Clinical trial NCT00995371: Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis
Lumbar Spinal Stenosis
Laminotomy
Laminectomy
Spine Surgery
Lead sponsor: Coastal Orthopedics & Sports Medicine
Sponsor class: OTHER
Collaborators: name: Vertos Medical, Inc.
First posted: 2009-10-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in VAS
timeFrame: Baseline and 6 weeks prior to cross-over
measure: Mean Change in ODI
timeFrame: Baseline and 6 weeks prior to cross-over
measure: Mean Change in VAS
timeFrame: Baseline and 26 weeks After ESI to mild cross-over
measure: Mean Change in ODI
timeFrame: Baseline and 26 weeks After ESI to mild cross-over
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Coastal Orthopedics & Sports Medicine
state: Florida
Study officials:
affiliation: Coastal Orthopedics & Sports Medicine
name: Lora Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild(R) procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012 Jun;12(5):333-41. doi: 10.1111/j.1533-2500.2011.00518.x. Epub 2012 Jan 25.