Neurolumen for Chronic Lower Back Pain

This study is looking at how well the Neurolumen device helps people with chronic lower back pain. Neurolumen uses a combination of electrical stimulation, low-level lasers, and Light-Emitting Diodes (LEDs) to help reduce pain and improve blood flow. We want to see if this device can reduce your pain intensity and how much pain medication you need. You might be able to join if you are between 18 and 70 years old, have had lower back pain for over 3 months with an average pain score of 4 or higher, and can comfortably sit or lie down for 30 minutes during treatments. The study is currently recruiting about 50 participants.

Study design
This is a double-blind, pilot randomized controlled trial, meaning neither you nor the study staff will know if you are receiving the active Neurolumen device or an inactive (sham) device. Approximately 50 people will participate.
What's involved
You will need to sit or lie down for 30 minutes during treatments. The study will measure your pain intensity and pain medication use for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your pain intensity and pain medication use will be measured for 12 weeks after starting treatment.

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

NCT07313826

Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy

Not Yet Recruiting
NAAges 18–70InterventionalTreatment
Defense and Veterans Center for Integrative Pain Management
~50 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Active NeurolumenInactive Neurolumen

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Intensity
Measured over Weeks 1-12
+1 more outcome measured
Chronic Low Back Pain
1 sites across 1 states
Virginia1
Director, Research Administration DVCIPM
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Eligibility criteria

Inclusion

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

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).
  • Pain IntensityWeeks 1-12

    Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.

  • Pain Medication UseWeeks 1-12

    Opioid Use Diary