Phase 4
N=38
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00995371 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Mean Change in VAS — 2.52; 0.06 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MILD® (Minimally Invasive Lumbar Decompression) (Device); Epidural Steroid Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coastal Orthopedics & Sports Medicine
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in VAS |
2.19; 1.00 | <0.05 sig |
| PRIMARY Mean Change in ODI |
16.13; 6.17 | <0.05 sig |
| PRIMARY Mean Change in VAS |
2.19; 1.00 | <0.05 sig |
| PRIMARY Mean Change in ODI |
16.13; 6.17 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00995371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.