Clinical trial NCT06924853: Platelet Lysate vs Saline for Lumbosacral Radiculopathy
Official title: Single-Blind, Randomized, Controlled, Crossover Study of Autologous Platelet Lysate Versus Saline in Adults With Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbosacral Radiculopathy
Lumbar Radiculopathy
Keywords: lumbosacral radiculopathy
lumbosacral radicular pain
lumbar radiculopathy
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2025-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients are randomized either to active treatment or control group. Patients in control group can crossover to treatment group after 3-month time point.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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 1 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. For participants with both leg and back pain, the leg pain must be worse than the back pain.
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.

Primary outcomes:
measure: Numeric Pain Scale (NPS)-Leg
timeFrame: 3-months
Secondary outcomes:
measure: Numeric Pain Scale (NPS)-Leg
timeFrame: Baseline, 1-month, 2-month, 3-month, 6-month
measure: Numeric Pain Scale (NPS)-Back
timeFrame: Baseline, 1-month, 2-month, 3-month, 6-month
measure: Mean modified SANE scores
timeFrame: Baseline, 1-month, 2-month, 3-month, 6-month
measure: Functional Rating Index (FRI)
timeFrame: Baseline, 1-month, 2-month, 3-month, 6-month
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 1-month, 2-month, 3-month, 6-month
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1-month, 2-month, 3-month, 6-month
measure: Patient Global Impression of Severity (PGIS)
timeFrame: Baseline
measure: Incidence rate of adverse events
timeFrame: 1-month, 2-month, 3-month, 6-month
measure: Incidence rate of surgical/other treatment interventions
timeFrame: 1-month, 2-month, 3-month, 6-month
measure: Pain medications
timeFrame: Baseline and 3-months
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
Study officials:
References:
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citation: Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.
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citation: Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.