The use of lumbar epidural injection of platelet lysate for treatment of radicular pain

Christopher Centeno, Jason Markle, Ehren Dodson, Ian Stemper, Matthew Hyzy, Christopher Williams, Michael Freeman, Christopher Centeno, Jason Markle, Ehren Dodson, Ian Stemper, Matthew Hyzy, Christopher Williams, Michael Freeman

Abstract

Background: Epidural steroid injections (ESI) are the most common pain management procedure performed in the US, however evidence of efficacy is limited. In addition, there is early evidence that the high dose of corticosteroids used can have systemic side effects. We describe the results of a case series evaluating the use of platelet lysate (PL) epidural injections for the treatment of lumbar radicular pain as an alternative to corticosteroids.

Methods: Registry data was obtained for patients (N = 470) treated with PL epidural injections presenting with symptoms of lumbar radicular pain and MRI findings that were consistent with symptoms. Collected outcomes included numeric pain score (NPS), functional rating index (FRI), and a modified single assessment numeric evaluation (SANE) rating.

Results: Patients treated with PL epidurals reported significantly lower (p < .0001) NPS and FRI change scores at all time points compared to baseline. Post-treatment FRI change score means exceeded the minimal clinically important difference beyond 1 month. Average modified SANE ratings showed 49.7% improvement at 24 months post-treatment. Twenty-nine (6.3%) patients reported mild adverse events related to treatment.

Conclusion: Patients treated with PL epidurals reported significant improvements in pain, exceeded the minimal clinically important difference (MCID) for FRI, and reported subjective improvement through 2-year follow-up. PL may be a promising substitute for corticosteroid.

Keywords: Back pain; Corticosteroids; Lumbar; Platelet lysate; Radicular; Regenerative; Spine; Steroids.

Conflict of interest statement

Ethics approval and consent to participate

Patients provided verbal and written consent. The International Cellular Medicine Society provided IRB oversight and approval (OHRP Registration #IRB00002637). Trial registration number: NCT03011398; A Clinical Registry of Orthobiologics Procedures.

Consent for publication

All patients provided consent for publication.

Competing interests

CC is a shareholder and CMO of Regenexx, LLC and president and owner of the Centeno-Schultz Clinic. JM, ED, IS, CW, MH and MF have declared no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study inclusion flow chart
Fig. 2
Fig. 2
Adverse events reported. Adverse events (AE) related to the procedure were reported by 6.2% of patients. Of those 79.3% were categorized as pain related, 10.3% were dural puncture-related and 10.3% were skin reactions. *The percentage of patients without an AE related to the procedure
Fig. 3
Fig. 3
NPS average change scores. Numeric pain score (NPS) average change from baseline to post-treatment with standard deviation. Number of patients reporting at each time point: 1-month (N = 139); 3-month (N = 192); 6-month (N = 181); 12-month (N = 174); 18-month (N = 143); 24-month (N = 126). Statistical comparisons are to baseline. **p < .0001
Fig. 4
Fig. 4
Modified SANE ratings tier plot. The percent of total patients at each post-treatment time point reporting feeling better (modified SANE > 0), no change (modified SANE = 0), or worse (modified SANE N = 128); 3-month (N = 211), 6-month (N = 216), 12-month (N = 203), 18-month (N = 153), 24-month (N = 129)
Fig. 5
Fig. 5
FRI average change scores. Functional rating index (FRI) averaged change in scores from baseline at each post-treatment time point with standard deviation. The number of patients reporting at each time point: 1-month (N = 111); 3-month (N = 144), 6-month (N = 146), 12-month (N = 136), 18-month (N = 114), 24-month (N = 100). **p < .0001

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