Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy
Not yet recruitingNot applicableNCT07313826
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.
Study details
- Official title
- Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
- Conditions
- Interventions
- Device: Active Neurolumen
- Device: Inactive Neurolumen
- Sponsor
- Defense and Veterans Center for Integrative Pain Management
- Collaborators
- Neurolumen LLC
- Start date
- 2026-05-01
- Primary completion
- 2028-01-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07313826