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

Inclusion criteria

• Age ≥ 20
• Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
• Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
• Subject is willing and able to comply with the procedure and requirements of this trial.
• The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion criteria

• Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:

• has the mental or psychological condition that affects pain perception or
• has difficulty performing objective pain assessment or lack of suitability for participation in the study.
• Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
• 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.
• Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
• 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.
• Subject has a current diagnosis of cancer with active symptoms.
• Subject has a known terminal illness with life expectancy less than one year.
• Subject has a systematic or local infection, which may increase study risk.
• Subject currently has an indwelling device that may pose an increased risk of infection.
• Subject is pregnant or breast feeding.
• Subject has a medical history of drug or alcohol addiction within the past 2 years.
• Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
• Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
• Subject is a prisoner.