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

NCT ID: NCT06749912

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-05-23

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lower back pain wrap

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

Group Type: EXPERIMENTAL

Low back pain wrap

Intervention Type: DEVICE

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

No device

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low back pain wrap

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Kyle Kelleran

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle J Kelleran, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

University at Buffalo

Buffalo, New York, United States

Countries

United States

Other Identifiers

STUDY00008828

Identifier Type: -

Identifier Source: org_study_id