Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) ⦠(NCT00995371) | Clinical Trial Compass
CompletedPhase 4
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (MildĀ®) in Patients With Symptomatic Lumbar Central Canal Stenosis
United States38 participantsStarted 2009-08
Plain-language summary
This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILDĀ® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.ā¦
What they're measuring
1
Mean Change in VAS
Timeframe: Baseline and 6 weeks prior to cross-over
2
Mean Change in ODI
Timeframe: Baseline and 6 weeks prior to cross-over
3
Mean Change in VAS
Timeframe: Baseline and 26 weeks After ESI to mild cross-over
4
Mean Change in ODI
Timeframe: Baseline and 26 weeks After ESI to mild cross-over