Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study
Defense and Veterans Center for Integrative Pain Management
Summary
This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.
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, aver…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 ad…
Interventions
- DeviceActive 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.
- DeviceInactive 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
Location
- Naval Medical Center PortsmouthPortsmouth, Virginia