Lumbar Spinal StenosisPhase 4NCT00995371

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

A Phase 4 study testing MILD® (Minimally Invasive Lumbar Decompression) and Epidural Steroid Injection in people with Lumbar Spinal Stenosis, run by Coastal Orthopedics & Sports Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lumbar Spinal Stenosis
What is being tested?: MILD® (Minimally Invasive Lumbar Decompression) and Epidural Steroid Injection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Aug 2009to May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209

Other trials in United States

About this study

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

Conditions: Lumbar Spinal Stenosis
Being tested: MILD® (Minimally Invasive Lumbar Decompression), Epidural Steroid Injection
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MILD® (Minimally Invasive Lumbar Decompression)Device
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Epidural Steroid InjectionDrug
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Study groups in NCT00995371
Study group	Role	What they receive
Vertos mild® Minimally-Invasive Lumbar Decompression	Active comparator	Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. Receives: Device: MILD® (Minimally Invasive Lumbar Decompression)
Epidural Steroid Injection	Active comparator	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. Receives: Drug: Epidural Steroid Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2013

First posted15 Oct 2009 (estimated)
Study startAug 2009
Primary completionJun 2012
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00995371
Sponsor's protocol ID: VMD001LB
Status last verified: Sep 2013
First submitted: 14 Oct 2009
Last updated: 15 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 22272730

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)

All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00995371
Acronym / sponsor ID: VMD001LB
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Coastal Orthopedics & Sports MedicineUniversity, hospital or other
Collaborators: Vertos Medical, Inc.
Study start: Aug 2009
Primary completion: Jun 2012 (actual)
Study completion: May 2013 (actual)
First posted: 15 Oct 2009 (estimated)
Results: Posted 15 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vertos mild® Minimally-Invasive Lumbar Decompression	Active comparator	Device: 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.
Epidural Steroid Injection	Active comparator	Drug: Epidural Steroid InjectionPatients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MILD® (Minimally Invasive Lumbar Decompression)Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.	Device	Vertos mild® Minimally-Invasive Lumbar Decompression
Epidural Steroid InjectionAn Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.	Drug	Epidural Steroid Injection

Primary outcome

Mean Change in VAS
Time frame: Baseline and 6 weeks prior to cross-over
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.
Mean Change in ODI
Time frame: Baseline and 6 weeks prior to cross-over
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
Mean Change in VAS
Time frame: Baseline and 26 weeks After ESI to mild cross-over
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.
Mean Change in ODI
Time frame: Baseline and 26 weeks After ESI to mild cross-over
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

Results and safety

Results posted to the registry on 15 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)	21	21
Epidural Steroid Injection Then Lumbar Decompression With Mild	17	17

Primary outcome: Mean Change in VAS

Time frame: Baseline and 6 weeks prior to cross-over. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n = 21	Epidural Steroid Injection Prior to Cross-Over n = 17
Value	2.52 (1.09 to 3.96)	0.06 (-1.43 to 1.55)

Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild): Mean Difference (Final Values): 2.52 (95% CI 1.09 to 3.96), p <0.05, t-test, 2 sided
Epidural Steroid Injection Prior to Cross-Over: Mean Difference (Final Values): 0.06 (95% CI -1.43 to 1.55), p >0.05, t-test, 2 sided

Population analysed: All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Primary outcome: Mean Change in ODI

Time frame: Baseline and 6 weeks prior to cross-over. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n = 21	Epidural Steroid Injection Prior to Cross-Over n = 17
Value	11.33 (3.35 to 19.31)	5.65 (-4.12 to 15.41)

Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild): Mean Difference (Final Values): 11.33 (95% CI 3.35 to 19.31), p <0.05, t-test, 2 sided
Epidural Steroid Injection Prior to Cross-Over: Mean Difference (Final Values): 5.65 (95% CI -4.12 to 15.41), p >0.05, t-test, 2 sided

Population analysed: All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.

Primary outcome: Mean Change in VAS

Time frame: Baseline and 26 weeks After ESI to mild cross-over. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n = 16	Epidural Steroid Injection Then Lumbar Decompression With Mild n = 12
Value	2.19 (0.61 to 3.77)	1.00 (-0.66 to 2.66)

Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild): Mean Difference (Final Values): 2.19 (95% CI 0.61 to 3.77), p <0.05, t-test, 2 sided
Epidural Steroid Injection Then Lumbar Decompression With Mild: Mean Difference (Final Values): 1.00 (95% CI -0.66 to 2.66), p >0.05, t-test, 2 sided

Population analysed: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Primary outcome: Mean Change in ODI

Time frame: Baseline and 26 weeks After ESI to mild cross-over. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild) n = 16	Epidural Steroid Injection Then Lumbar Decompression With Mild n = 12
Value	16.13 (7.43 to 24.83)	6.17 (-1.24 to 13.58)

Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild): Mean Difference (Final Values): 16.13 (95% CI 7.43 to 24.83), p <0.05, t-test, 2 sided
Epidural Steroid Injection Then Lumbar Decompression With Mild: Mean Difference (Final Values): 6.17 (95% CI -1.24 to 13.58), p >0.05, t-test, 2 sided

Population analysed: Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vertos Mild® Minimally-Invasive Lumbar Decompression	0 of 21 (0%)	0 of 21 (0%)	Not reported
Epidural Steroid Injection	0 of 17 (0%)	0 of 17 (0%)	Not reported
ESI Cross-over to Lumbar Decompression With Mild	0 of 17 (0%)	0 of 17 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22272730Brown 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.

Related trials for Lumbar Spinal Stenosis

RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lora Brown, MD principal investigator

Coastal Orthopedics & Sports Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in VAS (time frame: Baseline and 6 weeks prior to cross-over). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00995371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013; AzTrials last refreshed its copy on 7 Nov 2026.