The MiDAS ENCORE Study
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003187
NCT ID: NCT02093520
Sponsor Protocol Number: MiDAS ENCORE
About this study
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 65 years or older and a Medicare beneficiary.
- Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
- LSS with neurogenic claudication diagnosed via:
- Symptomatic diagnosis and
- 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, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
- Available to complete 6 month and one year follow-up visits.
Exclusion Criteria:
- ODI Score < 31 (0-100 ODI Scale).
- NPRS Score < 5 (0-10 NPRS Scale).
- Prior surgery at any treatment level.
- History of recent spinal fractures with current related pain symptoms.
- Patients with Grade III 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.
- Patients previously randomized and/or treated in this clinical study.
- Patients that have previously received the MILD procedure.
- ESI during eight weeks prior to study enrollment.
- 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 the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Tim Lamer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available