Discogen for Low Back Pain (NCT06611397) | Clinical Trial Compass
RecruitingNot Applicable
Discogen for Low Back Pain
United States5 participantsStarted 2025-03-15
Plain-language 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.
Who can participate
Age range21 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Adult (\> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits
ā. Able and willing to complete study forms and communicate with the investigator
ā. Presenting with unilateral radicular leg pain with or without axial back pain of \>1 month duration
ā. No epidural injections at treatment site within the last three months
ā. Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10)
ā. Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1
ā. 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
ā. Pregnant or breastfeeding patient
ā. Younger than 21 or older than 75 years
ā. Presenting with motor deficits
ā. Presenting with a baseline Oswestry Disability Index ā„ 41% (severe disability or worse)
ā. Presence of metal hardware within the lumbosacral spine
. History of spine surgery at the level of treatment.
ā. 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)
ā. Severe lumbar central canal stenosis (greater than 50%)