Clinical trial NCT02093520: The MiDAS ENCORE Study
Official title: MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords: Lumbar Spinal Stenosis
Spinal Stenosis
Neurogenic Claudication
Lead sponsor: Vertos Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 302
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 65 years or older and a Medicare beneficiary.
2. 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.
3. LSS with neurogenic claudication diagnosed via:

   1. Symptomatic diagnosis and
   2. 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.
4. 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.
5. Available to complete 6 month and one year follow-up visits.

Exclusion Criteria:

1. ODI Score \< 31 (0-100 ODI Scale).
2. NPRS Score \< 5 (0-10 NPRS Scale).
3. Prior surgery at any treatment level.
4. History of recent spinal fractures with current related pain symptoms.
5. Patients with Grade III or higher spondylolisthesis.
6. 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.).
7. 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.
8. Patients previously randomized and/or treated in this clinical study.
9. Patients that have previously received the MILD procedure.
10. ESI during eight weeks prior to study enrollment.
11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.

Primary outcomes:
measure: Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
timeFrame: 12 months
measure: Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Synovation Medical Group
state: California
city: Fresno
country: United States
facility: Spine Intervention Medical Group/Fresno Surgical Hospital
state: California
city: Murrieta
country: United States
facility: The Spine Institute
state: California
city: Newport Beach
country: United States
facility: Newport Beach Headache and Pain
state: California
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Frankfort
country: United States
facility: Frankfort Pain Clinic
state: Kentucky
city: Brownstown Charter Township
country: United States
facility: MI Interventional Pain Center
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Pain Specialist
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Pain Management
state: Minnesota
city: Shrewsbury
country: United States
facility: Premier Pain
state: New Jersey
city: Mount Pleasant
country: United States
facility: Southern Spine Institute
state: South Carolina
city: Myrtle Beach
country: United States
facility: SC Spine and Pain Specialists
state: South Carolina
Study officials:
affiliation: AAPM; ASIPP; ISIS; ASA
name: Ramsin Benyamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AAPM; ASIPP; ASA
name: Peter Staats, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Benyamin 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.
citation: Staats 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.