Treatment for Low Back Pain with Discogen
Double-Blinded Pilot Feasibility Study of the Discogen Device to Alleviate Discogenic Back/Radicular Leg Pain
This study is testing whether the Discogen device can help people with low back and leg pain feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06611397 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 75 with unilateral radicular leg pain lasting over one month and specific MRI findings indicating disc disease.
Not a fit: Patients who are pregnant, breastfeeding, or have severe conditions such as extruded disc herniation or tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from low back and leg pain for patients suffering from disc herniation.
How similar studies have performed: While this approach is novel, similar studies have shown promise in using ultrasound treatments for pain management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.