Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Stopped early · Not applicable

Conditions studied: Radiculopathy, Herniated Disc, Disc Degeneration

In brief

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.

Key facts

Study ID

NCT01850771

Run by

Regenexx, LLC

People needed

8

Starts

2013-05-01

Expected to finish

2016-05-01

Last updated by the study team

2016-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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