Randomized controlled trial of the combined effects of a pelvic belt and acupuncture on postpartum low back pai
Not Applicable
Recruiting
- Conditions
- postpartum low back pain
- Registration Number
- JPRN-UMIN000049717
- Lead Sponsor
- Kansai University of Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.