A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain

Exclusion Criteria

• •1. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
• •1. has the mental or psychological condition that affects pain perception or
• •2. has difficulty performing objective pain assessment or lack of suitability for participation in the study.
• •2. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
• •3. Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT \< 100,000/μl or INR \> 1.4 at screening visit.
• •4. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
• •5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
• •6. Subject has a current diagnosis of cancer with active symptoms.
• •7. Subject has a known terminal illness with life expectancy less than one year.
• •8. Subject has a systematic or local infection, which may increase study risk.
• •9. Subject currently has an indwelling device that may pose an increased risk of infection.
• •10. Subject is pregnant or breast feeding.
• •11. Subject has a medical history of drug or alcohol addiction within the past 2 years.
• •12. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
• •13. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
• •14. Subject is a prisoner.