Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

Exclusion Criteria

• •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.