Discogen for Low Back Pain

Last updated: April 6, 2026
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Discogen Low pulsed ultrasound treatment

Discogen Sham Treatment

Clinical Study ID

NCT06611397
AAAU8219
  • Ages 21-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

The subject may be included in the study if the following conditions are met:

  1. Adult (> 21 y.o.) males and females legally able and willing to participate andprovide consent in the study and attend follow-up visits

  2. Able and willing to complete study forms and communicate with the investigator

  3. Presenting with unilateral radicular leg pain with or without axial back pain of >1month duration

  4. No epidural injections at treatment site within the last three months

  5. Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)

  6. Clinical presentation of sensory radiculopathy referable to single-level discdisease/herniation at L3-4, L4-5 or L5-S1

  7. MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, butpositive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderateforaminal or spinal stenosis (less than 50%).

Exclusion

Exclusion Criteria:

  1. Pregnant or breastfeeding patient

  2. Younger than 21 or older than 75 years

  3. Presenting with motor deficits

  4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability orworse)

  5. Presence of metal hardware within the lumbosacral spine

  6. History of spine surgery at the level of treatment.

  7. Lumbar spine pathology that may increase procedural risk and/or influence symptomsand/or generate unrelated adverse events (per the discretion of the study PI)

  8. Severe lumbar central canal stenosis (greater than 50%)

  9. Severe lumbar foraminal stenosis (greater than 50%)

  10. Severe herniated lumbar disc 4(Grade 2 and above)

  11. Lumbar instability on flexion/extension plain films, greater the Grade 1spondylolisthesis

  12. Unable to understand and complete research questionnaires

  13. Any severe medical condition preventing the patient from safely and effectivelybeing treated in the study or reporting study outcomes.

  14. BMI greater than 30

  15. Implanted spinal stimulators

  16. Epidural injections at treatment site within the last three months

Study Design

Total Participants: 5
Treatment Group(s): 2
Primary Treatment: Discogen Low pulsed ultrasound treatment
Phase:
Study Start date:
March 15, 2025
Estimated Completion Date:
August 31, 2027

Study 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

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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