Study of PM Modulation Therapy in Trial Phase

Inclusion criteria

• Capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
• Chronic intractable pain of the lower back equal to or greater than pain in lower limbs, and that has been refractory to conservative therapy for ≥ 3 months.
• Must be older than 18 years old.
• Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale (NPRS).
• Appropriate candidate for spinal cord stimulation trial.
• Subjects must be on a stable dose of pain medication regimen for at least 1 month.
• Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test and must be using reliable contraception and must continue to use reliable contraception until study completion. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start. Patients who become pregnant or who have a spouse/significant other that becomes pregnant during the course of this study agree to report pregnancy to the study physician/staff.
• Must be able to comply with the requirement of study visits and follow-up and phone visits.
• Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

Exclusion criteria

• Systemic infection.
• Any active implanted device.
• Previous experience with SCS therapy either during a trial or fully implanted
• Evidence of serious neurological, psychological or psychiatric disorders.
• Mechanical spinal instability.
• Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
• Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
• Human immunodeficiency virus (HIV) infection or a clinically significant infection.
• Patients who are undergoing or will undergo therapies or diagnostics that involve electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy, psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve stimulation.
• A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
• Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
• Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
• Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
• Medical condition or pain in other body areas that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
• Concurrent participation in another clinical study.
• Involvement in an injury claim under current litigation or a pending or approved workers' compensation claim.