Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator

Completed · Not applicable

Conditions studied: Chronic Pain, Intractable Pain

In brief

The TRIUMPH study is a post-market, international, multicenter, interventional, prospective, single-arm study intended to evaluate the sustainability of pain control and psychosocial and functional responses utilizing a multiple-waveform enabled neurostimulator in subjects with chronic, intractable pain of the trunk and/or limbs.

Key facts

Study ID: NCT03082261
Run by: Abbott Medical Devices
People needed: 269
Starts: 2017-03-03
Expected to finish: 2020-08-26
Last updated by the study team: 2021-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Subject has a score of 6 or higher on the numeric rating scale (NRS) for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
Subject is 18 years of age or older at the time of enrollment.
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.

You may not qualify if…

Subject currently has a spinal cord stimulation system implanted.
Subject has previously failed spinal cord stimulation (SCS) therapy (either trial system evaluation or permanent implant).
Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
Subject is currently participating in another clinical investigation with an active treatment arm.
Subject unable to read and/or write.

Where it is running

The CORE Institute — Phoenix, Arizona, United States
Tory McJunkin MD — Scottsdale, Arizona, United States
Pain Institute of Southern Arizona — Tucson, Arizona, United States
Chicago Anesthesia Associates, S.C. — Chicago, Illinois, United States
Pacific Sports & Spine — Eugene, Oregon, United States
St. Luke's Hospital & Health Network — Bethlehem, Pennsylvania, United States
Performance Spine and Sports Physicians, P.C. — Pottstown, Pennsylvania, United States
Clinical Trials of South Carolina — Charleston, South Carolina, United States
Carolinas Center for Advanced Management of Pain — Greenville, South Carolina, United States
Azalea Orthopedics — Tyler, Texas, United States
Advanced Pain Management — Greenfield, Wisconsin, United States
Royal University Hospital — Saskatoon, Saskatchewan, Canada
CHA L'Enfant Jesus — Québec, Canada
Kuopio University Hospital — Kuopio, Eastern Finland, Finland
Neurochirurgische Praxis Neuss — Neuss, North Rhine-Westphalia, Germany
Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta — Milan, Lombardy, Italy
Azienda Ospedaliero Univsitaria Pisana — Pisa, Tuscany, Italy
Hospital Virgin de Rocio — Seville, Andalusia, Spain
Hospital Clinico Universitario Lozano Blesa — Zaragoza, Aragon, Spain
Hospital Universitario Puerta de Hierro — Majadahonda, Spain
Hospital Universitari i Politecnic La Fe — Valencia, Spain
Ensemble Hospitalier de la Cote, Hopital de Morges — Morges, Switzerland

Full record on ClinicalTrials.gov

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