Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

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

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.

Study Overview

• Status: Terminated
• Conditions: Radiculopathy; Herniated Disc; Disc Degeneration
• Intervention / Treatment: Procedure: Regenexx PL-Disc; Procedure: Steroid Epidural

Detailed 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Broomfield, Colorado, United States, 80021
      • Centeno-Schultz Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regenexx, LLC
• Investigators: Principal Investigator: Christopher Centeno, MD, Centeno-Schultz Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Lumbar Radiculopathy; Disc bulge; Disc herniation; Disc degeneration
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Radiculopathy
• Other Study ID Numbers: RSI2013-RCT02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No