High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

Inclusion Criteria:

- Chronic intractable pain of the trunk and/or limbs

- Documented history of trunk and/or limb pain of at least 180 days

- Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during
the 7-day period prior to the Screening Visit

- Pass study site's routine psychological/psychiatric evaluation within 180 days of the
Trial Lead Insertion Visit

- If taking any medications for chronic pain, must be on a stable prescription during
the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on
the same prescription throughout study participation

- Subject is willing and able to comply with all protocol-required procedures and
assessments/evaluations

- Subject is able to independently read and complete all questionnaires and/or
assessments provided in English

- 18 years of age or older when written informed consent is obtained

- Subject signs a valid, Institutional Review Board (IRB)-approved informed consent
form (ICF) provided in English

Exclusion Criteria:

- Unable to operate the Precision Plus system

- Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine

- Is a high surgical risk

- Is diabetic

- Is immunocompromised

- Currently on any anticoagulant medications that cannot be discontinued during
perioperative period

- Untreated major depression or untreated generalized anxiety disorder

- Diagnosed with somatoform disorder, severe personality disorder, borderline
personality disorder

- Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8

- Currently diagnosed with cognitive impairment that would limit subject's ability to
discern differences in pain severity, complete a pain diary, perform wound care

- Current abuse of alcohol or illicit drugs

- Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).

- Subject is participating (or intends to participate) in another drug or device
clinical trial that may influence the data that will be collected for this study

- Subject has previously undergone a spinal cord stimulation trial or is already
implanted with an active implantable device(s) to treat their pain (Implantable Pulse
Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac
defibrillator

- Patient is a woman who is not using adequate contraception, is pregnant or
breastfeeding or intends to become pregnant during the course of the study (a urine
pregnancy test must be performed within 28 days prior to the Trial Lead Insertion
Visit in women of child-bearing potential and the test result documented)