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066135
