Platelet Lysate vs Saline for Lumbosacral Radiculopathy (NCT06924853) | Clinical Trial Compass
TerminatedNot Applicable
Platelet Lysate vs Saline for Lumbosacral Radiculopathy
Stopped: Slow enrollment
United States2 participantsStarted 2025-07-01
Plain-language summary
This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Must be 18-65 years of age, inclusive, at time of signing informed consent
✓. At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
✓. Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit
✓. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
✓. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
✓. LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs.
✓. Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI.
✓. Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
Exclusion criteria
✕. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
✕. Currently taking anticoagulant or immunosuppressive medication
✕. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
✕. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
✕. Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments
✕. Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT
✕. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)