Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
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|ClinicalTrials.gov Identifier: NCT01850771|
Recruitment Status : Terminated (Difficulties in recruitment)
First Posted : May 9, 2013
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Radiculopathy Herniated Disc Disc Degeneration||Procedure: Regenexx PL-Disc Procedure: Steroid Epidural||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Regenexx PL-Disc
Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.
Procedure: Regenexx PL-Disc
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
Active Comparator: Steroid Epidural
Injection of steroid into the epidural space once a week for two weeks
Procedure: Steroid Epidural
Injection into the epidural space under image guidance of 3 mg of betamethasone.
- Oswestry Disability Index Change from Baseline [ Time Frame: Change from baseline to 3 months ]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.
- Mean Functional Rating Index Scores [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.
- Mean ODI scores [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]Difference between treatment groups in mean ODI scores at each follow-up timepoint
- Mean Pain Scales [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
- Incidence of Complications and Adverse Events [ Time Frame: 12 months ]Incidence of post-operative complications and adverse events between treatment groups.
- Incidence of re-injection/re-operation [ Time Frame: 12 months ]Incidence of re-injection and surgical operation between treatment groups.
- Use of pain medications [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]Difference between treatment groups in use of pain medications at each follow-up timepoint
- Time to Resolution of Complications and Adverse Events [ Time Frame: 12 months ]Time to resolution of post-operative complications and adverse events between treatment groups.
- Time to re-injection/re-operation [ Time Frame: 12 months ]Time to re-injection and surgical operation between treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850771
|United States, Colorado|
|Broomfield, Colorado, United States, 80021|
|Principal Investigator:||Christopher Centeno, MD||Centeno-Schultz Clinic|