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At-Home Device for Chronic Lower Back Pain

This study is looking at how well an at-home device works for people with chronic lower back pain (pain lasting more than 3 months). The device combines electrical stimulation using a TENS 7000 device, sound stimulation with AKG 845 BT headphones, and integrative health techniques like guided deep breathing, health coaching, and journaling. The main goal is to see how often people use the device as instructed over 12 weeks. You might be able to join if you are 18 or older, live near the University of Minnesota, can understand English, and have chronic lower back pain with a pain score of 4 or higher on the PEG (Pain, Enjoyment of Life, General Activity) scale. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is designed to assess the usability and satisfaction of a take-home device.
What's involved
You will be shown how to use the TENS device and headphones, trained on the stimulation procedure, and instructed on integrative health modalities. You will also receive a tablet with videos, a reflective journal, and be set up for health coaching visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for compliance rate is measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06619418

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

Recruiting
NAAges 18+InterventionalDevice feasibility
University of Minnesota
~20 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:TENS deviceIntegrative health modalities

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
compliance rate
Measured over 12 weeks

Conditions

Chronic Lower Back Pain

Explore related trials

Lower Back Pain

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Molly Sturges · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Grace Conchas
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • compliance rate12 weeks

    Measure compliance in terms of time using the integrative health devices and the multi-modal stimulation device over a period of 12 weeks to determine the effect on participant compliance by adding electrical stimulation to the device.