Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | May 2017 |
A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
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.
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.
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.
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.
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
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