Disc Degeneration, Herniated Disc, Radiculopathy
Conditions
Keywords
Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration
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.
Interventions
PROCEDURERegenexx PL-Disc
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
PROCEDURESteroid Epidural
Injection into the epidural space under image guidance of 3 mg of betamethasone.
Sponsors
Regenexx, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Incidence of re-injection/re-operation | 12 months | Incidence of re-injection and surgical operation between treatment groups. |
Countries
United States
Outcome results
None listed