The MOTION Study - Treatment of LSS With the MILD Procedure

NCT ID: NCT03610737

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2025-04-30

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.

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MILD with CMM

The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment

Group Type: ACTIVE_COMPARATOR

MILD Procedure

Intervention Type: DEVICE

The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.

Other Name: MILD lumbar decompression

Conventional Medical Management (CMM)

Intervention Type: OTHER

CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

CMM alone

Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Group Type: ACTIVE_COMPARATOR

Conventional Medical Management (CMM)

Intervention Type: OTHER

CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Interventions

MILD Procedure

The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.

Other Name: MILD lumbar decompression

Intervention Type: DEVICE

Conventional Medical Management (CMM)

CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 37661347 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35167700 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Motion

Identifier Type: -

Identifier Source: org_study_id