Sterile Amniotic Fluid Filtrate Epidural Injection.
Lumbar Spinal Stenosis
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Amniotic Fluid, Epidural Injection
Eligibility Criteria
Inclusion Criteria:
- Patients who are ≥ 18 years old
- Pain in the low back and lower extremity (pain NRS >4) with buttock/leg pain > back pain.
- Radicular distribution of leg pain based on history and correlation with advancing imaging. Radicular pain may be fixed or claudicatory in nature.
- Pain resistant to a trial of conservative therapy (i.e. oral steroids, NSAIDs, opioids, muscle relaxants, physical therapy, chiropractic or other non-invasive care) for at least 3 months.
- Mild-moderate-severe lumbar foraminal or subarticular zone stenosis, and/or mild-moderate central canal spinal stenosis identified by MRI or CT scan according to radiologic criteria (Boden 1996).
- Ability to read English and complete the assessment questionnaires.
- Must have been 90 days since last steroid injection.
Exclusion Criteria:
- Patients in the opinion of the treating investigator who are unwilling or unable to comply with study procedures.
- Systemic infection or local infection over planned injection site.
- Bleeding disorder, current use of anticoagulants or anti-platelet medications.
- Intrinsic spinal cord lesions.
- History of central neurologic, cerebrovascular, demyelinating or muscular disease.
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within the last 6 months).
- Allergy to medications being used for injection procedures.
- Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.
- Cognitive deficit or motor neuron disease.
- Spinal instability requiring surgery.
- History of spinal fusion surgery
- Metastatic cancer.
- Concordant pain with internal rotation of the hip (or known hip joint pathology)
Sites / Locations
- University of Utah Orthopaedic CenterRecruiting
- University of Utah Orthopaedic CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Transforaminal epidural Amniotic Fluid injection
Transforaminal epidural dexamethasone injection
Using fluoroscopic guidance, a lumbosacral epidural injection will be performed. 2-5cc of 1% lidocaine will be injected into the skin and subcutaneous tissue to anesthetize the skin and subcutaneous structures over the site of planned entry to the neural foramen. A 22 or 25 g Whitacre needle (3.5-7") will be used to access the epidural space using the sub-pedicular or infraneural transforaminal approach, depending on individual anatomy at the discretion of the treating physician. Needle tip position will be confirmed using anterior-posterior and lateral fluoroscopic views as well as with injection of a standard 1-3 mL aliquot of omnipaque 180 (Iohexol) (GE Healthcare) contrast material during live fluoroscopy to confirm epidural flow of contrast and to rule out an intravascular injection. Then 3 mL of Amniotic Fluid will be injected through the spinal needle for unilateral symptoms, for a total injection volume of 3 mL in both groups.
Using fluoroscopic guidance, a lumbosacral epidural injection will be performed. 2-5cc of 1% lidocaine will be injected into the skin and subcutaneous tissue to anesthetize the skin and subcutaneous structures over the site of planned entry to the neural foramen. A 22 or 25 g Whitacre needle (3.5-7") will be used to access the epidural space using the sub-pedicular or infraneural transforaminal approach, depending on individual anatomy at the discretion of the treating physician. Needle tip position confirmed using anterior-posterior and lateral fluoroscopic views as well as with injection of a standard 1-3 mL aliquot of omnipaque 180 (Iohexol) (GE Healthcare) contrast material during live fluoroscopy to confirm epidural flow of contrast and to rule out an intravascular injection. 1 mL of dexamethasone sodium phosphate (10 mg/mL) combined with 2 mL of sterile water will be injected through the spinal needle for unilateral symptoms, for a total injection volume of 3 mL in both groups.