Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a home device blend electricity, sound, and mindfulness to ease back pain?

NCT ID NCT06619418

Symptom relief Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests a take-home device that combines electrical stimulation (TENS), sound, and mindfulness techniques for people with chronic lower back pain. The goal is to see how usable and satisfying the device is over 12 weeks. Participants will be trained and then use the device at home, along with guided breathing and journaling. The study focuses on whether people will stick with the treatment and find it acceptable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A take-home device combining TENS (electrical stimulation), acoustic stimulation via headphones, and integrative health techniques like guided breathing and journaling.
What this could lead to
If successful, this could lead to a convenient, at-home, drug-free option for managing chronic lower back pain, potentially improving quality of life.
What could go wrong
This is a small pilot study focused on usability, not effectiveness. The device may not reduce pain, and individual results may vary. Some people may find the stimulation uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lower back pain are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lower back pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.