RECRUITING

Discogen for Low Back Pain

Talk to us

Conditions

Disc Herniation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-15
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06611397

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.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Pregnant or breastfeeding patient
  2. 2. Younger than 21 or older than 75 years
  3. 3. Presenting with motor deficits
  4. 4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse)
  5. 5. Presence of metal hardware within the lumbosacral spine
  6. 6. History of spine surgery at the level of treatment.
  7. 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. 8. Severe lumbar central canal stenosis (greater than 50%)
  9. 9. Severe lumbar foraminal stenosis (greater than 50%)
  10. 10. Severe herniated lumbar disc 4(Grade 2 and above)
  11. 11. Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
  12. 12. Unable to understand and complete research questionnaires
  13. 13. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
  14. 14. BMI greater than 30
  15. 15. Implanted spinal stimulators
  16. 16. Epidural injections at treatment site within the last three months

Contacts and Locations

Study Contact

Clark Smith, MD. PhD
CONTACT
212-305-2134
cs3028@cumc.columbia.edu
Michael Spinner, MS
CONTACT
212-305-9416
ms6431@cumc.columbia.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-15
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2025-03-15
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Disc Herniation

Additional Relevant MeSH Terms

  • Disc Herniation