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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT03082261

Collaborator

(none)

269

Enrollment

Locations

Arm

41.8

Actual Duration (Months)

12.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Intractable Pain	Device: Prodigy, Prodigy MRI or Proclaim Elite IPG	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

269 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 3, 2017

Actual Primary Completion Date :

Jan 24, 2019

Actual Study Completion Date :

Aug 26, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 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.
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.

Other Outcome Measures

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.
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.
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 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 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 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
Number of Participants With Patient Satisfaction at 18 Months [18 Months]
Patient satisfaction will be summarized by count and percentage of participants
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
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline [6 Months]
Medication usage measured as decrease in chronic pain related medication intake since baseline
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline [12 Months]
Medication usage measured as decrease in chronic pain related medication intake since baseline
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline [18 Months]
Medication usage measured as decrease in chronic pain related medication intake since baseline
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline [24 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 Participants With Stimulation Sensation Assessed by Stimulation Assessment Form [6 Months]
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form [12 Months]
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form [18 Months]
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form [24 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.
Number of Patient Waveform Preference [6 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.
Number of Patient Waveform Preference [12 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.
Number of Patient Waveform Preference [18 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.
Number of Patient Waveform Preference [24 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 Frequency of Recharge [6 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 Frequency of Recharge [12 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 Frequency of Recharge [18 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 Frequency of Recharge [24 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.
Recharging Activities- Number of Participants With Duration of Recharge [6 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 [12 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 [18 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 [24 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Subject has a score of 6 or higher on the numeric rating scale (NRS) for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
Subject is 18 years of age or older at the time of enrollment.
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.

Exclusion Criteria:

Subject currently has a spinal cord stimulation system implanted.
Subject has previously failed spinal cord stimulation (SCS) therapy (either trial system evaluation or permanent implant).
Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
Subject is currently participating in another clinical investigation with an active treatment arm.
Subject unable to read and/or write.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Study Director: Marie Fahey, Abbott

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Nov 19, 2018

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT03082261

Other Study ID Numbers:

SJM-CIP-10145

First Posted:

Mar 17, 2017

Last Update Posted:

Jul 8, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Abbott Medical Devices

Multiprogram trial stimulator

Invisible trial system

Additional relevant MeSH terms:

Chronic Pain

Pain, Intractable

Study Results

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.
Pre-assignment Detail

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG). Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Period Title: Overall Study
STARTED	269
COMPLETED	149
NOT COMPLETED	120

Baseline Characteristics

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Overall Participants	269
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (13.6)
Sex: Female, Male (Count of Participants)
Female	166 61.7%
Male	103 38.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	7 2.6%
United States	210 78.1%
Finland	12 4.5%
Italy	8 3%
Switzerland	1 0.4%
Germany	5 1.9%
Spain	26 9.7%
Duration of Experiencing Chronic Pain (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.7 (8.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
Baseline	7.6 (1.1)
6 months	4.6 (2.4)
Change from baseline to 6 months	3.0 (2.6)

2. Secondary Outcome

Title	Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	0.44 (0.22)
6 months	0.65 (0.21)
Change from baseline to 6 months	0.21 (0.22)

3. Secondary Outcome

Title	Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	25.6 (12.9)
6 months	13.7 (12.2)
Change from baseline to 6 months	11.9 (11.8)

4. Secondary Outcome

Title	Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	87.1 (26.1)
6 months	77.1 (24.7)
Change from baseline to 6 months	10.0 (21.6)

5. Secondary Outcome

Title	Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	10.5 (6.5)
6 months	7.6 (6.5)
Change from baseline to 6 months	3.0 (5.5)

6. Secondary Outcome

Title	Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	28.7 (7.8)
6 months	24.9 (7.2)
Change from baseline to 6 months	3.8 (6.7)

7. Secondary Outcome

Title	Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	180
Baseline	52.6 (21.8)
6 months	45.0 (23.2)
Change from baseline to 6 months	7.5 (18.8)

8. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

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

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	171
Baseline	32.9 (5.0)
6 months	36.7 (6.8)
Change from baseline to 6 months	3.8 (5.4)

9. Other Pre-specified Outcome

Title	Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	0.44 (0.21)
12 months	0.63 (0.23)
Change from baseline to 12 months	0.20 (0.23)

