Skip to main content
OpenTrials
Completed

NCT Number: NCT06749912

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Back Pain Acute Low Back Pain Back Pain Low Back Pain Lower Back Pain Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low back pain wrap

Device

The low back pain wrap device includes heat, vibration, and red light to assist with reducing pain sensation, improving function.

Primary outcomes

  1. Pain

    Time frame: 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.

  2. Function survey

    Time frame: From enrollment to the end of treatment at 4 weeks

    Function will be assessed daily and every 2-weeks by survey.

  3. Function test

    Time frame: 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 outcomes

  1. Medication usage

    Time frame: 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.

  2. Other pain and rehabilitation use

    Time frame: 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.

  3. Device use- Frequency

    Time frame: 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.

  4. Device use- Duration

    Time frame: 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.

  5. Device use- Type

    Time frame: 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.

Other outcomes

  1. Device use satisfaction

    Time frame: At the end of the 2-week device use period.

    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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.