The MOTION Study - Treatment of LSS With the MILD Procedure

Running, not enrolling · Not applicable

Conditions studied: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

In brief

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.

Key facts

Study ID

NCT03610737

Run by

Vertos Medical, Inc.

People needed

155

Starts

2018-08-02

Expected to finish

2025-04-30

Last updated by the study team

2024-10-02

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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