Discogen for Low Back Pain
This study is testing a device called Discogen, which uses low-intensity pulsed ultrasound (LIPUS) to treat low back pain caused by a disc herniation (a slipped or bulging disc). Researchers want to see if Discogen is safe and effective in reducing back and leg pain. You might be able to join if you are between 21 and 75 years old. The study will compare Discogen treatment to a sham treatment (where the device is on but not delivering ultrasound). The main goal is to measure how much your pain changes after 30 and 60 days. This is a pilot study, meaning it's a small, early study to see if a larger study is worthwhile.
- Study design
- This is a double-blinded, randomized controlled pilot study with two groups, involving 40 participants in total. One group will receive the Discogen treatment, and the other will receive a sham treatment.
- What's involved
- Participants will be followed for 60 days, and will need to complete study forms and communicate with the investigator.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 60 days after treatment to assess safety and effectiveness.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Discogen for Low Back Pain
At a glance
Conditions
NCT06611397
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Irving Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Clark Smith, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary Effectiveness30 and 60 days.
Percent change from baseline for Numerical Pain Scale (NPS) radicular leg pain at 30 and 60 days. The NPS is a patient-reported assessment of pain intensity, ranging from 0 (No pain) to 10 (Severe pain).
- Primary Safety60 days
Collection of all adverse events, including any device or procedure-related adverse events.