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

Abbott

Status: Completed

Conditions: Intractable Pain; Chronic Pain

Treatments: Device: Prodigy, Prodigy MRI or Proclaim Elite IPG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03082261

SJM-CIP-10145

Details and patient eligibility

About

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.

Full 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

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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269 participants in 1 patient group

All enrolled subjects

Other group

Description:

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

Treatment:

Device: Prodigy, Prodigy MRI or Proclaim Elite IPG