10. Other Pre-specified Outcome

Title	Mean Change in Quality of Life From Baseline to 18 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	0.44 (0.21)
18 months	0.65 (0.20)
Change from baseline to 18 months	0.22 (0.23)

11. Other Pre-specified Outcome

Title	Mean Change in Quality of Life From Baseline to 24 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Baseline	0.44 (0.21)
24 months	0.64 (0.21)
Change from baseline to 24 months	0.21 (0.23)

12. Other Pre-specified Outcome

Title	Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Description	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 3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Baseline	25.7 (13.1)
3 months	14.6 (12.3)
Change from baseline to 3 months	10.6 (13.4)

13. Other Pre-specified Outcome

Title	Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	25.7 (13.1)
12 months	14.3 (13.1)
Change from baseline to 12 months	11.3 (12.1)

14. Other Pre-specified Outcome

Title	Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	25.7 (13.1)
18 months	14.0 (11.5)
Change from baseline to 18 months	12.4 (12.8)

15. Other Pre-specified Outcome

Title	Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Baseline	25.7 (13.1)
24 months	13.2 (12.6)
Change from baseline to 24 months	12.5 (12.8)

16. Other Pre-specified Outcome

Title	Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	87.5 (26.2)
12 months	77.3 (26.9)
Change from baseline to 12 months	9.3 (22.2)

17. Other Pre-specified Outcome

Title	Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	87.5 (26.2)
18 months	75.1 (24.9)
Change from baseline to 18 months	11.4 (21.4)

18. Other Pre-specified Outcome

Title	Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Baseline	87.5 (26.2)
24 months	75.5 (26.7)
Change from baseline to 24 months	10.8 (21.7)

19. Other Pre-specified Outcome

Title	Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	10.2 (6.5)
12 months	7.7 (6.6)
Change from baseline to 12 months	2.8 (5.6)

20. Other Pre-specified Outcome

Title	Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	10.2 (6.5)
18 months	6.9 (5.8)
Change from baseline to 18 months	3.7 (6.4)

21. Other Pre-specified Outcome

Title	Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Baseline	10.2 (6.5)
24 months	7.5 (6.4)
Change from baseline to 24 months	3.0 (6.1)

22. Other Pre-specified Outcome

Title	Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Description	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 3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	191
Baseline	28.7 (7.7)
3 months	24.6 (7.2)
Change from baseline to 3 months	3.8 (7.5)

23. Other Pre-specified Outcome

Title	Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	28.7 (7.7)
12 months	24.4 (7.2)
Change from baseline to 12 months	4.3 (7.1)

24. Other Pre-specified Outcome

Title	Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	28.7 (7.7)
18 months	24.3 (7.4)
Change from baseline to 18 months	4.8 (7.5)

25. Other Pre-specified Outcome

Title	Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	139
Baseline	28.7 (7.7)
24 months	25.2 (7.5)
Change from baseline to 24 months	4.2 (7.6)

26. Other Pre-specified Outcome

Title	Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	162
Baseline	50.3 (22.6)
12 months	45.4 (23.5)
Change from baseline to 12 months	7.6 (20.0)

27. Other Pre-specified Outcome

Title	Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	116
Baseline	50.3 (22.6)
18 months	43.8 (23.8)
Change from baseline to 18 months	9.9 (20.6)

28. Other Pre-specified Outcome

Title	Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	139
Baseline	50.3 (22.6)
24 months	43.2 (22.1)
Change from baseline to 24 months	10.8 (20.7)

29. Other Pre-specified Outcome

Title	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
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	155
Baseline	33.0 (5.2)
12 months	36.3 (6.6)
Change from baseline to 12 months	3.2 (5.4)

30. Other Pre-specified Outcome

Title	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
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	110
Baseline	33.0 (5.2)
18 months	37.1 (6.3)
Change from baseline to 18 months	3.7 (6.1)

31. Other Pre-specified Outcome

Title	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
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	134
Baseline	33.0 (5.2)
24 months	36.9 (7.6)
Change from baseline to 24 months	3.8 (6.8)

32. Other Pre-specified Outcome

Title	Mean Change in Pain From Baseline to End of Trial System (Post-permanent Implant), Assessed by the Numeric Rating Scale (NRS)
Description	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 end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	244
Baseline	7.7 (1.2)
End of trial	3.5 (2.1)
Change from baseline to end of trial	4.2 (2.3)

