Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationNCT03610737
The MOTION Study - Treatment of LSS With the MILD Procedure
A study testing MILD Procedure and Conventional Medical Management (CMM) in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Vertos Medical, Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
- What is being tested?
- MILD Procedure and Conventional Medical Management (CMM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 18 sitesUnited States
- Study dates
- 2 Aug 2018to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Roanoke-Chowan Pain Management
Ahoskie, North Carolina, 27910
MI Interventional Pain Center
Brownstown, Michigan, 48183
Pennsylvania Pain & Spine Institute
Chalfont, Pennsylvania, 18914
The Center for Pain Relief
Charleston, West Virginia, 25301
Cleveland Clinic
Cleveland, Ohio, 44195
Centura Spine Center
Colorado Springs, Colorado, 80923
Center for Pain Management
Hackensack, New Jersey, 07601
Spine & Pain Institute of Florida
Lakeland, Florida, 33602
University of Kentucky
Lexington, Kentucky, 40508
Newport Heache & Pain
Newport Beach, California, 92660
SIMED
Ocala, Florida, 34474
Kansas Pain Management
Overland Park, Kansas, 66201
Interventional Pain Management Specialists
Overland Park, Kansas, 66209
The Pain Management and Rehabilitation Center
Seymour, Indiana, 47274
Montefiore Medical Center
The Bronx, New York, 10467
Precision Spin Care
Tyler, Texas, 75701
UH St. John Pain Management Center
Westlake, Ohio, 44145
Michigan Pain Specialists
Ypsilanti, Michigan, 63376
About this study
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.
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.
Read the 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.
- Being tested
- MILD Procedure, Conventional Medical Management (CMM)
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILD ProcedureDevice
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)Other
CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
| Study group | Role | What they receive |
|---|---|---|
| MILD with CMM | Active comparator | The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment Receives: Device: MILD Procedure; Other: Conventional Medical Management (CMM) |
| CMM alone | Active comparator | Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections. Receives: Other: Conventional Medical Management (CMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start2 Aug 2018
- Primary completion30 May 2021
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertos Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610737
- Sponsor's protocol ID
- Motion
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2018
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37661347Deer 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.
PubMed 35167700
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03610737
- Acronym / sponsor ID
- Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Vertos Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MILD with CMM | Active comparator | Device: MILD Procedure, Other: Conventional Medical Management (CMM)The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment |
| CMM alone | Active comparator | Other: Conventional Medical Management (CMM)Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILD ProcedureThe 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 | Device | MILD with CMM |
| Conventional Medical Management (CMM)CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections. | Other | CMM alone, MILD with CMM |
Primary outcome
Mean Change in Oswestry Disability Index (ODI)
Time frame: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37661347Deer 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.
- Derived from this study: PubMed 35167700Deer 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.
- The MOTION study: Two-year results of a real-world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILD Procedure and Conventional Medical Management (CMM) in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Vertos Medical, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Oswestry Disability Index (ODI) (time frame: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.