Clinical trial NCT03082261: Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Official title: Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Intractable Pain
Keywords: Proclaim Elite 5
Proclaim Elite 7
Prodigy
Prodigy MRI
BurstDR Stimulation
Tonic Stimulation
Multiprogram trial stimulator
Invisible trial system
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Post market, international, multicenter, interventional, prospective, single-arm study.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to 6 Months
Secondary outcomes:
measure: Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
timeFrame: Baseline to 6 Months
measure: Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 6 Months
measure: Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline to 6 Months
measure: Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
timeFrame: Baseline to 6 Months
measure: Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline to 6 Months
measure: Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
timeFrame: Baseline to 6 Months
measure: 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
timeFrame: Baseline to 6 Months
Other outcomes:
measure: Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
timeFrame: Baseline to 12 Months
measure: Mean Change in Quality of Life From Baseline to 18 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
timeFrame: Baseline to 18 Months
measure: Mean Change in Quality of Life From Baseline to 24 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
timeFrame: Baseline to 24 Months
measure: Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 3 Months
measure: Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 12 Months
measure: Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 18 Months
measure: Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 24 Months
measure: Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline to 12 Months
measure: Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline to 18 Months
measure: Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline to 24 Months
measure: Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
timeFrame: Baseline to 12 Months
measure: Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
timeFrame: Baseline to 18 Months
measure: Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
timeFrame: Baseline to 24 Months
measure: Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline to 3 Months
measure: Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline to 12 Months
measure: Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline to 18 Months
measure: Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline to 24 Months
measure: Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
timeFrame: Baseline to 12 Months
measure: Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
timeFrame: Baseline to 18 Months
measure: Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
timeFrame: Baseline to 24 Months
measure: Mean Change in Physical Function From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
timeFrame: Baseline to 12 Months
measure: Mean Change in Physical Function From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
timeFrame: Baseline to 18 Months
measure: Mean Change in Physical Function From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
timeFrame: Baseline to 24 Months
measure: Mean Change in Pain From Baseline to End of Trial System (Post-permanent Implant), Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
measure: Mean Change in Pain From Baseline to 3 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to 3 Months
measure: Mean Change in Pain From Baseline to 12 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to 12 Months
measure: Mean Change in Pain From Baseline to 18 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to 18 Months
measure: Mean Change in Pain From Baseline to 24 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline to 24 Months
measure: Number of Participants With Patient Satisfaction at End of Trial System Evaluation
timeFrame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
measure: Number of Participants With Patient Satisfaction at 3 Months
timeFrame: 3 Months
measure: Number of Participants With Patient Satisfaction at 6 Months
timeFrame: 6 Months
measure: Number of Participants With Patient Satisfaction at 12 Months
timeFrame: 12 Months
measure: Number of Participants With Patient Satisfaction at 18 Months
timeFrame: 18 Months
measure: Number of Participants With Patient Satisfaction at 24 Months
timeFrame: 24 Months
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation
timeFrame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months
timeFrame: 3 Months
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months
timeFrame: 6 Months
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months
timeFrame: 12 Months
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months
timeFrame: 18 Months
measure: Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months
timeFrame: 24 Months
measure: Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
timeFrame: 3 Months
measure: Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
timeFrame: 6 Months
measure: Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
timeFrame: 12 Months
measure: Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
timeFrame: 18 Months
measure: Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
timeFrame: 24 Months
measure: Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
timeFrame: 3 months
measure: Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
timeFrame: 6 Months
measure: Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
timeFrame: 12 Months
measure: Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
timeFrame: 18 Months
measure: Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
timeFrame: 24 Months
measure: Number of Patient Waveform Preference
timeFrame: 3 months
measure: Number of Patient Waveform Preference
timeFrame: 6 months
measure: Number of Patient Waveform Preference
timeFrame: 12 months
measure: Number of Patient Waveform Preference
timeFrame: 18 months
measure: Number of Patient Waveform Preference
timeFrame: 24 months
measure: Recharging Activities- Number of Participants With Frequency of Recharge
timeFrame: 3 months
measure: Recharging Activities- Number of Participants With Frequency of Recharge
timeFrame: 6 months
measure: Recharging Activities- Number of Participants With Frequency of Recharge
timeFrame: 12 months
measure: Recharging Activities- Number of Participants With Frequency of Recharge
timeFrame: 18 months
measure: Recharging Activities- Number of Participants With Frequency of Recharge
timeFrame: 24 months
measure: Recharging Activities- Number of Participants With Duration of Recharge
timeFrame: 3 months
measure: Recharging Activities- Number of Participants With Duration of Recharge
timeFrame: 6 months
measure: Recharging Activities- Number of Participants With Duration of Recharge
timeFrame: 12 months
measure: Recharging Activities- Number of Participants With Duration of Recharge
timeFrame: 18 months
measure: Recharging Activities- Number of Participants With Duration of Recharge
timeFrame: 24 months
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
city: Scottsdale
country: United States
facility: Tory McJunkin MD
state: Arizona
city: Tucson
country: United States
facility: Pain Institute of Southern Arizona
state: Arizona
city: Chicago
country: United States
facility: Chicago Anesthesia Associates, S.C.
state: Illinois
city: Eugene
country: United States
facility: Pacific Sports & Spine
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital & Health Network
state: Pennsylvania
city: Pottstown
country: United States
facility: Performance Spine and Sports Physicians, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Carolinas Center for Advanced Management of Pain
state: South Carolina
city: Tyler
country: United States
facility: Azalea Orthopedics
state: Texas
city: Greenfield
country: United States
facility: Advanced Pain Management
state: Wisconsin
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: CHA L'Enfant Jesus
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Eastern Finland
city: Neuss
country: Germany
facility: Neurochirurgische Praxis Neuss
state: North Rhine-Westphalia
city: Milano
country: Italy
facility: Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
state: Lombardy
city: Pisa
country: Italy
facility: Azienda Ospedaliero Univsitaria Pisana
state: Tuscany
city: Sevilla
country: Spain
facility: Hospital Virgin de Rocio
state: Andalusia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
state: Aragon
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Morges
country: Switzerland
facility: Ensemble Hospitalier de la Cote, Hopital de Morges
Study officials:
affiliation: Abbott
name: Marie Fahey
role: STUDY_DIRECTOR
References:
citation: 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.