33. Other Pre-specified Outcome

Title	Mean Change in Pain From Baseline to 3 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Description	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 3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Baseline	7.7 (1.2)
3 months	4.4 (2.4)
Change from baseline to 3 months	3.3 (2.5)

34. Other Pre-specified Outcome

Title	Mean Change in Pain From Baseline to 12 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Description	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 12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
Baseline	7.7 (1.2)
12 months	4.7 (2.5)
Change from baseline to 12 months	2.9 (2.5)

35. Other Pre-specified Outcome

Title	Mean Change in Pain From Baseline to 18 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Description	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 18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	145
Baseline	7.7 (1.2)
18 months	4.5 (2.5)
Change from baseline to 18 months	3.1 (2.6)

36. Other Pre-specified Outcome

Title	Mean Change in Pain From Baseline to 24 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Description	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 24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Baseline	7.7 (1.2)
24 months	4.8 (2.5)
Change from baseline to 24 months	2.8 (2.6)

37. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at End of Trial System Evaluation
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	244
Very Satisfied	125 46.5%
Satisfied	94 34.9%
Neither Satisfied or Dissatisfied	7 2.6%
Dissatisfied	10 3.7%
Very Dissatisfied	8 3%

38. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at 3 Months
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Very Satisfied	72 26.8%
Satisfied	75 27.9%
Neither Satisfied or Dissatisfied	31 11.5%
Dissatisfied	14 5.2%
Very Dissatisfied	0 0%

39. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at 6 Months
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
Very Satisfied	67 24.9%
Satisfied	68 25.3%
Neither Satisfied or Dissatisfied	34 12.6%
Dissatisfied	11 4.1%
Very Dissatisfied	1 0.4%

40. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at 12 Months
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
Very Satisfied	58 21.6%
Satisfied	75 27.9%
Neither Satisfied or Dissatisfied	21 7.8%
Dissatisfied	7 2.6%
Very Dissatisfied	2 0.7%

41. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at 18 Months
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	145
Very Satisfied	63 23.4%
Satisfied	57 21.2%
Neither Satisfied or Dissatisfied	17 6.3%
Dissatisfied	7 2.6%
Very Dissatisfied	1 0.4%

42. Other Pre-specified Outcome

Title	Number of Participants With Patient Satisfaction at 24 Months
Description	Patient satisfaction will be summarized by count and percentage of participants
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Very Satisfied	55 20.4%
Satisfied	63 23.4%
Neither Satisfied or Dissatisfied	18 6.7%
Dissatisfied	4 1.5%
Very Dissatisfied	0 0%

43. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation
Description	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.
Time Frame	End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	244
No Change	18 6.7%
Almost the Same	7 2.6%
A little Better	6 2.2%
Somewhat Better	12 4.5%
Moderately Better	53 19.7%
Better	103 38.3%
A Great Deal Better	45 16.7%

44. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months
Description	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.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
No Change	13 4.8%
Almost the Same	12 4.5%
A little Better	20 7.4%
Somewhat Better	22 8.2%
Moderately Better	45 16.7%
Better	50 18.6%
A Great Deal Better	30 11.2%

45. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months
Description	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.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
No Change	12 4.5%
Almost the Same	16 5.9%
A little Better	15 5.6%
Somewhat Better	21 7.8%
Moderately Better	39 14.5%
Better	56 20.8%
A Great Deal Better	22 8.2%

46. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
No Change	9 3.3%
Almost the Same	8 3%
A little Better	15 5.6%
Somewhat Better	22 8.2%
Moderately Better	34 12.6%
Better	48 17.8%
A Great Deal Better	27 10%

47. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months
Description	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.
Time Frame	18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	145
No Change	7 2.6%
Almost the Same	10 3.7%
A little Better	11 4.1%
Somewhat Better	8 3%
Moderately Better	37 13.8%
Better	47 17.5%
A Great Deal Better	25 9.3%

48. Other Pre-specified Outcome

Title	Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months
Description	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.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
No Change	5 1.9%
Almost the Same	4 1.5%
A little Better	12 4.5%
Somewhat Better	13 4.8%
Moderately Better	39 14.5%
Better	40 14.9%
A Great Deal Better	27 10%

