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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995371
• Other study ID #: VMD001LB
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2009
• Last updated: September 13, 2013
• Start date: August 2009
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Coastal Orthopedics & Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• MILD® (Minimally Invasive Lumbar Decompression)
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.

Drug:
• Epidural Steroid Injection
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Locations

Country	Name	City	State
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Coastal Orthopedics & Sports Medicine	Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No