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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Active Neurolumen; Device: Inactive Neurolumen

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 Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data).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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director, Research Administration DVCIPM; Phone Number: 301-400-4242; Email: dvcipm@usuhs.edu

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth
      • Principal Investigator: Jeffrey Moore, MD
      • Contact: Mary Director, Research Compliance, DVCIPM, MS, RN; Phone Number: 3015388785; Email: mary.mcduffie.ctr@usuhs.edu
      • Contact: Timothy Hope Clinical Research Coordinator, BS; Phone Number: 2403938696 61905326400; Email: timothy.hope.ctr@usuhs.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Neurolumen; The Active Neurolumen group will utilize an active device	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.
Sham Comparator: Inactive Neurolumen; The Inactive Neurolumen group will utilize an inactive device	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Medication Use	Opioid Use Diary	Weeks 1-12
Pain Intensity	Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.	Weeks 1-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale. Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do. Items will be summed and t-scored (0-100)	Weeks 1-12
Sleep Disturbance	Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale. Each item is scored on a scale 1-5, with 1=not at all and 5=very much. Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance.	Weeks 1-12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	University of Washington Concerns About Pain Six Item Short Form (UW-CAP SF-6). Each item is scored on a scale of 1-5, with 1=never and 5=always. Items are summed and t-scored (0-100), with higher scores denoting more pain catastrophizing.	Weeks 1-12
Perceived Efficacy	Patient Global Impression of Change Scale (PGIC). Each item is scored on a scale 1-5, with 1=very much improved and 7= Very much worse. Items will be summed and t-scored (0-100), with higher scores denoting more negative change.	Weeks 1-12

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Collaborators: Neurolumen LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; low back pain; electrical stimulation; laser therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Low Back Pain
• Other Study ID Numbers: USUHS.2025-167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No