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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03082261

Acronym

TRIUMPH

Enrollment

269

Registered

2017-03-17

Start date

2017-03-03

Completion date

2020-08-26

Last updated

2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DEVICEProdigy, Prodigy MRI or Proclaim Elite IPG

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Post market, international, multicenter, interventional, prospective, single-arm study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline to 6 Months	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.

Secondary

Measure	Time frame	Description
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline to 6 Months	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.
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Baseline to 6 Months	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.
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Baseline to 6 Months	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).
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	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.
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Baseline to 6 Months	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.
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	Baseline to 6 Months	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.
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	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.

Other

Measure	Time frame	Description
Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Baseline to 18 Months	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.
Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Baseline to 24 Months	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.
Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Baseline to 12 Months	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).
Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Baseline to 18 Months	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).
Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Baseline to 24 Months	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).
Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Baseline to 3 Months	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.
Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Baseline to 12 Months	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.
Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Baseline to 18 Months	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.
Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Baseline to 24 Months	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.
Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Baseline to 12 Months	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.
Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Baseline to 18 Months	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.
Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Baseline to 24 Months	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.
Mean Change in Pain From Baseline to 12 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline to 12 Months	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.
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	Baseline to 12 Months	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.
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	Baseline to 18 Months	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.
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	Baseline to 24 Months	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.
Mean Change in Pain From Baseline to End of Trial System (Post-permanent Implant), Assessed by the Numeric Rating Scale (NRS)	Baseline to end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation	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.
Mean Change in Pain From Baseline to 3 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline to 3 Months	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.
Mean Change in Pain From Baseline to 18 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline to 18 Months	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.
Mean Change in Pain From Baseline to 24 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline to 24 Months	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.
Number of Participants With Patient Satisfaction at End of Trial System Evaluation	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation	Patient satisfaction will be summarized by count and percentage of participants
Number of Participants With Patient Satisfaction at 3 Months	3 Months	Patient satisfaction will be summarized by count and percentage of participants
Number of Participants With Patient Satisfaction at 6 Months	6 Months	Patient satisfaction will be summarized by count and percentage of participants
Number of Participants With Patient Satisfaction at 12 Months	12 Months	Patient satisfaction will be summarized by count and percentage of participants
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	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.
Number of Participants With Patient Satisfaction at 24 Months	24 Months	Patient satisfaction will be summarized by count and percentage of participants
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation	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.
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months	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.
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months	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.
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months	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.
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months	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.
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months	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.
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline	3 Months	Medication usage measured as decrease in chronic pain related medication intake since baseline
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form	3 months	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Number of Patient Waveform Preference	3 months	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.
Recharging Activities- Number of Participants With Frequency of Recharge	3 months	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.
Recharging Activities- Number of Participants With Duration of Recharge	3 months	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.
Number of Participants With Patient Satisfaction at 18 Months	18 Months	Patient satisfaction will be summarized by count and percentage of participants
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	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.
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	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.
Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline to 3 Months	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.
Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline to 12 Months	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.
Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline to 18 Months	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.
Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline to 24 Months	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.
Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Baseline to 12 Months	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.

Countries

Canada, Finland, Germany, Italy, Spain, Switzerland, United States

Participant flow

Recruitment details

A total of 269 subjects were enrolled at 22 investigational sites. The enrollment of the first subject was on 03 March 2017 and the last subject was on 13 February 2018. The last follow-up visit occurred on 26 August 2020.

Participants by arm

Arm	Count
All Enrolled Subjects All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG	269
Total	269

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	4
Overall Study	Implant of dorsal root ganglion stimulation (DRG) device	1
Overall Study	Insurance denial	1
Overall Study	Lost to Follow-up	14
Overall Study	Peripheral lead added	1
Overall Study	Subject did not meet screening inclusion/exclusion criteria	2
Overall Study	Subject implanted with device other than study device	1
Overall Study	Subject moved to a different state	1
Overall Study	Subject non-compliance	2
Overall Study	Subject participation terminated by investigator	9
Overall Study	Subject participation terminated by sponsor	4
Overall Study	System explant	19
Overall Study	Unable to place lead(s)	2
Overall Study	Unsuccessful trial evaluation period	19
Overall Study	Withdrawal by Subject	40

Baseline characteristics

Characteristic	All Enrolled Subjects	—
Age, Continuous	59.4 years STANDARD_DEVIATION 13.6	—
Duration of Experiencing Chronic Pain	9.7 years STANDARD_DEVIATION 8.6	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	7 participants	—
Region of Enrollment Finland	12 participants	—
Region of Enrollment Germany	5 participants	—
Region of Enrollment Italy	8 participants	—
Region of Enrollment Spain	26 participants	—
Region of Enrollment Switzerland	1 participants	—
Region of Enrollment United States	210 participants	—
Sex: Female, Male Female	166 Participants	—
Sex: Female, Male Male	103 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	4 / 269
other Total, other adverse events	27 / 269
serious Total, serious adverse events	18 / 269

Outcome results

Primary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Baseline	7.6 score on a scale	Standard Deviation 1.1
All Enrolled Subjects	Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	6 months	4.6 score on a scale	Standard Deviation 2.4
All Enrolled Subjects	Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)	Change from baseline to 6 months	3.0 score on a scale	Standard Deviation 2.6

Secondary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Baseline	87.1 score on a scale	Standard Deviation 26.1
All Enrolled Subjects	Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	6 months	77.1 score on a scale	Standard Deviation 24.7
All Enrolled Subjects	Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)	Change from baseline to 6 months	10.0 score on a scale	Standard Deviation 21.6

Secondary

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).

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Baseline	10.5 score on a scale	Standard Deviation 6.5
All Enrolled Subjects	Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	6 months	7.6 score on a scale	Standard Deviation 6.5
All Enrolled Subjects	Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)	Change from baseline to 6 months	3.0 score on a scale	Standard Deviation 5.5

Secondary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Baseline	28.7 score on a scale	Standard Deviation 7.8
All Enrolled Subjects	Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	6 months	24.9 score on a scale	Standard Deviation 7.2
All Enrolled Subjects	Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)	Change from baseline to 6 months	3.8 score on a scale	Standard Deviation 6.7

Secondary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Baseline	25.6 score on a scale	Standard Deviation 12.9
All Enrolled Subjects	Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	6 months	13.7 score on a scale	Standard Deviation 12.2
All Enrolled Subjects	Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)	Change from baseline to 6 months	11.9 score on a scale	Standard Deviation 11.8

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

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	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	Baseline	32.9 T-score	Standard Deviation 5
All Enrolled Subjects	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	6 months	36.7 T-score	Standard Deviation 6.8
All Enrolled Subjects	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	Change from baseline to 6 months	3.8 T-score	Standard Deviation 5.4

Secondary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire	Baseline	0.44 score on a scale	Standard Deviation 0.22
All Enrolled Subjects	Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire	6 months	0.65 score on a scale	Standard Deviation 0.21
All Enrolled Subjects	Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire	Change from baseline to 6 months	0.21 score on a scale	Standard Deviation 0.22

Secondary

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.

Time frame: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
All Enrolled Subjects	Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Baseline	52.6 score on a scale	Standard Deviation 21.8
All Enrolled Subjects	Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	6 months	45.0 score on a scale	Standard Deviation 23.2
All Enrolled Subjects	Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale	Change from baseline to 6 months	7.5 score on a scale	Standard Deviation 18.8

Other Pre-specified