49. Other Pre-specified Outcome

Title	Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Description	Medication usage measured as decrease in chronic pain related medication intake since baseline
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Analgesic	37 13.8%
Anti-convulsant	25 9.3%
Muscle Relaxant	7 2.6%
Non-steroidal Anti-inflammatory Drug	10 3.7%
Opioid Medication	60 22.3%
Psychiatric Medication	10 3.7%

50. Other Pre-specified Outcome

Title	Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Description	Medication usage measured as decrease in chronic pain related medication intake since baseline
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
Analgesic	44 16.4%
Anti-convulsant	31 11.5%
Muscle Relaxant	4 1.5%
Non-steroidal Anti-inflammatory Drug	12 4.5%
Opioid Medication	62 23%
Psychiatric Medication	11 4.1%

51. Other Pre-specified Outcome

Title	Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Description	Medication usage measured as decrease in chronic pain related medication intake since baseline
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
Analgesic	45 16.7%
Anti-convulsant	31 11.5%
Muscle Relaxant	6 2.2%
Non-steroidal Anti-inflammatory Drug	13 4.8%
Opioid Medication	61 22.7%
Psychiatric Medication	11 4.1%

52. Other Pre-specified Outcome

Title	Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Description	Medication usage measured as decrease in chronic pain related medication intake since baseline
Time Frame	18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	145
Analgesic	44 16.4%
Anti-convulsant	31 11.5%
Muscle Relaxant	11 4.1%
Non-steroidal Anti-inflammatory Drug	15 5.6%
Opioid Medication	60 22.3%
Psychiatric Medication	16 5.9%

53. Other Pre-specified Outcome

Title	Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Description	Medication usage measured as decrease in chronic pain related medication intake since baseline
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	140
Analgesic	42 15.6%
Anti-convulsant	29 10.8%
Muscle Relaxant	9 3.3%
Non-steroidal Anti-inflammatory Drug	15 5.6%
Opioid Medication	51 19%
Psychiatric Medication	14 5.2%

54. Other Pre-specified Outcome

Title	Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Description	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Burning	6 2.2%
Buzzing/vibrating/Pulsing	23 8.6%
Cold	2 0.7%
Heaviness	2 0.7%
Itching	5 1.9%
Massaging/pressure	3 1.1%
Numbness	6 2.2%
Stinging/prickling	6 2.2%
Tickling	8 3%
Tingling	27 10%
Warm	3 1.1%
Other	0 0%

55. Other Pre-specified Outcome

Title	Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Description	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
Burning	3 1.1%
Buzzing/vibrating/Pulsing	18 6.7%
Cold	2 0.7%
Heaviness	4 1.5%
Itching	2 0.7%
Massaging/pressure	6 2.2%
Numbness	9 3.3%
Stinging/prickling	9 3.3%
Tickling	6 2.2%
Tingling	28 10.4%
Warm	2 0.7%
Other	0 0%

56. Other Pre-specified Outcome

Title	Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Description	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
Burning	1 0.4%
Buzzing/vibrating/Pulsing	13 4.8%
Cold	1 0.4%
Heaviness	3 1.1%
Itching	1 0.4%
Massaging/pressure	2 0.7%
Numbness	0 0%
Stinging/prickling	0 0%
Tickling	2 0.7%
Tingling	19 7.1%
Warm	1 0.4%
Other	2 0.7%

57. Other Pre-specified Outcome

Title	Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Description	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time Frame	18 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	146
Burning	2 0.7%
Buzzing/vibrating/Pulsing	13 4.8%
Cold	2 0.7%
Heaviness	0 0%
Itching	1 0.4%
Massaging/pressure	4 1.5%
Numbness	2 0.7%
Stinging/prickling	2 0.7%
Tickling	6 2.2%
Tingling	14 5.2%
Warm	3 1.1%
Other	3 1.1%

58. Other Pre-specified Outcome

Title	Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Description	The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	141
Burning	2 0.7%
Buzzing/vibrating/Pulsing	16 5.9%
Cold	1 0.4%
Heaviness	0 0%
Itching	2 0.7%
Massaging/pressure	7 2.6%
Numbness	3 1.1%
Stinging/prickling	3 1.1%
Tickling	5 1.9%
Tingling	20 7.4%
Warm	0 0%
Other	0 0%

