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

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 a history of alcohol abuse or illicit drug use within 2 years of screening

5. Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening

6. Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.

7. Subjects who plan to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening

8. Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:

9. Subjects that have a mean of the reported 12 hour "average" NPRS responses of \< 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history

10. Subjects with a negative urine test for opioids at Baseline

11. Subjects with a positive Pregnancy test, if applicable

12. Subjects that failed the intrathecal trial during Screening

What this study is about