BurstDR Stimulation for Painful Diabetic Neuropathy

Exclusion Criteria

• •Current daily opioid dosage greater than 120 mg morphine equivalents
• •Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment
• •Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
• •Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury, as determined by the Investigator
• •Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator
• •Be benefitting from an interventional procedure and/or surgery to treat lower limb pain (Subjects should be enrolled at least 30 days from last benefit).
• •Have an existing intrathecal pain pump and/or another active implantable device such as a pacemaker
• •Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual
• •Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
• •Have a life expectancy of less than one year
• •Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs
• •Be concomitantly participating in another clinical study
• •Be involved in an injury claim under current litigation
• •Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
• •Have a pending or approved worker's compensation claim
• •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by a psychologist in the last 12 months