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New device uses light and zaps to fight back pain

NCT ID NCT07313826

Symptom relief Sponsor: Defense and Veterans Center for Integrative Pain Management Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will test whether the Neurolumen device—which combines low-level lasers, LEDs, and electrical stimulation—can reduce pain and painkiller use in 50 adults with chronic low back pain. Participants will use the device daily for 4 weeks, and some will receive a sham (inactive) version for comparison. The goal is to see if this FDA-cleared device offers a non-drug way to manage persistent back pain.

What this could mean

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

Active substance
Neurolumen device (low-level lasers, LEDs, and electrical stimulation)
What this could lead to
If it works, this could offer a drug-free option to manage chronic low back pain and reduce reliance on painkillers.
What could go wrong
This is a small pilot study (50 people) with no blinding results yet. The sham device may also provide some relief, making it hard to prove real benefit. Long-term effects are unknown.

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 50 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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 to 70 years

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: * Diagnosed with LBP with an average pain score of 4 or higher on DVPRS for \> 3 months * Ability to sit or lay down for 30 minutes during treatments * Demonstrated ability to correctly use the device and maintain adequate sensor contact throughout (assisted or unassisted) * Female participants who could possibly become pregnant must agree to use a highly effective contraceptive method from the screening period through the 4 weeks of study intervention and any use during the wait-list control period. These methods include a physical barrier method (e.g., condom) plus an additional hormonal, IUD, tubal ligation, or second type of barrier (e.g., diaphragm). In addition, they must abstain from egg collection or donation during the same period. Exclusion Criteria: * Individuals \< 18 or \>70 years of age at enrollment * Persons with Pacemakers, or interstitial pumps, or spinal cord stimulator in ON mode. * Persons who have received back surgery (open) within the last 3 months * Pregnant or sexually active female subjects who could possibly become pregnant and who are not willing to use an acceptable form of contraception (barrier method plus one of the following: second barrier, hormonal, IUD, or tubal ligation).

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Conditions

The condition(s) this trial relates to.

Chronic Pain Low Back Pain

As listed by the trial registrant

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

Chronic low 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 and phone numbers. 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

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia, 23708, United States

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