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

NCT07313826 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-13

No results posted yet for this study

Summary

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

Conditions

  • Chronic Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Neurolumen LLC

    collaborator UNKNOWN

  • Defense and Veterans Center for Integrative Pain Management

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-01-01
Completion
2028-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07313826 on ClinicalTrials.gov