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The MOTION Study - Treatment of LSS With the MILD Procedure

Primary Purpose

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MILD Procedure
Conventional Medical Management (CMM)
Sponsored by
Vertos Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Newport Heache & Pain
  • Centura Spine Center
  • Spine & Pain Institute of Florida
  • SIMED
  • The Pain Management and Rehabilitation Center
  • Kansas Pain Management
  • Interventional Pain Management Specialists
  • University of Kentucky
  • MI Interventional Pain Center
  • Michigan Pain Specialists
  • Center for Pain Management
  • Montefiore Medical Center
  • Roanoke-Chowan Pain Management
  • Cleveland Clinic
  • UH St. John Pain Management Center
  • Pennsylvania Pain & Spine Institute
  • Precision Spin Care
  • The Center for Pain Relief

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MILD with CMM

CMM alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 28, 2018
Last Updated
April 26, 2023
Sponsor
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03610737
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertos Medical, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MILD with CMM
Arm Type
Active Comparator
Arm Description
The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
Arm Title
CMM alone
Arm Type
Active Comparator
Arm Description
Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Intervention Type
Device
Intervention Name(s)
MILD Procedure
Intervention Description
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
Other
Intervention Name(s)
Conventional Medical Management (CMM)
Intervention Description
CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Primary Outcome Measure Information:
Title
Mean Change in Oswestry Disability Index (ODI)
Description
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).
Time Frame
Mean Change in Oswestry Disability Index (ODI) baseline to 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Newport Heache & Pain
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Centura Spine Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Spine & Pain Institute of Florida
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
SIMED
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
The Pain Management and Rehabilitation Center
City
Seymour
State/Province
Indiana
ZIP/Postal Code
47274
Country
United States
Facility Name
Kansas Pain Management
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66201
Country
United States
Facility Name
Interventional Pain Management Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Facility Name
MI Interventional Pain Center
City
Brownstown
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Michigan Pain Specialists
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
63376
Country
United States
Facility Name
Center for Pain Management
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roanoke-Chowan Pain Management
City
Ahoskie
State/Province
North Carolina
ZIP/Postal Code
27910
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UH St. John Pain Management Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Pennsylvania Pain & Spine Institute
City
Chalfont
State/Province
Pennsylvania
ZIP/Postal Code
18914
Country
United States
Facility Name
Precision Spin Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
The Center for Pain Relief
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35167700
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.
Results Reference
derived

Learn more about this trial

The MOTION Study - Treatment of LSS With the MILD Procedure

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