Lumbosacral Radiculopathy, Lumbar Radiculopathy
Conditions
Keywords
lumbosacral radiculopathy, lumbosacral radicular pain, lumbar radiculopathy
Brief summary
This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).
Detailed description
This single-center, single-blind, randomized-controlled clinical trial will enroll approximately 20 participants, randomized in a 1:1 ratio to receive either autologous PL (N=10) or saline (N=10) epidural injections for patients with lumbar radiculopathy. Prior to enrollment, patients will undergo evaluation of medical history, back pain history, lumbar examination, radicular symptoms, medication use and review lumbar spine imaging. Treatment will consist of lumbar transforaminal epidural at affected level/side. On the morning of the procedure, all patients will undergo a blood draw to maintain blinding of study condition. Patients in the active treatment group will receive an epidural injection of platelet lysate. Patients in the control group will receive an epidural injection of saline. Patients will be blinded to study condition until the 3-month post-treatment follow-up. After completing the 3-month surveys, the patients will be unblinded. Patients that had been in the saline control group will be given the opportunity to cross-over into the active treatment group and re-start study timeline, completing follow-up surveys at 1, 2, 3- and 6- months. The primary objective of this study is to compare the changes in patient-reported outcomes between the 2 groups (control versus treatment) for leg pain. Secondary objectives include comparing the change scores of other patient reported outcomes of back pain and function at 3-months, as well as continued evaluation of efficacy and durability up to 6-months in active treatment group. Change scores will be calculated by taking the difference between the 3-month scores and the baseline scores. Patients will complete subject-reported clinical questionnaires at pre-treatment, 1-month, 2-months, 3-months, and 6-months (6-m questionnaires only in the active treatment group).
Interventions
OTHERPlatelet lysate
The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis (Beckman Coulter DxH 500 Series). Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. Once flow is confirmed, the physician will inject 4mL of the PL, and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. A 0.22 micron filter will be used.
OTHERSaline control
The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis; same as active treatment to maintain blinding. Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. (6) Once flow is confirmed, the physician will inject 4mL of sterile saline (0.9%), and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest.
Sponsors
Regenexx, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Patients are randomized either to active treatment or control group. Patients in control group can crossover to treatment group after 3-month time point.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Must be 18-65 years of age, inclusive, at time of signing informed consent 2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS) 3. Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit 4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes 5. Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities. 6. LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs. 7. Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI. 8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits. 9. Voluntary signature of the IRB approved Informed Consent
Exclusion criteria
1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain 2. Bleeding disorders 3. Currently taking anticoagulant or immunosuppressive medication 4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis) 5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.) 6. Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments 7. Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT 8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc) 9. Presence of spinal cord stimulator 10. Received epidural steroid injection or nerve blocks within the last 2 months 11. Use of chronic opioids 12. Documented history of drug abuse within the last 6 months 13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months 14. Is pregnant 15. Allergy or intolerance to study medication (e.g. lidocaine, etc.) 16. Condition represents a worker's comp case and/or is involved in health-related litigation 17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study 18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale (NPS)-Leg | 3-months | Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain in regard to leg pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Scale (NPS)-Back | Baseline, 1-month, 2-month, 3-month, 6-month | Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain |
| Mean modified SANE scores | Baseline, 1-month, 2-month, 3-month, 6-month | Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved |
| Functional Rating Index (FRI) | Baseline, 1-month, 2-month, 3-month, 6-month | Changes in FRI from pre to post treatment and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very severe disability |
| Oswestry Disability Index (ODI) | Baseline, 1-month, 2-month, 3-month, 6-month | Changes in ODI from pre to post and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very disabled. |
| Patient Global Impression of Change (PGIC) | 1-month, 2-month, 3-month, 6-month | Evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status (From "Very Much Improved" to "Very Much Worse") |
| Patient Global Impression of Severity (PGIS) | Baseline | Evaluate the severity of your overall health status (From "None" to "Very Severe" |
| Incidence rate of adverse events | 1-month, 2-month, 3-month, 6-month | Incidence of adverse events after treatment |
| Incidence rate of surgical/other treatment interventions | 1-month, 2-month, 3-month, 6-month | Incidence of surgical/other treatment interventions after treatment |
| Numeric Pain Scale (NPS)-Leg | Baseline, 1-month, 2-month, 3-month, 6-month | Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain |
| Pain medications | Baseline and 3-months | Changes in medications from pre to post treatment |
Countries
United States
Outcome results
None listed