Status:
RECRUITING
Platelet Lysate vs Saline for Lumbosacral Radiculopathy
Lead Sponsor:
Regenexx, LLC
Conditions:
Lumbosacral Radiculopathy
Lumbar Radiculopathy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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).
Detailed Description
This single-center, single-blind, randomized-controlled clinical trial will enroll approximately 20 participants, randomized in a 1:1 ratio to receive either autologous PL (N=10) or saline (N=10) epid...
Eligibility Criteria
Inclusion
- 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.
- Voluntary signature of the IRB approved Informed Consent
Exclusion
- Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
- Bleeding disorders
- 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)
- Presence of spinal cord stimulator
- Received epidural steroid injection or nerve blocks within the last 2 months
- Use of chronic opioids
- Documented history of drug abuse within the last 6 months
- Use of immunosuppressants, oral or intravenous steroids in the last 3 months
- Is pregnant
- Allergy or intolerance to study medication (e.g. lidocaine, etc.)
- Condition represents a worker's comp case and/or is involved in health-related litigation
- Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study
- Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06924853
Start Date
July 1 2025
End Date
June 30 2026
Last Update
July 31 2025
Active Locations (1)
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1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021