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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
Injection into the epidural space under image guidance of 3 mg of betamethasone.
Centeno-Schultz Clinic
Broomfield, Colorado, United States
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.
Time frame: Change from baseline to 3 months
Mean Functional Rating Index Scores
Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.
Time frame: 6 weeks, 3 months, 6 months, 12 months
Mean ODI scores
Difference between treatment groups in mean ODI scores at each follow-up timepoint
Time frame: 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
Time frame: 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.
Time frame: 12 months
Incidence of re-injection/re-operation
Incidence of re-injection and surgical operation between treatment groups.
Time frame: 12 months
Use of pain medications
Difference between treatment groups in use of pain medications at each follow-up timepoint
Time frame: 6 weeks, 3 months, 6 months, 12 months
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Time to Resolution of Complications and Adverse Events
Time to resolution of post-operative complications and adverse events between treatment groups.
Time frame: 12 months
Time to re-injection/re-operation
Time to re-injection and surgical operation between treatment groups.
Time frame: 12 months