RECRUITING

Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Conditions

Lumbosacral Radiculopathy Lumbar Radiculopathy lumbosacral radicular pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).

Official Title

Single-Blind, Randomized, Controlled, Crossover Study of Autologous Platelet Lysate Versus Saline in Adults With Lumbosacral Radiculopathy

Quick Facts

Study Start:2025-07-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06924853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Must be 18-65 years of age, inclusive, at time of signing informed consent 2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS) 3. 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 4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes 5. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities. 6. 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. 7. 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. 8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits. 9. Voluntary signature of the IRB approved Informed Consent	1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain 2. Bleeding disorders 3. Currently taking anticoagulant or immunosuppressive medication 4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis) 5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.) 6. 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 7. 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 8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc) 9. Presence of spinal cord stimulator 10. Received epidural steroid injection or nerve blocks within the last 2 months 11. Use of chronic opioids 12. Documented history of drug abuse within the last 6 months 13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months 14. Is pregnant 15. Allergy or intolerance to study medication (e.g. lidocaine, etc.) 16. Condition represents a worker's comp case and/or is involved in health-related litigation 17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study 18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.

Inclusion Criteria

Exclusion Criteria

1. Must be 18-65 years of age, inclusive, at time of signing informed consent
2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
3. 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
4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
5. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
6. 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.
7. 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.
8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
9. Voluntary signature of the IRB approved Informed Consent

1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
2. Bleeding disorders
3. Currently taking anticoagulant or immunosuppressive medication
4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
6. 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
7. 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
8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)
9. Presence of spinal cord stimulator
10. Received epidural steroid injection or nerve blocks within the last 2 months
11. Use of chronic opioids
12. Documented history of drug abuse within the last 6 months
13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months
14. Is pregnant
15. Allergy or intolerance to study medication (e.g. lidocaine, etc.)
16. Condition represents a worker's comp case and/or is involved in health-related litigation
17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study
18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.

Contacts and Locations

Study Contact

Ehren Dodson, PhD

CONTACT

720-287-7199

edodson@regenexx.com

Matthew Murphy, PhD

CONTACT

mmurphy@regenexx.com

Study Locations (Sites)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021

United States

Collaborators and Investigators

Sponsor: Regenexx, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-07-01

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

lumbosacral radiculopathy
lumbosacral radicular pain
lumbar radiculopathy

Additional Relevant MeSH Terms

Lumbosacral Radiculopathy
Lumbar Radiculopathy