A Double-Blinded Study to Test the Safety and Effectiveness of the Discogen Device for Treating Unilateral Back and Leg Pain Caused by Disc Herniation in Adults

What this Trial Is About

Researchers are conducting a double-blinded, randomized controlled pilot feasibility study to evaluate the Discogen device for treating discogenic back and radicular leg pain. The study involves 40 adults with unilateral radicular leg pain related to disc disease or herniation at specific lumbar levels. The goal is to investigate the safety and feasibility of the Discogen device and measure its effect on pain reduction over 60 days. Participants will be randomly assigned to one of two groups. The treatment group will receive three daily unilateral Discogen low pulsed ultrasound treatments within one week, each lasting 25 minutes. The control group will receive three sham treatments over the same schedule without active ultrasound. Both groups may continue to use medications like NSAIDs or muscle relaxants for pain as needed. During the study, participants will be monitored for adverse events and changes in pain levels using the Numerical Pain Scale at 30 and 60 days. Additional assessments include changes in disability measured by the Oswestry Disability Index. Participants will complete study forms and attend follow-up visits, with safety and effectiveness outcomes collected over the 60-day period.

Discogen for Low Back Pain