Discogen for Low Back Pain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Disc Herniation
In brief
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.
Key facts
- Study ID
- NCT06611397
- Run by
- Columbia University
- People needed
- 5
- Starts
- 2025-03-15
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The subject may be included in the study if the following conditions are met:
- Adult (> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits
- Able and willing to complete study forms and communicate with the investigator
- Presenting with unilateral radicular leg pain with or without axial back pain of >1 month duration
- No epidural injections at treatment site within the last three months
- Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
- Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
- 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%).
You may not qualify if…
- Pregnant or breastfeeding patient
- Younger than 21 or older than 75 years
- Presenting with motor deficits
- Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse)
- Presence of metal hardware within the lumbosacral spine
- History of spine surgery at the level of treatment.
- 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)
- Severe lumbar central canal stenosis (greater than 50%)
- Severe lumbar foraminal stenosis (greater than 50%)
- Severe herniated lumbar disc 4(Grade 2 and above)
- Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis
- Unable to understand and complete research questionnaires
- Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes.
- BMI greater than 30
- Implanted spinal stimulators
- Epidural injections at treatment site within the last three months
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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