The MOTION Study - Treatment of LSS With the MILD Procedure (NCT03610737) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The MOTION Study - Treatment of LSS With the MILD Procedure
United States155 participantsStarted 2018-08-02
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Oswestry Disability Index (ODI)
Timeframe: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month