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

NCT06749912 | Completed FDA Device

• 1 other identifier: STUDY00008828
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain; Lower Back Pain Chronic; Acute Low Back Pain

Keywords

Low back pain; acute low back pain; symptom reduction; pain sensation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Medication usage

  From enrollment to the end of treatment at 4 weeks

• Other pain and rehabilitation use

  From enrollment to the end of treatment at 4 weeks

• Device use- Frequency

  For the 2-week device use period.

• Device use- Duration

  For the 2-week device use period.

• Device use- Type

  For the 2-week device use period.

Other Outcomes (1)

• Device use satisfaction

  At the end of the 2-week device use period.

Study Arms (2)

Lower back pain wrap

EXPERIMENTAL

During this arm the participants will wear the low back pain wrap device

Device: Low back pain wrap

No device

NO INTERVENTION

No device will be used, but symptoms and function will be reported

Interventions

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.

Lower back pain wrap

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyle J Kelleran, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 27, 2024
• Study Start: December 2, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)