Unique ID issued by UMIN | UMIN000049717 |
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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 | 2022/12/07 16:53:53 |
Randomized controlled trial of the combined effects of a pelvic belt and acupuncture on postpartum low back pain
Effects of a pelvic belt and acupuncture on postpartum low back pain
Randomized controlled trial of wearing a pelvic belt versus wearing a pelvic belt with acupuncture for postpartum low back pain
Effects of wearing a pelvic belt and acupuncture on postpartum low back pain in a randomized controlled trial
Japan |
postpartum low back pain
Obstetrics and Gynecology |
Others
NO
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.
Efficacy
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.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Other |
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.
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.
21 | years-old | <= |
42 | years-old | >= |
Female
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.
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.
72
1st name | Shunji |
Middle name | |
Last name | Sakaguchi |
Kansai University of Health Sciences
Graduate school
5900482
2-11-1 wakaba, Kumatori-cho, Sennan-gun, Osaka
0724538409
sakaguti@kansai.ac.jp
1st name | Shunjji |
Middle name | |
Last name | Sakaguchi |
Kansai University of Health Sciences
Graduate school
5900482
2-11-1 wakaba, Kumatori-cho, Sennan-gun, Osaka
0724538409
sakaguti@kansai.ac.jp
Kansai University of Health Sciences
Osaka Acupuncture Moxibustion Massage Association
Other
Kansai University of Health Sciences
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka
0724538251
sakaguti@kansai.ac.jp
NO
2022 | Year | 12 | Month | 07 | Day |
Unpublished
Enrolling by invitation
2022 | Year | 09 | Month | 01 | Day |
2022 | Year | 11 | Month | 10 | Day |
2022 | Year | 12 | Month | 20 | Day |
2024 | Year | 03 | Month | 31 | Day |
2022 | Year | 12 | Month | 07 | Day |
2022 | Year | 12 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056628
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