Using a lumbar wrap to reduce lower back pain and improve quality of life
Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
This study is testing whether a lumbar wrap can help adults aged 20 to 65 with lower back pain feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06749912 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a lumbar wrap device in alleviating lower back pain and enhancing physical function and quality of life in adults aged 20 to 65. Participants will engage in a counterbalanced cross-over design, where they will alternate between using the wrap for 20 minutes daily and a control period without the device over four weeks. Daily surveys will be administered to track symptoms and compliance, while pre-, mid-, and post-surveys will gather additional data on device efficacy and participant health metrics.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 65 experiencing either acute or chronic lower back pain.
Not a fit: Patients with conditions requiring surgical intervention for lower back pain or those currently undergoing rehabilitation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive method for managing lower back pain, improving patients' daily functioning and overall quality of life.
How similar studies have performed: While similar approaches have been explored, this specific use of a lumbar wrap device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 20 - 65 * Males and Females (50-50 split or close) * Range of ethnicities * Range of BMIs Exclusion Criteria: * Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention * Those currently undergoing rehabilitation treatment for LBP * Those with other diagnosed conditions that may preclude them from safely participating * Pregnant women * Waist less than 26" or greater than 66" due to device limitations
Where this trial is running
Buffalo, New York
- University at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kyle J Kelleran, PhD — University at Buffalo
- Study coordinator: Kyle J Kelleran, PhD
- Email: kjk9@buffalo.edu
- Phone: 716-645-9724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.