CompletedPhase 4

Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) 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 MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Who can participate

Age range

18 Years

Sex

ALL

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.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in VAS

Timeframe: Baseline and 6 weeks prior to cross-over

Mean Change in ODI

Timeframe: Baseline and 6 weeks prior to cross-over

Mean Change in VAS

Timeframe: Baseline and 26 weeks After ESI to mild cross-over

Mean Change in ODI

Timeframe: Baseline and 26 weeks After ESI to mild cross-over

Trial details

NCT IDNCT00995371

SponsorCoastal Orthopedics & Sports Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06

Results submitted2013-07-02

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change in VAS

Timeframe: Baseline and 6 weeks prior to cross-over

Mean Change in ODI

Timeframe: Baseline and 6 weeks prior to cross-over

Mean Change in VAS

Timeframe: Baseline and 26 weeks After ESI to mild cross-over

Mean Change in ODI

Timeframe: Baseline and 26 weeks After ESI to mild cross-over