Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Not Applicable

Terminated

• Conditions: Disc Degeneration; Radiculopathy; Herniated Disc

• Registration Number: NCT01850771
• Lead Sponsor: Regenexx, LLC

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index Change from Baseline	Change from baseline to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Mean ODI scores	6 weeks, 3 months, 6 months, 12 months	Difference between treatment groups in mean ODI scores at each follow-up timepoint
Mean Pain Scales	6 weeks, 3 months, 6 months, 12 months	Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
Incidence of Complications and Adverse Events	12 months	Incidence of post-operative complications and adverse events between treatment groups.
Use of pain medications	6 weeks, 3 months, 6 months, 12 months	Difference between treatment groups in use of pain medications at each follow-up timepoint
Time to Resolution of Complications and Adverse Events	12 months	Time to resolution of post-operative complications and adverse events between treatment groups.
Time to re-injection/re-operation	12 months	Time to re-injection and surgical operation between treatment groups.
Mean Functional Rating Index Scores	6 weeks, 3 months, 6 months, 12 months	Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.
Incidence of re-injection/re-operation	12 months	Incidence of re-injection and surgical operation between treatment groups.

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Broomfield, Colorado, United States