Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Neurolumen, Inactive Neurolumen.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
Overview
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 Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data).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.
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
Primary outcome measures
- Pain Intensity [Time frame: Weeks 1-12]
- Pain Medication Use [Time frame: Weeks 1-12]
Secondary outcome measures (2)
- Physical Function [Time frame: Weeks 1-12]
- Sleep Disturbance [Time frame: Weeks 1-12]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Naval Medical Center Portsmouth — Portsmouth
Identifiers
NCT: NCT07313826 · USUHS.2025-167