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

NCT ID: NCT03082261

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2020-08-26

Brief Summary

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.

Detailed Description

TRIUMPH study will utilize the multiprogram trial stimulator or invisible trial system with BurstDR for the trial evaluation period and the Prodigy or Proclaim Elite family of neurostimulators with tonic or BurstDR waveform at permanent implant and follow-up for pain control and improvement of psychosocial function. The follow-up visits will be scheduled at 3, 6, 12, 18, and 24 months post permanent implant

Conditions

Chronic Pain; Intractable Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All enrolled subjects

All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG).

Group Type: OTHER

Prodigy, Prodigy MRI or Proclaim Elite IPG

Intervention Type: DEVICE

Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG

Interventions

Prodigy, Prodigy MRI or Proclaim Elite IPG

Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.

4. Subject is 18 years of age or older at the time of enrollment.

5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.

6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.

Exclusion Criteria

1. Subject currently has a spinal cord stimulation system implanted.

2. Subject has previously failed spinal cord stimulation (SCS) therapy (either trial system evaluation or permanent implant).

3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.

4. 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.

5. Subject is currently participating in another clinical investigation with an active treatment arm.

6. Subject unable to read and/or write.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Fahey

Role: STUDY_DIRECTOR

Abbott

Locations

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

Countries

United States; Canada; Finland; Germany; Italy; Spain; Switzerland

References

Deer TR, Falowski SM, Moore GA, Hutcheson JK, Pena I, Candido K, Cornidez EG, Fraunberg VUZ, Blomme B, Capobianco RA. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study. Spine (Phila Pa 1976). 2022 Apr 1;47(7):548-556. doi: 10.1097/BRS.0000000000004283.

Reference Type: DERIVED

PMID: 34812195 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10145

Identifier Type: -

Identifier Source: org_study_id