The MOTION Study - Treatment of LSS With the MILD Procedure

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
• Intervention / Treatment: Device: MILD Procedure; Other: Conventional Medical Management (CMM)

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Newport Heache & Pain
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Centura Spine Center
  • Florida
    • Lakeland, Florida, United States, 33602
      • Spine & Pain Institute of Florida
    • Ocala, Florida, United States, 34474
      • SIMED
  • Indiana
    • Seymour, Indiana, United States, 47274
      • The Pain Management and Rehabilitation Center
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Interventional Pain Management Specialists
    • Overland Park, Kansas, United States, 66201
      • Kansas Pain Management
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky
  • Michigan
    • Brownstown, Michigan, United States, 48183
      • MI Interventional Pain Center
    • Ypsilanti, Michigan, United States, 63376
      • Michigan Pain Specialists
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Center for Pain Management
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Ahoskie, North Carolina, United States, 27910
      • Roanoke-Chowan Pain Management
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Westlake, Ohio, United States, 44145
      • UH St. John Pain Management Center
  • Pennsylvania
    • Chalfont, Pennsylvania, United States, 18914
      • Pennsylvania Pain & Spine Institute
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spin Care
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Center for Pain Relief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MILD with CMM; The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment	Device: 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; Other: Conventional Medical Management (CMM); CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Active Comparator: 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.	Other: Conventional Medical Management (CMM); CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Oswestry Disability Index (ODI)	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).	Mean Change in Oswestry Disability Index (ODI) baseline to 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Numeric Pain Rating Scale (NPRS)	NPRS measures pain intensity on scale of 0 to 10. Zero (0) represents 'no pain' and '10' represents the "worst pain imaginable".	12 Month
Mean Change in Zurich Claudication Questionaire (ZCQ)	ZCQ quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. Symptom severity scale (1-5), Physical function scale (1-4), Patient's satisfaction (1-4). The lower the score the better.	12month
Walking Tolerance Test	Subjects will walk at their own desired pace, and time to symptoms will be recorded.	12 month

Collaborators and Investigators

• Sponsor: Vertos Medical, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): May 30, 2021
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Motion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No