The MOTION Study - Treatment of LSS With the MILD Procedure

Not Applicable

Active, not recruiting

Interventions: Device: MILD Procedure
Other: Conventional Medical Management (CMM)

Brief Summary: Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.

Detailed Description: The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.

Recruitment & Eligibility

Inclusion Criteria

Patients experiencing neurogenic claudication symptoms for at least 3 months duration.
LSS with neurogenic claudication
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 (Grade I without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
Stable opioid intake with no change during 30 days prior to enrollment.
Available to complete all follow-up visits.

Exclusion Criteria

ODI Score < 31 (0-100 ODI Scale).
NPRS Score < 5 (0-10 NPRS Scale).
Lumbar epidural injections during eight weeks prior to study enrollment.
Baseline analgesic medication greater than 90 milligram morphine equivalent (MME).
Prior surgery at the same treatment level.
Previously received interspinous spacer at the same treatment level.
Previously received intradiscal procedure at the same treatment level.
Previously received vertebral augmentation procedure at the same treatment level.
Previously received the MILD procedure at the same treatment level.
Received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment.
History of spinal fractures with current related pain symptoms.
Grade II 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.).
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.
Previously randomized and/or treated in this clinical study.
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.

Arm && Interventions

Group	Intervention	Description
MILD with CMM	MILD Procedure	The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD with CMM	Conventional Medical Management (CMM)	The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
CMM alone	Conventional Medical Management (CMM)	Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Primary Outcome Measures

Name	Time	Method
Mean Change in Oswestry Disability Index (ODI)	Mean Change in Oswestry Disability Index (ODI) baseline to 12 month	Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).

Secondary Outcome Measures

Name	Time	Method

Locations (18): Kansas Pain Management
🇺🇸
Overland Park, Kansas, United States
Interventional Pain Management Specialists
🇺🇸
Overland Park, Kansas, United States
The Center for Pain Relief
🇺🇸
Charleston, West Virginia, United States
Center for Pain Management
🇺🇸
Hackensack, New Jersey, United States
Newport Heache & Pain
🇺🇸
Newport Beach, California, United States
The Pain Management and Rehabilitation Center
🇺🇸
Seymour, Indiana, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Centura Spine Center
🇺🇸
Colorado Springs, Colorado, United States
Spine & Pain Institute of Florida
🇺🇸
Lakeland, Florida, United States
SIMED
🇺🇸
Ocala, Florida, United States
MI Interventional Pain Center
🇺🇸
Brownstown, Michigan, United States
Michigan Pain Specialists
🇺🇸
Ypsilanti, Michigan, United States
Roanoke-Chowan Pain Management
🇺🇸
Ahoskie, North Carolina, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Pennsylvania Pain & Spine Institute
🇺🇸
Chalfont, Pennsylvania, United States
Precision Spin Care
🇺🇸
Tyler, Texas, United States
UH St. John Pain Management Center
🇺🇸
Westlake, Ohio, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States