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.

NCT06611397

Discogen for Low Back Pain

Recruiting
NAAges 21–75InterventionalTreatment
Columbia University
~5 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Discogen Low pulsed ultrasound treatmentDiscogen Sham Treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness
Measured over 30 and 60 days.
+1 more outcome measured
Disc Herniation

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.

  • Clark Smith, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

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  • 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.