Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

Inclusion Criteria

• Age ≧20 and ≦75
• Have a symptom of back or lower limb pain with a diagnosis related to spinal lesion, herniated disc, nerve injury, stenosis, failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS) or ischemic lower limb pain and have pain history of >6 months.
• Have an average pain score >5 by Visual Analogue Scale (VAS) on inclusion.
• Has failed to achieve adequate pain relief from prior pharmacologic treatments.
• In the judgement of the investigator, the subject is an appropriate candidate for the trial procedure.
• The subject is willing and able to comply with the procedure and requirements of this trial.
• The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with Institutional Review Board (IRB) requirements.

Exclusion Criteria

• Have evidence of a mental or psychological condition that affects pain perception and has difficulty/disability performing objective pain assessment, or have previously failed mental or psychological assessments administered by a psychiatrist that may be deemed to indicate the subject's lack of suitability for participation in this study.
• Subject has exhibited unstable pain condition within the past 30 days as interviewed by Investigator.
• Be on anticoagulant medication with International Normalized Ratio (INR) >1.5 or platelet count less than 100,000/μL, peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus (DM).
• Has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
• Pain medication(s) dosages(s) are not stable for at least 30 days at investigator's discretion.
• Currently has an active implantable device including International Classification of Diseases (ICD), pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
• Have a current diagnosis of cancer with active symptoms.
• Have a known terminal illness with life expectancy less than one year.
• Have a systematic or local infection, which may increase study risk.
• Currently has an indwelling device that may pose an increased risk of infection.
• Be pregnant or breast feeding.
• Have a medical history of drug or alcohol addiction within the past 2 years.
• Participation in any investigational study in the last 30 days or current enrollment in any trial.
• Be currently involved in an injury claim law suit or medically related litigation, including workers compensation.
• Be a prisoner.