59. Other Pre-specified Outcome

Title	Number of Patient Waveform Preference
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	192
Burst	169 62.8%
Tonic	23 8.6%

60. Other Pre-specified Outcome

Title	Number of Patient Waveform Preference
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	181
Burst	158 58.7%
Tonic	23 8.6%

61. Other Pre-specified Outcome

Title	Number of Patient Waveform Preference
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	163
Burst	142 52.8%
Tonic	21 7.8%

62. Other Pre-specified Outcome

Title	Number of Patient Waveform Preference
Description	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.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	144
Burst	123 45.7%
Tonic	21 7.8%

63. Other Pre-specified Outcome

Title	Number of Patient Waveform Preference
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	139
Burst	116 43.1%
Tonic	23 8.6%

64. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Frequency of Recharge
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	45
2-3 times a week	8 3%
Weekly	24 8.9%
Every other week	6 2.2%
Every three week	3 1.1%
Once a month or less often	4 1.5%

65. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Frequency of Recharge
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	39
2-3 times a week	8 3%
Weekly	16 5.9%
Every other week	8 3%
Every three week	2 0.7%
Once a month or less often	5 1.9%

66. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Frequency of Recharge
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	32
2-3 times a week	4 1.5%
Weekly	15 5.6%
Every other week	7 2.6%
Every three week	4 1.5%
Once a month or less often	2 0.7%

67. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Frequency of Recharge
Description	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
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	24
2-3 times a week	3 1.1%
Weekly	13 4.8%
Every other week	5 1.9%
Every three week	1 0.4%
Once a month or less often	2 0.7%

68. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Frequency of Recharge
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	25
2-3 times a week	3 1.1%
Weekly	11 4.1%
Every other week	6 2.2%
Every three week	1 0.4%
Once a month or less often	4 1.5%

69. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Duration of Recharge
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	45
Less than 30 Min	2 0.7%
30 Min to 1 Hour	13 4.8%
1 to 2 Hours	16 5.9%
2 to 3 Hours	9 3.3%
3 to 4 Hours	3 1.1%
4 to 5 Hours	1 0.4%
More than 5 Hours	1 0.4%

70. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Duration of Recharge
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	39
Less than 30 Min	1 0.4%
30 Min to 1 Hour	6 2.2%
1 to 2 Hours	18 6.7%
2 to 3 Hours	7 2.6%
3 to 4 Hours	5 1.9%
4 to 5 Hours	1 0.4%
More than 5 Hours	1 0.4%

71. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Duration of Recharge
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	32
Less than 30 Min	0 0%
30 Min to 1 Hour	1 0.4%
1 to 2 Hours	18 6.7%
2 to 3 Hours	7 2.6%
3 to 4 Hours	4 1.5%
4 to 5 Hours	2 0.7%
More than 5 Hours	0 0%

72. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Duration of Recharge
Description	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.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	24
Less than 30 Min	0 0%
30 Min to 1 Hour	3 1.1%
1 to 2 Hours	10 3.7%
2 to 3 Hours	7 2.6%
3 to 4 Hours	3 1.1%
4 to 5 Hours	1 0.4%
More than 5 Hours	0 0%

73. Other Pre-specified Outcome

Title	Recharging Activities- Number of Participants With Duration of Recharge
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
The number of participants analyzed includes subjects with a rechargeable device

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
Measure Participants	25
Less than 30 Min	0 0%
30 Min to 1 Hour	4 1.5%
1 to 2 Hours	4 1.5%
2 to 3 Hours	9 3.3%
3 to 4 Hours	4 1.5%
4 to 5 Hours	2 0.7%
More than 5 Hours	2 0.7%

