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โ† Trials
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Discogen for Low Back Pain

RecruitingNAAges 21 Years - 75 YearsAllColumbia University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Discogen Low pulsed ultrasound treatment
  • Discogen Sham Treatment
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Where

1 site
Columbia University Irving Medical Center
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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