Randomized controlled trial of the combined 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049717

Enrollment

Registered

2022-12-07

Start date

2022-12-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postpartum low back pain

Interventions

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 glut

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactShunjji Sakaguchi

Kansai University of Health Sciences Graduate school

sakaguti@kansai.ac.jp0724538409

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026