Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
Completed · Not applicable
Conditions studied: Lower Back Pain, Lower Back Pain Chronic, Acute Low Back Pain
In brief
The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product. The main question this study aims to answer is: • Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain. Participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.
Key facts
- Study ID
- NCT06749912
- Run by
- State University of New York at Buffalo
- People needed
- 153
- Starts
- 2024-12-02
- Expected to finish
- 2025-05-23
- Last updated by the study team
- 2025-08-13
Who can join
Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 20 - 65
- Males and Females (50-50 split or close)
- Range of ethnicities
- Range of BMIs
You may not qualify if…
- 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 it is running
- University at Buffalo — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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