NCT07313826

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jan 2028

First Submitted

Initial submission to the registry

December 30, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

December 30, 2025

Last Update Submit

February 12, 2026

Conditions

Chronic Low Back Pain

Keywords

chronic painlow back painelectrical stimulationlaser therapy

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.

    Weeks 1-12

  • Pain Medication Use

    Opioid Use Diary

    Weeks 1-12

Secondary Outcomes (2)

  • Physical Function

    Weeks 1-12

  • Sleep Disturbance

    Weeks 1-12

Other Outcomes (2)

  • Pain Catastrophizing

    Weeks 1-12

  • Perceived Efficacy

    Weeks 1-12

Study Arms (2)

Active Neurolumen

EXPERIMENTAL

The Active Neurolumen group will utilize an active device

Device: Active Neurolumen

Inactive Neurolumen

SHAM COMPARATOR

The Inactive Neurolumen group will utilize an inactive device

Device: Inactive Neurolumen

Interventions

Inactive NeurolumenDEVICE

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

Inactive Neurolumen
Active NeurolumenDEVICE

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.

Active Neurolumen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Central Study Contacts

Director, Research Administration DVCIPM

CONTACT

301-400-4242dvcipm@usuhs.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Active Neurolumen device compared to inactive/sham
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 13, 2026

Record last verified: 2026-01

Locations

US(1)