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

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Trial Identification

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

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

Study ID: NCT04096391

Conditions

Chronic Nonmalignant Pain

Pain, Intractable

Pain, Chronic

Interventions

Flowonix Prometra® II Programmable Infusion System

Pain Medicine

Study Description

Brief Summary: This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.

Detailed Description: This study will evaluate the following objectives: Primary objective: 1. To compare the change in pain intensity from baseline based on the Numeric Rating Scale \[NRS\] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation. Secondary objectives: For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable. 1. Compare the subject reported PROMIS 29 between the IDDS group and CMM group. Individual subject scores recorded at baseline and months 3, 6, 9 and 12. 2. Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group 3. Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group. Individual subject counts recorded at months 3, 6, 9 and 12 will be compared. Additional safety objective: 1. To characterize pain and device related adverse events for all subjects throughout the study through completion of 12 month follow-up or subject exit.