Status:
TERMINATED
Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
Lead Sponsor:
Regenexx, LLC
Conditions:
Radiculopathy
Herniated Disc
Eligibility:
All Genders
18-65 years
Phase:
NA
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 t...
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 crossin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01850771
Start Date
May 1 2013
End Date
May 1 2016
Last Update
June 3 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021