UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042256 |
|---|---|
| Receipt number | R000046656 |
| Scientific Title | Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2026/01/27 00:23:07 |
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Basic information
Public title
Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain
Acronym
Effects of acupuncture on postpartum low back pain
Scientific Title
Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain
Scientific Title:Acronym
Effects of acupuncture on postpartum Low back pain
Region
| Japan |
Condition
Condition
Postnatal low back pain
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of acupuncture on postpartum low back pain with usual care (pelvic belt) and usual care in a randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
100 mm Visual Analogue Scale (VAS)
Key secondary outcomes
Roland-Morris Disability Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture at least twice a day from 2 to 4 days after delivery
Interventions/Control_2
wearing a low back pain band.
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women with lumbago complaints at 36 weeks gestation
Key exclusion criteria
Those who have had a Caesarean delivery, those who have gestational hypertension and unstable blood pressure during pregnancy and after delivery
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | keiko |
| Middle name | |
| Last name | Tsujiuchi |
Organization
Serie Womens Health Care Acupuncture and moxibustion room
Division name
Clinical
Zip code
231-0063
Address
1-5-704 Hanasaki-cho Naka-ku Yokohama-shi, Kanagawa, Japan
TEL
0452629562
czw06225@nifty.com
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code
590-0433
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-8409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association Japan Hot Spring Climate Physics Society
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
Serie Womens Health Care Acupuncture and moxibustion room
Address
1-5-704 Hanasaki-cho Naka-ku Yokohama-shi, Kanagawa, Japan
Tel
0452625550
info@aerie89.com
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
医療法人定生会 谷口病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kampomed/72/4/72_341/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kampomed/72/4/72_341/_pdf/-char/ja
Number of participants that the trial has enrolled
22
Results
Out of 30 cases, 8 were excluded, and the groups of 11 each showed no significant differences in basic information. Using two days postpartum as a reference, there were no significant differences in VAS or RDQ at four days postpartum or one month postpartum; however, a 'moderate' effect size was observed on the VAS in the acupuncture combined group at four days postpartum, and on the RDQ in the pelvic belt wearing group at one month postpartum. No adverse events were observed in either group.
Results date posted
| 2026 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Among women who reported back pain in the late stages of pregnancy at an obstetric hospital and had no complications during delivery, participants were randomly assigned to a group wearing a pelvic belt or a group using a pelvic belt combined with acupuncture treatment.
Participant flow
Out of 30 cases, 8 were excluded, and there were no significant differences in basic information between the groups of 11.
Adverse events
No adverse events were observed in either group.
Outcome measures
The effects were evaluated using the Visual Analogue Scale (VAS) and the Japanese version of the Roland Morris Disability Questionnaire (RDQ), with self-administered responses collected 2 days, 4 days, and 1 month after childbirth.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046656
