Actively Recruiting
Discogen for Low Back Pain
Led by Columbia University · Updated on 2026-04-09
5
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
D
Discogen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Discogen for Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males and females over 21 years old willing to participate and provide consent
- Able and willing to complete study forms and communicate with the investigator
- Having unilateral radicular leg pain with or without back pain lasting more than one month
- No epidural injections at the treatment site in the past three months
- Leg pain score between 4 and 9 on a 0 to 10 pain scale
- Clinical signs of sensory radiculopathy related to single-level disc disease at L3-4, L4-5, or L5-S1
- MRI shows disc disease or herniation at L3-4, L4-5, or L5-S1 with mild to moderate spinal or foraminal stenosis less than 50%
You will not qualify if you...
- Pregnant or breastfeeding
- Younger than 21 or older than 75 years
- Presence of motor deficits
- Baseline Oswestry Disability Index of 41% or higher (severe disability or worse)
- Metal hardware in the lower spine
- History of spine surgery at the treatment level
- Lumbar spine conditions that increase procedural risk or symptoms unrelated to the study
- Severe lumbar central canal stenosis over 50%
- Severe lumbar foraminal stenosis over 50%
- Severe lumbar disc herniation grade 2 or above
- Lumbar instability or spondylolisthesis greater than grade 1
- Unable to understand or complete study questionnaires
- Serious medical conditions preventing safe treatment or reporting
- Body mass index over 30
- Implanted spinal stimulators
- Epidural injections at the treatment site within the last three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Clark Smith, MD, PhD
CONTACT
M
Michael Spinner, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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