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

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 Overview

• Status: Completed
• Conditions: Lower Back Pain; Acute Low Back Pain; Lower Back Pain Chronic
• Intervention / Treatment: Device: Low back pain wrap

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower back pain wrap; During this arm the participants will wear the low back pain wrap device	Device: Low back pain wrap; The low back pain wrap device includes heat, vibration, and red light to assist with reducing pain sensation, improving function.
No Intervention: No device; No device will be used, but symptoms and function will be reported

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	From enrollment to the end of treatment at 4 weeks
Function survey	Function will be assessed daily and every 2-weeks by survey.	From enrollment to the end of treatment at 4 weeks
Function test	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.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication usage	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.	From enrollment to the end of treatment at 4 weeks
Other pain and rehabilitation use	Participants will be surveyed daily and every 2-weeks about any other type of rehabilitation they used to help mediate their pain.	From enrollment to the end of treatment at 4 weeks
Device use- Frequency	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.	For the 2-week device use period.
Device use- Duration	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.	For the 2-week device use period.
Device use- Type	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.	For the 2-week device use period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device use satisfaction	At the conclusion of the 2-week device use period the participants will fill out a device satisfaction survey examining their experience with the device. 25 question survey on how they felt the device worked. Most questions are on a 5-point Likert scale from "strongly agree" to "strongly disagree". The directionality changes based upon the question. Example: I could more easily complete daily tasks without pain during the study period when I used the device.; Strongly Agree; Agree; Neither Agree nor Disagree; Disagree; Strongly Disagree	At the end of the 2-week device use period.

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Kyle J Kelleran, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; acute low back pain; symptom reduction; pain sensation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: STUDY00008828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes