Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
CompletedNot applicableNCT06749912
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
- Conditions
- Lower Back Pain
- Lower Back Pain Chronic
- Acute Low Back Pain
- Interventions
- Device: Low back pain wrap
- Sponsor
- State University of New York at Buffalo
- Start date
- 2024-12-02
- Primary completion
- 2025-05-23
- Sex
- All
- Age range
- from 20 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06749912