NCT04096391

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Evolve Restorative Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Nonmalignant Pain
• Pain, Intractable
• Pain, Chronic

Interventions

Type	Name	Description
DEVICE	Flowonix Prometra® II Programmable Infusion System	The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).
DRUG	Pain Medicine	Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Timeline

• Start date: 2019-06-05
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2019-09-19
• Last updated: 2022-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study