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Platelet Lysate vs Saline for Lumbosacral Radiculopathy

NCT06924853 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-02-25

No results posted yet for this study

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).

Conditions

  • Lumbosacral Radiculopathy
  • Lumbar Radiculopathy

Interventions

OTHER

Platelet lysate

The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis (Beckman Coulter DxH 500 Series). Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. Once flow is confirmed, the physician will inject 4mL of the PL, and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. A 0.22 micron filter will be used.

OTHER

Saline control

The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis; same as active treatment to maintain blinding. Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. (6) Once flow is confirmed, the physician will inject 4mL of sterile saline (0.9%), and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest.

Sponsors & Collaborators

  • Regenexx, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-11-05
Completion
2025-11-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924853 on ClinicalTrials.gov