Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Study of Epidural Steroid Injection Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
Brief Summary: This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.


Options:
A: Inclusion Criteria:

* Imaging evidence of stenosis
* Unable to walk more than 1/4 of a mile
* No prior surgery for stenosis
* Consents to surgery
* Speaks English

Exclusion Criteria:

* Presence of dementia or organic brain syndrome
* Coronary artery disease, recent myocardial infarction, pulmonary or vascular disease
* Spondylolisthesis (\> 5 mm slippage)
* Severe osteoporosis
* Metastatic cancer
B: Inclusion Criteria:

* Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
* Prior failure of conservative therapy and ODI Score \>20%.
* Radiologic evidence of LSS (L3-L5), Ligamentum flavum \>2.5mm, confirmed by pre-op MRI and/or CT.
* Central canal cross sectional area ≤ 100 square mm.
* Anterior listhesis ≤ 5.0mm.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 26 weeks of follow-up.
* A signed Informed Consent Form is obtained from the patient.
* Adults at least 18 years of age.

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of recent spinal fractures with concurrent pain symptoms.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)
* Significant / symptomatic disc protrusion or osteophyte formation.
* Excessive / symptomatic facet hypertrophy.
* Bleeding disorders and/or current use of anti-coagulants.
* Use of ASA and/or NSAID within 5 days of treatment.
* Pregnant and/or breastfeeding.
* Epidural steroids previously administered (not ESI naive)
* Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
* Dementia and/or inability to give informed consent.
* Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).
* On Workman's Compensation or considering litigation associated with back pain.
C: Inclusion Criteria:

* Duration of Symptoms: 12 or more weeks.
* Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy.
* Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
* Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

* Previous lumbar spine surgery.
* Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
* Possible pregnancy.
* Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
* Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
* Age less than 18 years.
* Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
* Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
* Symptoms less than 12 weeks.
* Patient currently enrolled in any experimental "spine related" study.
D: Inclusion Criteria:

* Duration of Symptoms: 12 or more weeks.
* Treatments Tried: Nonsteroidal. anti-inflammatory medical therapy and physical therapy.
* Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
* Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

* Previous lumbar spine surgery.
* Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
* Possible pregnancy.
* Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
* Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
* Age less than 18 years.
* Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
* Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
* Symptoms less than 12 weeks.
* Patient currently enrolled in any experimental "spine related" study.

Answer: B