Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationNCT02093520
The MiDAS ENCORE Study
A study testing MILD Procedure and Epidural Steroid Injection in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Vertos Medical, Inc. at 12 sites in United States.
Trial summary
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
- What is being tested?
- MILD Procedure and Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2014to Oct 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older and a Medicare beneficiary.
- Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
- LSS with neurogenic claudication diagnosed via:
- Symptomatic diagnosis and
- Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum >2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
- Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
- Available to complete 6 month and one year follow-up visits.
Who cannot join
- ODI Score < 31 (0-100 ODI Scale).
- NPRS Score < 5 (0-10 NPRS Scale).
- Prior surgery at any treatment level.
- History of recent spinal fractures with current related pain symptoms.
- Patients with Grade III or higher spondylolisthesis.
- Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Show all 12Show fewer
- Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
- Patients previously randomized and/or treated in this clinical study.
- Patients that have previously received the MILD procedure.
- ESI during eight weeks prior to study enrollment.
- Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
- On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Millennium Pain Center
Bloomington, Illinois, 61701
MI Interventional Pain Center
Cherry Island, Michigan, 48183
Synovation Medical Group
Chula Vista, California, 91914
Frankfort Pain Clinic
Frankfort, Kentucky, 40601
Spine Intervention Medical Group/Fresno Surgical Hospital
Fresno, California, 93710
Southern Spine Institute
Mt. Pleasant, South Carolina, 29464
The Spine Institute
Murrieta, California, 92563
SC Spine and Pain Specialists
Myrtle Beach, South Carolina, 29572
Newport Beach Headache and Pain
Newport Beach, California, 92660
Mayo Clinic Pain Management
Rochester, Minnesota, 55905
Premier Pain
Shrewsbury, New Jersey, 07702
Michigan Pain Specialist
Ypsilanti, Michigan, 48198
About this study
Official title: MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
- Being tested
- MILD Procedure, Epidural Steroid Injection
- Keywords
- Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication
- 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 ProcedureProcedure or surgery
Also called MILD lumbar decompression
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Epidural Steroid InjectionDrug
Also called ESI
Injection of epidural steroids into the lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| MILD | Active comparator | The MILD procedure is an image-guided minimally-invasive lumbar decompression Receives: Procedure: MILD Procedure |
| Epidural Steroid Injection (ESI) | Active comparator | An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine. Receives: Drug: Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
Measured: 12 months
Secondary outcomes (2)
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Measured: 12 months
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionOct 2017
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 (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertos Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramsin Benyamin, MD, Principal investigator, AAPM; ASIPP; ISIS; ASAPeter Staats, MD, Principal investigator, AAPM; ASIPP; ASA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093520
- Sponsor's protocol ID
- MiDAS ENCORE
- Status last verified
- May 2017
- First submitted
- 18 Mar 2014
- Last updated
- 6 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868.
PubMed 30199512Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42.
PubMed 27228511Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38.
PubMed 26815247
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
- ClinicalTrials.gov ID
- NCT02093520
- Acronym / sponsor ID
- MiDAS ENCORE
- Keywords
- Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Vertos Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MILD | Active comparator | Procedure: MILD ProcedureThe MILD procedure is an image-guided minimally-invasive lumbar decompression |
| Epidural Steroid Injection (ESI) | Active comparator | Drug: Epidural Steroid InjectionAn epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65 years or older and a Medicare beneficiary.
- Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
- LSS with neurogenic claudication diagnosed via:
- Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
- Available to complete 6 month and one year follow-up visits.
Key exclusion criteria (12 listed)
- ODI Score < 31 (0-100 ODI Scale).
- NPRS Score < 5 (0-10 NPRS Scale).
- Prior surgery at any treatment level.
- History of recent spinal fractures with current related pain symptoms.
- Patients with Grade III or higher spondylolisthesis.
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 ProcedureAlso: MILD lumbar decompressionThe percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. | Procedure or surgery | MILD |
| Epidural Steroid InjectionAlso: ESIInjection of epidural steroids into the lumbar spine | Drug | Epidural Steroid Injection (ESI) |
Primary outcome
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Time frame: 12 months
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
2 secondary outcomes
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Time frame: 12 months
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30199512Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868.
- Derived from this study: PubMed 27228511Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42.
- Derived from this study: PubMed 26815247Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38.
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.
Ramsin Benyamin, MD principal investigator
AAPM; ASIPP; ISIS; ASA
Peter Staats, MD principal investigator
AAPM; ASIPP; ASA
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILD Procedure and Epidural Steroid Injection in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Vertos Medical, Inc. at 12 sites in United States.
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 7 inclusion and 12 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2017). 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?
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months (time frame: 12 months). 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 NCT02093520, which also lists 3 linked publications.
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 6 Dec 2017; AzTrials last refreshed its copy on 28 Oct 2026.