Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: MILD® (Minimally Invasive Lumbar Decompression); Drug: Epidural Steroid Injection

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vertos mild® Minimally-Invasive Lumbar Decompression; Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.	Device: MILD® (Minimally Invasive Lumbar Decompression); Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Active Comparator: Epidural Steroid Injection; Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.	Drug: Epidural Steroid Injection; An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in VAS	Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.	Baseline and 6 weeks prior to cross-over
Mean Change in ODI	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value	Baseline and 6 weeks prior to cross-over
Mean Change in VAS	Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.	Baseline and 26 weeks After ESI to mild cross-over
Mean Change in ODI	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value	Baseline and 26 weeks After ESI to mild cross-over

Collaborators and Investigators

• Sponsor: Coastal Orthopedics & Sports Medicine
• Collaborators: Vertos Medical, Inc.
• Investigators: Principal Investigator: Lora Brown, MD, Coastal Orthopedics & Sports Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Spinal Stenosis; Lumbar Spinal Stenosis; Laminotomy; Laminectomy; Spine Surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: VMD001LB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No