| NCT ID | NCT06611397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Disc Herniation |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2026-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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 year