Neurolumen for Low Back Pain

Overseen By Director, Research Administration DVCIPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Defense and Veterans Center for Integrative Pain Management

Disqualifiers: Age <18 or >70, Pacemakers, Recent back surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Neurolumen to determine its effectiveness in reducing chronic low back pain. Participants will use either an active Neurolumen device or a similar inactive device to compare effects. Individuals with back pain lasting more than three months and experiencing moderate pain may qualify. Participants must be able to sit or lie down for 30-minute sessions. As an unphased trial, this study provides a unique opportunity to explore a new approach to managing chronic pain.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Neurolumen device is safe for treating low back pain?

Research has shown that the Neurolumen device has been studied for its effects on chronic low back pain. However, these studies provide limited detailed information about its safety. Without this safety data, determining how well people tolerate the Neurolumen remains challenging.

The trial is labeled as "Not Applicable" for phases, which might indicate that Neurolumen is already approved for another use, suggesting some level of safety in humans. Generally, approved treatments have undergone safety testing, but without specific data, this remains an assumption.

Prospective participants should consider discussing the trial with study coordinators or their doctor. They can provide more detailed information and help clarify the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurolumen is unique because it combines light therapy, electrical stimulation, and heat application in one device to target low back pain. Unlike traditional treatments such as pain medications or physical therapy, Neurolumen aims to relieve pain by enhancing circulation and reducing inflammation directly at the source. Researchers are excited about its potential to offer a non-invasive, drug-free alternative that addresses pain more holistically and potentially with fewer side effects.

What evidence suggests that the Neurolumen device is effective for low back pain?

Research has shown that the Neurolumen device might help reduce chronic low back pain. In one study, participants reported their average pain levels dropping from 7.01 out of 10 to 3.38 after six weeks. This suggests the device can significantly reduce pain for those with chronic low back pain. In this trial, participants will join either the Active Neurolumen group, using an active device, or the Inactive Neurolumen group, using an inactive device. The Neurolumen device uses electrical stimulation, LEDs, and lasers to relieve pain. These findings provide early support for its potential effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women who have had lower back pain with an average pain score of 4 or higher for more than 3 months. They must be able to sit or lay down for 30 minutes and use the Neurolumen device correctly. Participants should agree to use effective contraception during the study.

Inclusion Criteria

I can sit or lay down for 30 minutes without discomfort.

Demonstrated ability to correctly use the device and maintain adequate sensor contact throughout (assisted or unassisted)

I have had lower back pain with a pain score of 4 or higher for more than 3 months.

Exclusion Criteria

I am not willing to use effective birth control if there's a chance I could get pregnant.

I am between 18 and 70 years old.

Persons with Pacemakers, or interstitial pumps, or spinal cord stimulator in ON mode

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Neurolumen device treatment for chronic lower back pain

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurolumen

Trial Overview

The study tests the Neurolumen medical device's effectiveness on chronic low back pain. It involves comparing an active Neurolumen device, which provides electrical stimulation, LED, and laser therapy, against an inactive version (placebo) of the same device.

How Is the Trial Designed?

Group I: Active Neurolumen Experimental Treatment 1 Intervention

The Active Neurolumen group will utilize an active device

Group II: Inactive Neurolumen Placebo Group 1 Intervention

The Inactive Neurolumen group will utilize an inactive device

Who Is Running the Clinical Trial?

Defense and Veterans Center for Integrative Pain Management

Lead Sponsor

Trials

20

Recruited

2,200+

Neurolumen LLC

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07313826?term=NA

Treatment of Chronic Lower Back Pain With a Combination ...

This study will examine the feasibility and efficacy of the Neurolumen devices for treating chronic lower back pain using a double-blind pilot ...

2.

ctv.veeva.com

ctv.veeva.com/study/treatment-of-chronic-lower-back-pain-with-a-combination-of-electrical-stimulation-led-and-laser-th

Treatment of Chronic Lower Back Pain With a Combination of ...

Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data). Thus, there is theoretical support and ...

3.

withpower.com

withpower.com/trial/phase-chronic-pain-4-2026-2341f

Neurolumen for Low Back Pain · Info for Participants

This trial is for women who have had lower back pain with an average pain score of 4 or higher for more than 3 months. They must be able to sit ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11075829/

Efficacy of neuromobilization in the treatment of low back pain

However, some studies have shown that NM can significantly reduce the symptoms of LBP, while others have failed to find similar positive effects ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ...

Specifically, patients treated with SCS therapies were more likely to achieve at least 50% pain reduction in either back or leg when measured at ...

6.

neurolumen.com

neurolumen.com/product2/

Product Info old – Neurolumen

This unit has a total of 1 Treatment Pad. This is used for patients with a single area of pain or will spend the time to treat multiple areas.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17163911/

Safety and efficacy of percutaneous neuromodulation ...

For many patients with subacute radiating low back pain, PNT significantly reduced pain and self-rated disability, and improved sleep quality and activity ...