Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Not Applicable

Recruiting

• Conditions: Lumbosacral Radiculopathy; Lumbar Radiculopathy

• Registration Number: NCT06924853
• Lead Sponsor: Regenexx, LLC

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) epidural injections for patients with lumbar radiculopathy.

Prior to enrollment, patients will undergo evaluation of medical history, back pain history, lumbar examination, radicular symptoms, medication use and review lumbar spine imaging.

Treatment will consist of lumbar transforaminal epidural at affected level/side. On the morning of the procedure, all patients will undergo a blood draw to maintain blinding of study condition. Patients in the active treatment group will receive an epidural injection of platelet lysate. Patients in the control group will receive an epidural injection of saline.

Patients will be blinded to study condition until the 3-month post-treatment follow-up. After completing the 3-month surveys, the patients will be unblinded. Patients that had been in the saline control group will be given the opportunity to cross-over into the active treatment group and re-start study timeline, completing follow-up surveys at 1, 2, 3- and 6- months.

The primary objective of this study is to compare the changes in patient-reported outcomes between the 2 groups (control versus treatment) for leg pain. Secondary objectives include comparing the change scores of other patient reported outcomes of back pain and function at 3-months, as well as continued evaluation of efficacy and durability up to 6-months in active treatment group. Change scores will be calculated by taking the difference between the 3-month scores and the baseline scores. Patients will complete subject-reported clinical questionnaires at pre-treatment, 1-month, 2-months, 3-months, and 6-months (6-m questionnaires only in the active treatment group).

Study Timeline

• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-11
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Numeric Pain Scale (NPS)-Leg	3-months	Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain in regard to leg pain

Secondary Outcome Measures

Name	Time	Method
Mean modified SANE scores	Baseline, 1-month, 2-month, 3-month, 6-month	Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved
Pain medications	Baseline and 3-months	Changes in medications from pre to post treatment
Numeric Pain Scale (NPS)-Leg	Baseline, 1-month, 2-month, 3-month, 6-month	Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Numeric Pain Scale (NPS)-Back	Baseline, 1-month, 2-month, 3-month, 6-month	Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Functional Rating Index (FRI)	Baseline, 1-month, 2-month, 3-month, 6-month	Changes in FRI from pre to post treatment and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very severe disability
Oswestry Disability Index (ODI)	Baseline, 1-month, 2-month, 3-month, 6-month	Changes in ODI from pre to post and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very disabled.
Patient Global Impression of Change (PGIC)	1-month, 2-month, 3-month, 6-month	Evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status (From "Very Much Improved" to "Very Much Worse")
Patient Global Impression of Severity (PGIS)	Baseline	Evaluate the severity of your overall health status (From "None" to "Very Severe"
Incidence rate of adverse events	1-month, 2-month, 3-month, 6-month	Incidence of adverse events after treatment
Incidence rate of surgical/other treatment interventions	1-month, 2-month, 3-month, 6-month	Incidence of surgical/other treatment interventions after treatment

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Broomfield, Colorado, United States