Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Regenexx

Status: Terminated

Conditions: Radiculopathy; Herniated Disc; Disc Degeneration

Treatments: Procedure: Regenexx PL-Disc; Procedure: Steroid Epidural

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850771

RSI2013-RCT02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

8 participants in 2 patient groups

Regenexx PL-Disc

Active Comparator group

Description:

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

Treatment:

Procedure: Regenexx PL-Disc

Steroid Epidural

Active Comparator group

Description:

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

Treatment:

Procedure: Steroid Epidural