NCT07313826

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

Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Defense and Veterans Center for Integrative Pain Management · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.

Detailed description

Chronic low back pain is debilitating and difficult to treat. The commercially-available Neurolumen medical device uses a combination of electrical stimulation, low-level laser, and LED therapies to treat pain. Separately, each of these treatments has shown promise for treating chronic pain. In a recent survey by the manufacturer involving over 4700 Veterans who were prescribed a Neurolumen device through their local VA facility, 93% of patients reported a reduction in pain levels, and 52% report reduction in medication, including 6% who reported cessation of all medication. Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data).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 preliminary evidence for the utility of Neurolumen for treating chronic pain; yet, it is unknown whether these findings generalize to other populations. Furthermore, while a reduction in retrospective pain and medication use are promising, prospectively-collected clinical outcomes of Neurolumen use have yet to be examined. This study will examine the feasibility and efficacy of the Neurolumen devices for treating chronic lower back pain using a double-blind pilot randomized controlled trial design with a placebo/waitlist control.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	Active Neurolumen	Neurolumen has been cleared by the FDA for the treatment of pain (FDA: 142025) and utilizes a combination of low-level lasers, Light-Emitting Diodes, and electrical stimulation over a 30-minute treatment period to target inflammation and circulation to the affected area. Participants will use the device daily for 4 weeks.
DEVICE	Inactive Neurolumen	The sham Neurolumen device will look the same an the Active Neurolumen, and will appear to turn on, but will not provide any treatment

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-01-02
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study