N/A
Completed N=269
Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Postoperative Pain · Intractable Pain
Source: ClinicalTrials.gov NCT03082261 ↗
Enrolled (actual)
269
Serious AEs
6.7%
Results posted
Jun 2021
Primary outcomePrimary: Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) — 7.6; 4.6; 3.0 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) |
7.6; 4.6; 3.0 | — |
| SECONDARY Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire |
0.44; 0.65; 0.21 | — |
| SECONDARY Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS) |
25.6; 13.7; 11.9 | — |
| SECONDARY Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI) |
87.1; 77.1; 10.0 | — |
| SECONDARY Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9) |
10.5; 7.6; 3.0 | — |
| SECONDARY Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK) |
28.7; 24.9; 3.8 | — |
| SECONDARY Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale |
52.6; 45.0; 7.5 | — |
| SECONDARY Mean Change in Physical Function From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale |
32.9; 36.7; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03082261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.