A Study to Evaluate the Treatment of Lumbar Spinal Stenosis (LSS) with the MILD Procedure

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 19-003011
    Sponsor Protocol Number: MOTION

About this study

The purpose of this study is to examine 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tim Lamer, M.D.

Open for enrollment

Contact information:

Matthew Johnson R.R.T., L.R.T.

(507)255-8248

Johnson.Matthew6@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20462494

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