The MOTION Study - Treatment of LSS With the MILD Procedure

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.