Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Study Overview
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Brief Summary
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The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Detailed Description
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Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months. Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination. Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group. Subjects will complete the study following the 1 year follow-up visit.

Official Title
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A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy

Conditions
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Radiculopathy, Herniated Disc, Disc Degeneration

Intervention / Treatment
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* Procedure: Regenexx PL-Disc
* Procedure: Steroid Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years Significant functional disability related to pain, lack of strength, or other back or leg symptoms Physical examination consistent with lumbar radiculopathy Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings Is independent, ambulatory, and can comply with all post-operative evaluations and visits Exclusion Criteria: Symptomatic central or foraminal stenosis Previous low back surgery Prior epidural steroid injection or other low back injection therapy within the past year >50% loss of disc height at the symptomatic level Spondylolisthesis Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) Quinolone or Statin induced myopathy/tendinopathy Severe neurogenic inflammation of the cutaneous nerves Condition represents a worker's compensation case Currently involved in a health-related litigation procedure Is pregnant Bleeding disorders Currently taking anticoagulant or immunosuppressive medication Allergy or intolerance to study medication Use of chronic opioid, Documented history of drug abuse within six months of treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regenexx PL-Disc<br>Injection of Regenexx PL-Disc into the epidural space once a week for two weeks. | Procedure: Regenexx PL-Disc<br>* Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.<br>|
| Active Comparator: Steroid Epidural<br>Injection of steroid into the epidural space once a week for two weeks | Procedure: Steroid Epidural<br>* Injection into the epidural space under image guidance of 3 mg of betamethasone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index Change from Baseline | The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Oswestry Disability Index (ODI) scores. | Change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Functional Rating Index Scores | Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint. | 6 weeks, 3 months, 6 months, 12 months | 
| Mean ODI scores | Difference between treatment groups in mean ODI scores at each follow-up timepoint | 6 weeks, 3 months, 6 months, 12 months | 
| Mean Pain Scales | Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint | 6 weeks, 3 months, 6 months, 12 months | 
| Incidence of Complications and Adverse Events | Incidence of post-operative complications and adverse events between treatment groups. | 12 months | 
| Incidence of re-injection/re-operation | Incidence of re-injection and surgical operation between treatment groups. | 12 months | 
| Use of pain medications | Difference between treatment groups in use of pain medications at each follow-up timepoint | 6 weeks, 3 months, 6 months, 12 months | 
| Time to Resolution of Complications and Adverse Events | Time to resolution of post-operative complications and adverse events between treatment groups. | 12 months | 
| Time to re-injection/re-operation | Time to re-injection and surgical operation between treatment groups. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration