Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life

Not Applicable

Recruiting

Brief Summary: 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.

Detailed Description: Participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. Participants will be screened for inclusion and exclusion criteria and consented. This study utilizes a counterbalanced cross-over design. Each participant will complete both conditions: 1) Intervention (wrap), or 2) Control (Nothing). A counterbalanced assignment approach will be used to determine the starting condition for each participant (Phase 1). After completion of Phase 1, each participant will complete the remaining condition for Phase 2.

Each phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in Phase 1, 2 weeks in Phase 2). When participants are in the Intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). To support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. The Researchers will administer simple daily surveys to log compliance to treatment.

A pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Pain	From enrollment to the end of treatment at 4 weeks	Patients will report their level of pain daily and reflect on their pain over the past over the past 1-week at the start of the study and past 2-weeks during the follow-up surveys Pain Scale: 1-10, higher score = more pain.
Function survey	From enrollment to the end of treatment at 4 weeks	Function will be assessed daily and every 2-weeks by survey.
Function test	From enrollment to the end of treatment at 4 weeks	Function will be assessed every 2-weeks by a function screening via 5-repitition sit-to-stand. Function Scale: 5 point scale from "not at all" to "very much" indicating how much pain interfered with day-to-day activities.

Secondary Outcome Measures

Name	Time	Method
Medication usage	From enrollment to the end of treatment at 4 weeks	Daily screening and every 2-weeks the participants will be asked about what prescription and over-the-counter medications, along with cannabis and THC, were used to help mediate the pain.
Other pain and rehabilitation use	From enrollment to the end of treatment at 4 weeks	Participants will be surveyed daily and every 2-weeks about any other type of rehabilitation they used to help mediate their pain.
Device use- Frequency	For the 2-week device use period.	Frequency of use will be recorded daily during the 2-week device intervention period Frequency scale: 0-5+ on a 6 point scale indicating how often the device was used per day.
Device use- Duration	For the 2-week device use period.	Duration of use will be recorded daily during the 2-week device intervention period Scale: 2 point- default (20-minutes) or more. Free response in branching logic to insert amount of time if more than default.
Device use- Type	For the 2-week device use period.	Type of use will be recorded daily during the 2-week device intervention period. Scale 1- How worn, gives options for under/over clothes \& activity, resting, sitting, standing, ADLs, free response.