Discogen for Low Back Pain
Start Date
3/15/2025
Completion Date
8/1/2027
Summary
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.
Detailed Description
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain. This study will enroll 40 evaluable subjects and follow them for 60 days. 1. Investigate the safety and feasibility of the Discogen device to alleviate back/radicular leg pain 2. Assess the mean reduction in back and radicular leg pain following Discogen treatment. * Primary Safety - collection of all adverse events, including any device- or procedure-related adverse events * Primary Effectiveness -percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The scale ranges from 0(No pain) to 10 (Severe pain). * Secondary Effectiveness: * Change from baseline in Oswestry Disability Index at 30 and 60 days. The Index ranges from 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), to 81-100% (bed bound). * Percent change from baseline NPS back pain at 30 and 60 days
Eligibility Criteria
Age Range: 21 years to 75 years
Interventions
Discogen Low pulsed ultrasound treatment
Discogen Sham Treatment
Conditions
Locations
Columbia University Irving Medical Center
New York, New York 10032
United States