This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.
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.
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).
Parallel
Active Neurolumen
DeviceNeurolumen 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
DeviceThe sham Neurolumen device will look the same an the Active Neurolumen, and will appear to turn on, but will not provide any treatment
Pain Intensity
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Pain Medication Use
Opioid Use Diary
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)
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.
Pain Catastrophizing
University of Washington Concerns About Pain Six Item Short Form (UW-CAP SF-6). Each item is scored on a scale of 1-5, with 1=never and 5=always. Items are summed and t-scored (0-100), with higher scores denoting more pain catastrophizing.
Perceived Efficacy
Patient Global Impression of Change Scale (PGIC). Each item is scored on a scale 1-5, with 1=very much improved and 7= Very much worse. Items will be summed and t-scored (0-100), with higher scores denoting more negative change.
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Defense and Veterans Center for Integrative Pain Management
Lead sponsor
Neurolumen LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
