Clinical trial NCT01850771: Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
Official title: A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radiculopathy
Herniated Disc
Disc Degeneration
Keywords: Lumbar Radiculopathy
Disc bulge
Disc herniation
Disc degeneration
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry Disability Index Change from Baseline
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Mean Functional Rating Index Scores
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Mean ODI scores
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Mean Pain Scales
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Incidence of Complications and Adverse Events
timeFrame: 12 months
measure: Incidence of re-injection/re-operation
timeFrame: 12 months
measure: Use of pain medications
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: Time to Resolution of Complications and Adverse Events
timeFrame: 12 months
measure: Time to re-injection/re-operation
timeFrame: 12 months
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
Study officials:
affiliation: Centeno-Schultz Clinic
name: Christopher Centeno, MD
role: PRINCIPAL_INVESTIGATOR
References: