Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

Inclusion Criteria: 1. Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed 2. Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator 3. Subject must be male or female and at least 22 years of age 4. Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening 5. Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening 6. Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history; 7. Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc. 8. Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy) 9. Subjects have not been implanted with a spinal cord stimulator for pain 10. Subjects currently do not have an implanted spinal cord stimulator for pain 11. Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history 12. Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System 13. Subject must have completed a psychological evaluation within 6 months prior to Screening 14. Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening Exclusion Criteria: A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study: 1. Subjects currently have a spinal cord stimulator implanted for pain 2. Subjects previously had a spinal cord stimulator implanted for pain 3. Subjects who have psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion 4. Subjects who have…