NCT03082261

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable chronic-pain

Geographic Reach
7 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 2, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

March 13, 2017

Results QC Date

March 30, 2021

Last Update Submit

July 7, 2021

Conditions

Chronic PainIntractable Pain

Keywords

Proclaim Elite 5Proclaim Elite 7ProdigyProdigy MRIBurstDR StimulationTonic StimulationMultiprogram trial stimulatorInvisible trial system

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)

    The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

    Baseline to 6 Months

Secondary Outcomes (7)

  • Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire

    Baseline to 6 Months

  • Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)

    Baseline to 6 Months

  • Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)

    Baseline to 6 Months

  • Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)

    Baseline to 6 Months

  • Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)

    Baseline to 6 Months

  • +2 more secondary outcomes

Other Outcomes (65)

  • Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire

    Baseline to 12 Months

  • Mean Change in Quality of Life From Baseline to 18 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire

    Baseline to 18 Months

  • Mean Change in Quality of Life From Baseline to 24 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire

    Baseline to 24 Months

  • +62 more other outcomes

Study Arms (1)

All enrolled subjects

OTHER

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

Device: Prodigy, Prodigy MRI or Proclaim Elite IPG

Interventions

Prodigy, Prodigy MRI or Proclaim Elite IPGDEVICE

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

All enrolled subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

The CORE Institute

Phoenix, Arizona, 85351, United States

Location

Tory McJunkin MD

Scottsdale, Arizona, 85255, United States

Location

Pain Institute of Southern Arizona

Tucson, Arizona, 85712, United States

Location

Chicago Anesthesia Associates, S.C.

Chicago, Illinois, 60657, United States

Location

Pacific Sports & Spine

Eugene, Oregon, 97401, United States

Location

St. Luke's Hospital & Health Network

Bethlehem, Pennsylvania, 18951, United States

Location

Performance Spine and Sports Physicians, P.C.

Pottstown, Pennsylvania, 19403, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Carolinas Center for Advanced Management of Pain

Greenville, South Carolina, 29316, United States

Location

Azalea Orthopedics

Tyler, Texas, 75701, United States

Location

Advanced Pain Management

Greenfield, Wisconsin, 53221, United States

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

CHA L'Enfant Jesus

Québec, G1J 1Z4, Canada

Location

Kuopio University Hospital

Kuopio, Eastern Finland, 70211, Finland

Location

Neurochirurgische Praxis Neuss

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliero Univsitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Hospital Virgin de Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Ensemble Hospitalier de la Cote, Hopital de Morges

Morges, 1110, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 34812195DERIVED

MeSH Terms

Conditions

Chronic PainPain, Intractable

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Robyn Capobianco
Organization
Abbott
robyn.capobianco@abbott.com
+15129343941

Study Officials

  • Marie Fahey

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Post market, international, multicenter, interventional, prospective, single-arm study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 17, 2017

Study Start

March 3, 2017

Primary Completion

January 24, 2019

Study Completion

August 26, 2020

Last Updated

July 8, 2021

Results First Posted

June 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(11)IT(2)FI(1)DE(1)ES(4)CH(1)CA(2)