Chronic Low Back PainNCT07313826
Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy
A study testing Active Neurolumen and Inactive Neurolumen in people with Chronic Low Back Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
This study will evaluate the impact of the Neurolumen medical device on chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Active Neurolumen and Inactive Neurolumen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Timothy Hope Clinical Research Coordinator, BS, 61905326400 ext. 2403938696, timothy.hope.ctr@usuhs.edu
Mary Director, Research Compliance, DVCIPM, MS, RN, 3015388785, mary.mcduffie.ctr@usuhs.edu
About this study
Official title: Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.
Read the 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
- Being tested
- Active Neurolumen, Inactive Neurolumen
- Keywords
- chronic pain, low back pain, electrical stimulation, laser therapy
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Active Neurolumen | Experimental | The Active Neurolumen group will utilize an active device Receives: Device: Active Neurolumen |
| Inactive Neurolumen | Sham comparator | The Inactive Neurolumen group will utilize an inactive device Receives: Device: Inactive Neurolumen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Measured: Weeks 1-12
Pain Medication Use
Opioid Use Diary
Measured: Weeks 1-12
Secondary outcomes (2)
Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale.
Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do. Items will be summed and t-scored (0-100)
Measured: Weeks 1-12
Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale. Each item is scored on a scale 1-5, with 1=not at all and 5=very much. Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active Neurolumen device compared to inactive/sham
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Collaborators
- Neurolumen LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313826
- Sponsor's protocol ID
- USUHS.2025-167
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
- ClinicalTrials.gov ID
- NCT07313826
- Acronym / sponsor ID
- USUHS.2025-167
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic pain, low back pain, electrical stimulation, laser therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Collaborators
- Neurolumen LLC
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active Neurolumen device compared to inactive/sham
| Arm | Type | Receives |
|---|---|---|
| Active Neurolumen | Experimental | Device: Active NeurolumenThe Active Neurolumen group will utilize an active device |
| Inactive Neurolumen | Sham comparator | Device: Inactive NeurolumenThe Inactive Neurolumen group will utilize an inactive device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active NeurolumenNeurolumen 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 | Active Neurolumen |
| Inactive NeurolumenThe sham Neurolumen device will look the same an the Active Neurolumen, and will appear to turn on, but will not provide any treatment | Device | Inactive Neurolumen |
Primary outcome
Pain Intensity
Time frame: Weeks 1-12
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Pain Medication Use
Time frame: Weeks 1-12
Opioid Use Diary
2 secondary outcomes
Physical Function
Time frame: Weeks 1-12
Sleep Disturbance
Time frame: Weeks 1-12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Neurolumen and Inactive Neurolumen in people with Chronic Low Back Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Research Administration DVCIPM (301-400-4242, dvcipm@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Weeks 1-12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.