UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049717 |
|---|---|
| Receipt number | R000056628 |
| Scientific Title | Randomized controlled trial of wearing a pelvic belt versus wearing a pelvic belt with acupuncture for postpartum low back pain |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2024/06/14 09:01:26 |
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Basic information
Public title
Randomized controlled trial of the combined effects of a pelvic belt and acupuncture on postpartum low back pain
Acronym
Effects of a pelvic belt and acupuncture on postpartum low back pain
Scientific Title
Randomized controlled trial of wearing a pelvic belt versus wearing a pelvic belt with acupuncture for postpartum low back pain
Scientific Title:Acronym
Effects of wearing a pelvic belt and acupuncture on postpartum low back pain in a randomized controlled trial
Region
| Japan |
Condition
Condition
postpartum low back pain
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on a survey of postpartum back pain, a randomized controlled trial will examine the effects of combining acupuncture treatment with pelvic belt wear as usual care during the postpartum hospitalization period on the degree of back pain up to 2 weeks postpartum and the degree of difficulty in daily life caused by it, using the pelvic belt wear as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the Functional Assessment Questions for Patients with Low Back Pain, which will be administered four times to the Visual Analogue Scale and 30 questions (5-item method): at enrollment as a subject, on the second postpartum day, on the fifth postpartum day (at discharge), and at the two-week postpartum checkup.
Key secondary outcomes
The secondary outcome will be a 4-item scale of activities during the postpartum period developed by Kusumi and colleagues, administered four times: at subject enrollment (10 items), 2 days after delivery (2 types, 11 items in total), 5 days postpartum (at discharge) (2 types, 11 items in total), and at the 2-week postpartum checkup (8 items). In addition, the degree of pain is rated on an 11-point scale using the Numerical Rating Scale.
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
| Other |
Interventions/Control_1
Acupuncture treatment for wearing the designated pelvic belt. Based on single-use acupuncture needles (40 mm long, 0.12 mm in diameter), 4 acupuncture points (BL25, BL52, attachment points of the gluteus medius, gluteus maximus, or pisiform muscle, etc.) were selected from the lumbar region to improve back pain and to restore the postnatal physical condition, and 2 to 3 other points were also selected for minor problems after delivery. (2 to 3 acupuncture points) are also used for minor postpartum problems. The intervention period will be 5 days during both hospitalizations (discharge on the afternoon of the 5th day). In the combined group, in addition to wearing a pelvic belt from after delivery, acupuncture treatment will be provided based on medical interviews and physical examination twice on the 2nd and 4th days postpartum.
Interventions/Control_2
The single group will wear the pelvic belt only, but as in the combined group, medical interviews and physical examinations will be conducted on the second and fourth postpartum days.
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
| 21 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
The subjects will be 72 pregnant women (36 in 2022 and 36 in 2023) (ages 21-42) who will visit Taniguchi Hospital (Izumisano, Osaka) and complain of back pain at their 36-week checkup.
Key exclusion criteria
Even if consent is obtained at the time of checkup, patients will be asked to withdraw if they have had a cesarean delivery, if they have gestational hypertension or unstable blood pressure during pregnancy and postpartum period, if their back pain has disappeared after delivery, or if the doctor deems them otherwise unsuitable.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate school
Zip code
5900482
Address
2-11-1 wakaba, Kumatori-cho, Sennan-gun, Osaka
TEL
0724538409
sakaguti@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Shunjji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate school
Zip code
5900482
Address
2-11-1 wakaba, Kumatori-cho, Sennan-gun, Osaka
TEL
0724538409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka Acupuncture Moxibustion Massage Association
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
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka
Tel
0724538251
sakaguti@kansai.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 | 12 | Month | 07 | 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
74
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056628