Adverse Events

	All Enrolled Subjects
Time Frame	2 years
Adverse Event Reporting Description

Arm/Group Title	All Enrolled Subjects
Arm/Group Description	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
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	4/269 (1.5%)
Serious Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	18/269 (6.7%)
Cardiac disorders
Congestive Heart Failure	1/269 (0.4%)	1
Heart Attack	1/269 (0.4%)	1
General disorders
Death of Unknown Cause	1/269 (0.4%)	1
Fever	1/269 (0.4%)	1
Syncope and Bleeding After Colonoscopy	1/269 (0.4%)	1
Hepatobiliary disorders
Cholecystectomy	1/269 (0.4%)	1
Infections and infestations
Acute Appendicitis	1/269 (0.4%)	1
Aspiration Pneumonia	1/269 (0.4%)	1
Cellulitis of Left Upper Extremity	1/269 (0.4%)	1
Staph Infection	1/269 (0.4%)	1
Infection	1/269 (0.4%)	1
Injury, poisoning and procedural complications
Acute Respiratory Failure with Flash Pulmonary Edema	1/269 (0.4%)	1
Allergic or Rejection Response to Implant Materials	1/269 (0.4%)	1
Changes in Stimulation or Reduced Pain Relief Due to Lead Migration	2/269 (0.7%)	2
Hematoma	1/269 (0.4%)	1
Infection	5/269 (1.9%)	5
Keloid Infection	1/269 (0.4%)	2
Lead Fracture	1/269 (0.4%)	1
Oversedation	1/269 (0.4%)	1
Pain Below the Level of Implant	2/269 (0.7%)	2
Persistent Pain at The IPG Site	1/269 (0.4%)	1
Skin Erosion Around the Implant	1/269 (0.4%)	1
Skin Irritation at IPG Site	1/269 (0.4%)	1
Stimulation in Unwanted Places/Chest Wall Stimulation	1/269 (0.4%)	1
Weakness, Clumsiness, Numbness or Pain Below the Level of Implant	1/269 (0.4%)	1
Musculoskeletal and connective tissue disorders
Bone Fracture	2/269 (0.7%)	2
Carpal Tunnel Syndrome	1/269 (0.4%)	1
Nervous system disorders
Cerebral Infarction Due to Embolism of Unspecified Cerebral Artery	1/269 (0.4%)	1
Psychiatric disorders
Suicide Ideation	1/269 (0.4%)	1
Renal and urinary disorders
Acute Renal Failure	1/269 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/269 (0.4%)	1
Pulmonary Embolism	1/269 (0.4%)	1
Other (Not Including Serious) Adverse Events
	All Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	27/269 (10%)
Injury, poisoning and procedural complications
Broken Swift Lock Anchors	1/269 (0.4%)	1
Burning Pain at The IPG Site	1/269 (0.4%)	1
Cerebrospinal Fluid (CSF) Leakage	2/269 (0.7%)	2
Changes in Stimulation or Reduced Pain Relief Due to Lead Failure	4/269 (1.5%)	4
Changes in Stimulation or Reduced Pain Relief Due to Lead Migration	4/269 (1.5%)	4
Changes in Stimulation or Reduced Pain Relief Due to Loose Electrical Connections	2/269 (0.7%)	2
Chronic Pain Exacerbation Due to Battery Depletion	1/269 (0.4%)	1
Damage to Functionality/ Mechanical Integrity of IPG Resulting in Inability to Communicate with IPG	2/269 (0.7%)	2
Damage to IPG/Leads Causing System Fail Deliver Stimulation/Causing System Deliver Overstimulation	1/269 (0.4%)	1
Hematoma	1/269 (0.4%)	1
Inadequate Stimulation	1/269 (0.4%)	1
Increased Pain	1/269 (0.4%)	1
Infection	3/269 (1.1%)	3
Insufficient Pain Relief	1/269 (0.4%)	1
Persistent Pain at The IPG Site	3/269 (1.1%)	3
Persistent Pain at The Lead Site	1/269 (0.4%)	1
Stimulation in Unwanted Places/Chest Wall Stimulation	1/269 (0.4%)	1
Undesirable Changes in Stimulation Which May Be Due to Cellular Changes in Tissue Around Electrodes	1/269 (0.4%)	1
Weakness, Clumsiness, Numbness or Pain Below the Level of Implant	1/269 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/Title	Robyn Capobianco
Organization	Abbott
Phone	+15129343941
Email	robyn.capobianco@abbott.com

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT03082261

Other Study ID Numbers:

SJM-CIP-10145

First Posted:

Mar 17, 2017

Last Update Posted:

Jul 8, 2021

Last Verified:

Jul 1, 2021