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

Part of paid clinical trials in Portsmouth, Virginia.

Sponsor
Defense and Veterans Center for Integrative Pain Management
Study ID
NCT07313826
Status
Not Yet Recruiting

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Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Neurolumen — 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 — 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

Study Details

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

Key Dates

Start date
May 1, 2026
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Neurolumen
    The Active Neurolumen group will utilize an active device
  • Sham Comparator: Inactive Neurolumen
    The Inactive Neurolumen group will utilize an inactive device

Primary Outcome Measure

Pain Intensity [ Time Frame: Weeks 1-12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center PortsmouthPortsmouthVirginia23708
Timothy Hope Clinical Research Coordinator, BS
[email protected]
61905326400
Mary Director, Research Compliance, DVCIPM, MS, RN
[email protected]
3015388785
Jeffrey Moore, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Naval Medical Center Portsmouth· Portsmouth, VA

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