Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
Completed · Not applicable · Has a placebo group
Conditions studied: Lumbar Spine Stenosis Central Canal
In brief
This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.
Key facts
- Study ID
- NCT01129921
- Run by
- Napa Pain Institute
- People needed
- 40
- Starts
- 2010-04-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2013-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
- Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
- Central canal cross sectional area clearly reduced per MRI/CT report.
- If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
- Able to walk at least 10 feet unaided before being limited by pain.
- Available to complete 26 weeks of follow-up.
- A signed Informed consent Form is obtained from the subject.
- Adults at least 18 years of age.
You may not qualify if…
- Prior surgery at intended treatment level.
- History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
- Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
- Disk protrusion or osteophyte formation severe enough to confound study outcome.
- Facet hypertrophy severe enough to confound study outcome.
- Bleeding disorders and/or current use of anti-coagulants.
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory (NSAID) within five days of treatment.
- Epidural steroid administration within prior 3 weeks(of procedure or sham)
- Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
- Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
- Dementia and/or inability to give informed consent.
- Pregnancy and/or breastfeeding.
- On Workman's Compensation or considering litigation associated with back pain.
Where it is running
- Napa Pain Institute — Napa, California, United States
Full record on ClinicalTrials.gov
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