Key Points
- A new clinical study is now underway for patients with back and leg pain caused by spinal disc degeneration.
- Researchers are applying low-intensity, pulsed focused ultrasound to promote tissue repair and relieve inflammation.
Researchers at Columbia University Irving Medical Center have treated the first patients in a new clinical trial (NCT06611397) assessing the safety and feasibility of using focused ultrasound to alleviate back and leg pain. This study is the first to test Discogen’s DiscRx™ system, which uses low-intensity, pulsed focused ultrasound to promote the repair of early-stage spinal disc disease and relieve inflammation. Its mechanism of action is promoting tissue remodeling repair to slow the progression of spinal disc disease.
The double-blinded, two-arm, prospective, randomized trial will enroll 40 participants with discogenic back pain and/or radicular leg pain, or pain caused by irritation or compression of a spinal nerve root. Participants will be randomly assigned to one of two cohorts. The first cohort will receive three daily unilateral DiscRx treatments within a one-week period, and subjects in the second cohort will receive a similar sham protocol.
Researchers will follow participants for 60 days to assess any reported changes in pain or adverse events.
The Foundation is funding this clinical trial, which is being led by Clark Smith, MD, MPH, an associate professor of rehabilitation and regenerative medicine at Columbia University’s Vagelos College of Physicians and Surgeons.
“Debilitating leg pain from a herniated disc significantly reduces quality of life,” said Dr. Smith. “A noninvasive alternative to traditional treatments like medication, injections, or surgery could offer a safer, more accessible option for patients.”
For Patients
If you are interested in participating in this study at Columbia University Irving Medical Center in New York, or learning more, please contact
Clark Smith, MD, PhD
cs3028@cumc.columbia.edu
Michael Spinner
212-305-9416
ms6431@cumc.columbia.edu