Discogen for Low Back Pain

Launched by COLUMBIA UNIVERSITY · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Discogen for Low Back Pain," is investigating a new treatment for patients experiencing pain from a herniated disc in their lower back. The study will involve 40 participants, who will be divided into two groups. One group will receive the actual Discogen treatment, while the other group will receive a sham treatment, which means they won't actually receive the active therapy but will undergo a similar procedure for comparison. Both groups may also use pain relief medications if needed. The trial is currently looking for volunteers aged 21 to 75 who have had leg pain for more than a month due to a specific type of disc problem, as seen on MRI scans.

To be eligible for this study, participants should be able to provide consent and complete study forms, have unilateral leg pain with a certain level of severity, and have not had recent epidural injections. Those with severe spinal issues, previous spine surgeries, or certain medical conditions may not be eligible. If you participate, you can expect to attend follow-up visits to monitor your progress. This trial is an important step in understanding how effective the Discogen treatment may be for managing low back pain.

Gender

ALL

Eligibility criteria

• • 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 and provide 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 \>1 month 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 disc disease/herniation at L3-4, L4-5 or L5-S1
• • 7. MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%).
• 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 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