Clinical trial NCT03610737: The MOTION Study - Treatment of LSS With the MILD Procedure
Official title: A Multi-center, Randomized Controlled Study of the Vertos MILD Procedure With Conventional Medical Management Versus Conventional Medical Management Alone in the Treatment of Lumbar Spinal Stenosis.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Lead sponsor: Vertos Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 155
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in Oswestry Disability Index (ODI)
timeFrame: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Heache & Pain
state: California
city: Colorado Springs
country: United States
facility: Centura Spine Center
state: Colorado
city: Lakeland
country: United States
facility: Spine & Pain Institute of Florida
state: Florida
city: Ocala
country: United States
facility: SIMED
state: Florida
city: Seymour
country: United States
facility: The Pain Management and Rehabilitation Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas Pain Management
state: Kansas
city: Overland Park
country: United States
facility: Interventional Pain Management Specialists
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Brownstown
country: United States
facility: MI Interventional Pain Center
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: Hackensack
country: United States
facility: Center for Pain Management
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Ahoskie
country: United States
facility: Roanoke-Chowan Pain Management
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Westlake
country: United States
facility: UH St. John Pain Management Center
state: Ohio
city: Chalfont
country: United States
facility: Pennsylvania Pain & Spine Institute
state: Pennsylvania
city: Tyler
country: United States
facility: Precision Spin Care
state: Texas
city: Charleston
country: United States
facility: The Center for Pain Relief
state: West Virginia
Study officials:
References:
citation: Deer TR, Chafin TB, Costandi SJ, Qu H, Kim C, Jassal N, Patel K, Calodney A. The MOTION study: Two-year results of a real-world randomized controlled trial of the mild(R) procedure for treatment of lumbar spinal stenosis. Pain Pract. 2024 Jan;24(1):109-119. doi: 10.1111/papr.13293. Epub 2023 Sep 3.
citation: Deer TR, Costandi SJ, Washabaugh E, Chafin TB, Wahezi SE, Jassal N, Sayed D. The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild(R) Procedure: One-Year Results. Pain Med. 2022 Apr 8;23(4):625-634. doi: 10.1093/pm/pnac028.