Discogen for Low Back Pain

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.

Conditions

Disc Herniation

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Study Overview

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Study Details

Study overview

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.

Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain

Discogen for Low Back Pain

Condition
Disc Herniation
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or worse)
  • 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 symptoms and/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 1 spondylolisthesis
  • 12. Unable to understand and complete research questionnaires
  • 13. Any severe medical condition preventing the patient from safely and effectively being 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

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Study Record Dates

2027-03-01