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

University at Buffalo (UB)

Status

Completed

Conditions

Lower Back Pain

Acute Low Back Pain

Lower Back Pain Chronic

Treatments

Device: Low back pain wrap

Study type

Interventional

Funder types

Other

Identifiers

NCT06749912

STUDY00008828

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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