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

NCT ID: NCT07313826

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2028-01-01

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 Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data).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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Neurolumen

The Active Neurolumen group will utilize an active device

Group Type: EXPERIMENTAL

Active Neurolumen

Intervention Type: DEVICE

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.

Inactive Neurolumen

The Inactive Neurolumen group will utilize an inactive device

Group Type: SHAM_COMPARATOR

Inactive Neurolumen

Intervention Type: DEVICE

The sham Neurolumen device will look the same an the Active Neurolumen, and will appear to turn on, but will not provide any treatment

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurolumen LLC

UNKNOWN

Sponsor Role: collaborator

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Central Contacts

Director, Research Administration DVCIPM

Role: CONTACT

dvcipm@usuhs.edu

301-400-4242

Facility Contacts

Alexandra Clinical Research Nurse Manager, MSN RN

Role: primary

alexandra.kane.ctr@usuhs.edu

61905326400

Mary Director, Research Compliance, DVCIPM, MS, RN

Role: backup

mary.mcduffie.ctr@usuhs.edu

3015388785

Other Identifiers

USUHS.2025-167

Identifier Type: -

Identifier Source: org_study_id