Treatment for Low Back Pain with Discogen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and feasibility of the Discogen device in alleviating low back and radicular leg pain through a double-blinded, two-arm, randomized controlled pilot feasibility approach. A total of 40 subjects will be enrolled, with 20 receiving the Discogen treatment and 20 receiving a sham treatment. Participants will be followed for 60 days, during which their pain levels will be assessed using a Numerical Pain Scale and the Oswestry Disability Index. The study aims to determine the effectiveness of the treatment in reducing pain and improving disability.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Clark Smith, MD, PhD — Columbia University
• Study coordinator: Clark Smith, MD, PhD
• Email: cs3028@cumc.columbia.edu
• Phone: 212-305-2134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.