Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain

University of Minnesota (UMN)

Status

Enrolling

Conditions

Chronic Lower Back Pain

Treatments

Behavioral: Integrative health modalities

Device: TENS device

Study type

Interventional

Funder types

Other

Identifiers

NCT06619418

ENT-2024-33112

Details and patient eligibility

About

Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.

This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be 18 years of age or older
Must be within commuting distance to the University of Minnesota
Able to provide consent and follow study instructions
Must be able to understand English
Must have chronic LBP, which is defined as lower back pain for more than 3 months
A score of 4 or higher on the PEG
Must be willing to commit to full duration of the study
Not currently taking any benzodiazepines or sedative hypnotics

Exclusion criteria

Back Pain associated with:
Spondylolisthesis or spinal stenosis
Sciatica or radiculopathy
Rhematologic or inflammatory disease
Trauma, fracture, dislocation, or previous back surgery
A score of 10 on the PEG
Pregnant
Have an electrically implanted device, such as a pacemaker.
Heart Disease
Epilepsy
Cancer
Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.
Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.