Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

NCT ID: NCT01850771

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

Brief 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.

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.

Conditions

Radiculopathy; Herniated Disc; Disc Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Regenexx PL-Disc

Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.

Group Type: ACTIVE_COMPARATOR

Regenexx PL-Disc

Intervention Type: PROCEDURE

Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.

Steroid Epidural

Injection of steroid into the epidural space once a week for two weeks

Group Type: ACTIVE_COMPARATOR

Steroid Epidural

Intervention Type: PROCEDURE

Injection into the epidural space under image guidance of 3 mg of betamethasone.

Interventions

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.

Intervention Type: PROCEDURE

Steroid Epidural

Injection into the epidural space under image guidance of 3 mg of betamethasone.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenexx, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Centeno, MD

Role: PRINCIPAL_INVESTIGATOR

Centeno-Schultz Clinic

Locations

Centeno-Schultz Clinic

Broomfield, Colorado, United States

Countries

United States

Other Identifiers

RSI2013-RCT02

Identifier Type: -

Identifier Source: org_study_id