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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Intractable Pain
• Intervention / Treatment: Device: Prodigy, Prodigy MRI or Proclaim Elite IPG

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

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1J 1Z4
    • CHA L'Enfant Jesus
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Finland
  • Eastern Finland
    • Kuopio, Eastern Finland, Finland, 70211
      • Kuopio University Hospital
• Germany
  • North Rhine-Westphalia
    • Neuss, North Rhine-Westphalia, Germany, 41460
      • Neurochirurgische Praxis Neuss
• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20133
      • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Azienda Ospedaliero Univsitaria Pisana
• Spain
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Andalusia
    • Sevilla, Andalusia, Spain, 41013
      • Hospital Virgin de Rocio
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Clínico Universitario Lozano Blesa
• Switzerland
  • Morges, Switzerland, 1110
    • Ensemble Hospitalier de la Cote, Hopital de Morges
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85351
      • The Core Institute
    • Scottsdale, Arizona, United States, 85255
      • Tory McJunkin MD
    • Tucson, Arizona, United States, 85712
      • Pain Institute of Southern Arizona
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Associates, S.C.
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Sports & Spine
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18951
      • St. Luke's Hospital & Health Network
    • Pottstown, Pennsylvania, United States, 19403
      • Performance Spine and Sports Physicians, P.C.
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Greenville, South Carolina, United States, 29316
      • Carolinas Center for Advanced Management of Pain
  • Texas
    • Tyler, Texas, United States, 75701
      • Azalea Orthopedics
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53221
      • Advanced Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Device: Prodigy, Prodigy MRI or Proclaim Elite IPG; Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire	EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.	Baseline to 6 Months
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.	Baseline to 6 Months
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.	Baseline to 6 Months
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).	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)	The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.	Baseline to 6 Months
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.	Baseline to 6 Months
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	The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.	Baseline to 6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire	EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.	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	EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.	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	EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.	Baseline to 24 Months
Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.	Baseline to 3 Months
Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.	Baseline to 12 Months
Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.	Baseline to 18 Months
Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.	Baseline to 24 Months
Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.	Baseline to 12 Months
Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.	Baseline to 18 Months
Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.	Baseline to 24 Months
Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).	Baseline to 12 Months
Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).	Baseline to 18 Months
Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).	Baseline to 24 Months
Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.	Baseline to 3 Months
Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.	Baseline to 12 Months
Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.	Baseline to 18 Months
Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.	Baseline to 24 Months
Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.	Baseline to 12 Months
Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.	Baseline to 18 Months
Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.	Baseline to 24 Months
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	The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.	Baseline to 12 Months
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	The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.	Baseline to 18 Months
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	The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.	Baseline to 24 Months
Mean Change in Pain From Baseline to End of Trial System (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 end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Mean Change in Pain From Baseline to 3 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 3 Months
Mean Change in Pain From Baseline to 12 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 12 Months
Mean Change in Pain From Baseline to 18 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 18 Months
Mean Change in Pain From Baseline to 24 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 24 Months
Number of Participants With Patient Satisfaction at End of Trial System Evaluation	Patient satisfaction will be summarized by count and percentage of participants	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Number of Participants With Patient Satisfaction at 3 Months	Patient satisfaction will be summarized by count and percentage of participants	3 Months
Number of Participants With Patient Satisfaction at 6 Months	Patient satisfaction will be summarized by count and percentage of participants	6 Months
Number of Participants With Patient Satisfaction at 12 Months	Patient satisfaction will be summarized by count and percentage of participants	12 Months
Number of Participants With Patient Satisfaction at 18 Months	Patient satisfaction will be summarized by count and percentage of participants	18 Months
Number of Participants With Patient Satisfaction at 24 Months	Patient satisfaction will be summarized by count and percentage of participants	24 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	3 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	6 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	12 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	18 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months	The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.	24 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	Medication usage measured as decrease in chronic pain related medication intake since baseline	3 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	Medication usage measured as decrease in chronic pain related medication intake since baseline	6 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	Medication usage measured as decrease in chronic pain related medication intake since baseline	12 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	Medication usage measured as decrease in chronic pain related medication intake since baseline	18 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	Medication usage measured as decrease in chronic pain related medication intake since baseline	24 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.	3 months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.	6 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.	12 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.	18 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.	24 Months
Number of Patient Waveform Preference	Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.	3 months
Number of Patient Waveform Preference	Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.	6 months
Number of Patient Waveform Preference	Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.	12 months
Number of Patient Waveform Preference	Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.	18 months
Number of Patient Waveform Preference	Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.	24 months
Recharging Activities- Number of Participants With Frequency of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	3 months
Recharging Activities- Number of Participants With Frequency of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	6 months
Recharging Activities- Number of Participants With Frequency of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	12 months
Recharging Activities- Number of Participants With Frequency of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants	18 months
Recharging Activities- Number of Participants With Frequency of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	24 months
Recharging Activities- Number of Participants With Duration of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	3 months
Recharging Activities- Number of Participants With Duration of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	6 months
Recharging Activities- Number of Participants With Duration of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	12 months
Recharging Activities- Number of Participants With Duration of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	18 months
Recharging Activities- Number of Participants With Duration of Recharge	Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.	24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Marie Fahey, Abbott

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Prodigy; Proclaim Elite 5; Proclaim Elite 7; Prodigy MRI; BurstDR Stimulation; Tonic Stimulation; Multiprogram trial stimulator; Invisible trial system
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pain, Intractable
• Other Study ID Numbers: SJM-CIP-10145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes