Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Radiculopathy Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disc Degeneration
• Herniated Disc
• Intervertebral Disc Degeneration
• Radiculopathy

• NCT number: NCT01850771
• Study type: Interventional
• Source: Regenerative Sciences, LLC
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Completion date: May 2016