A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)

ABSTRACT

Introduction

Intrathecal therapy has been limited by non-randomized prospective studies, particularly for those suffering from non-cancer. Further, no prospective, randomized studies investigating the efficacy, safety, and utilization of intrathecal polyanalgesic consensus guidelines exist.

Methods

After IRB approval, patients were enrolled in a 1:1 fashion for intrathecal drug delivery (IDD) or conventional management (CMM), employing standard of care, excluding intrathecal drug delivery, based on the principal investigator’s discretion. They were followed 3, 6, 9, and 12 months. Assessments included PROMIS 29, NPRS, and PriceMonkey.

Results

Seventy-nine patients were screened, 54 patients were enrolled: 26 to IDD and 28 to CMM. At 3 months, there was no measurable difference in pain improvement in either subgroups within the CMM for chronic pain-related syndromes (CPRS) or failed back and related spine disorders (FBRS). For the IDD, early and maintained benefit from the baseline was statistically achieved. Cost analysis of pump to CMM breakeven was 4.5 months. There were no adverse events related to compounded intrathecal medications.

Conclusion

This is the first randomized prospective, multicenter study investigating the safety, cost, and efficacy of off-label medications for intrathecal therapy, as compared to conventional management, and suggests early detection of improvement, cost savings, safety of intrathecal compounded medication use, and safety and efficacy of employing the PACC guidance.

KEYWORDS:

• Intrathecal therapy
• prospective
• randomized
• polyanalgesic consensus conference

Acknowledgments

The authors would like to thank Shelley Trimm, Kamren Murrell, Eric Bruntlett, Duane Day, Benjamin John, Jonathon Hamer, and John Finley for their support of the study.

Declaration of interest

Dr. Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Painteq, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, MainStay, WISE, Boston Scientific, Thermaquil; has received grant and research support from Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, MainStay, Vertos, AIS, Thermaquil; and is a shareholder of Painteq, Vertos, SPR Therapeutics, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil and Anesthetic Gas Reclamation. Dr. Jassal has received research support from AIS, Flowonix, Boston Scientific, and Vertos. Dr. Sayed Dr. Sayed is a consultant for Abbott, MainStay, Boston Scientific, Flowonix, Medtronic, Nevro, Painteq, Saluda, SPR, Surgentec, and Vertos. Dr. Patterson serves as a consultant for Abbott, AIS, Allergan, Amgen, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Pajunk Medical, Saluda, Spark Biomedical, Vertos, has received grant and research support from Abbott, Flowonix, Nevro, Saluda and Vertiflex, and serves on the Speaker Bureau or Honoraria for Abbott, Allergan, Amgen, CornerLoc, Lundbeck, Saluda, Vertos, and has equity in CornerLoc. Dr. McDowell serves as a consultant for Nevro, Medtronic, Biotronik, Flowonix, TerSera; has received grant and research support from Nevro, Medtronic, Saluda, Biotronik, Flowonix and Tersera and serves on the Speaker’s Bureau for TerSera; and has stock options in Flowonix. Dr. Bux serves as a Consultant for Boston Scientific, Vertos, Flowonix, AIS Healthcare, Spark Biomedical, Cornerloc, Omnia, is on the Advisory Board AIS Healthcare, Vertos, and receives Grant and research support from Boston Scientific and Flowonix. Dr. Lim is a consultant for Boston Scientific, Medtronic, and Southern Spine. Dr. Chang serves as a consultant for Flowonix and Medtronic and has received grants and research support from Medtronic and Abbott. Dr. Nairizi serves as a Consultant for Nevro, Flowonix, Boston Scientific, Surgentec, Aurora Pain and Spine and has received research support from Nevro, Corner Loc, Cardio Surgical Partners and Flowonix. Dr. Deer serves as a consultant for Abbott, Medtronic, Cornorloc, Painteq, Spinal Simplicity, SPR, Saluda and has received research support from Abbott, Vertiflex (BSI), Painteq, Vertos, and Saluda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

The study was sponsored by the Pacific Research Institute and supported by Flowonix and AIS.