An interventional study of Prodigy, Prodigy MRI or Proclaim Elite IPG in Chronic Pain and Intractable Pain, sponsored by Abbott Medical Devices. Completed at 22 sites in 7 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-08.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 19 studies in Chronic Pain by Abbott Medical Devices — 2 open to participants now, 2 under way, none of them phase 3. Chronic Pain · Abbott Medical Devices.
Among the 19 studies in Chronic Pain by Abbott Medical Devices, this one has the largest enrollment of the 12 interventional ones that give a count, is the only one that started in 2017, is one of 12 with no phase, and was the 13th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 269 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →2 of the 19 studies in Chronic Pain by Abbott Medical Devices are open now, in 9 countries. Each count lists the studies.
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2017.
Median enrollment 43 across the 12 interventional studies, 135 across the 7 observational. Of the 17 that completed or were terminated, 16 (94%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Chronic Pain by Abbott Medical Devices, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to 6 Months
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Time frame: Baseline to 6 Months
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Time frame: Baseline to 6 Months
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Time frame: Baseline to 6 Months
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Time frame: Baseline to 6 Months
Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Time frame: Baseline to 6 Months
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Time frame: Baseline to 6 Months
Mean Change in Physical Function From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Time frame: Baseline to 6 Months
Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Time frame: Baseline to 12 Months
Mean Change in Quality of Life From Baseline to 18 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Time frame: Baseline to 18 Months
Mean Change in Quality of Life From Baseline to 24 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Time frame: Baseline to 24 Months
Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Time frame: Baseline to 3 Months
Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Time frame: Baseline to 12 Months
Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Time frame: Baseline to 18 Months
Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Time frame: Baseline to 24 Months
Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Time frame: Baseline to 12 Months
Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Time frame: Baseline to 18 Months
Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Time frame: Baseline to 24 Months
Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Time frame: Baseline to 12 Months
Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Time frame: Baseline to 18 Months
Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Time frame: Baseline to 24 Months
Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Time frame: Baseline to 3 Months
Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Time frame: Baseline to 12 Months
Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Time frame: Baseline to 18 Months
Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Time frame: Baseline to 24 Months
Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Time frame: Baseline to 12 Months
Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Time frame: Baseline to 18 Months
Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Time frame: Baseline to 24 Months
Mean Change in Physical Function From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Time frame: Baseline to 12 Months
Mean Change in Physical Function From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Time frame: Baseline to 18 Months
Mean Change in Physical Function From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Time frame: Baseline to 24 Months
Mean Change in Pain From Baseline to End of Trial System (Post-permanent Implant), Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Mean Change in Pain From Baseline to 3 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to 3 Months
Mean Change in Pain From Baseline to 12 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to 12 Months
Mean Change in Pain From Baseline to 18 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to 18 Months
Mean Change in Pain From Baseline to 24 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Time frame: Baseline to 24 Months
Number of Participants With Patient Satisfaction at End of Trial System Evaluation
Patient satisfaction will be summarized by count and percentage of participants
Time frame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Number of Participants With Patient Satisfaction at 3 Months
Patient satisfaction will be summarized by count and percentage of participants
Time frame: 3 Months
Number of Participants With Patient Satisfaction at 6 Months
Patient satisfaction will be summarized by count and percentage of participants
Time frame: 6 Months
Number of Participants With Patient Satisfaction at 12 Months
Patient satisfaction will be summarized by count and percentage of participants
Time frame: 12 Months
Number of Participants With Patient Satisfaction at 18 Months
Patient satisfaction will be summarized by count and percentage of participants
Time frame: 18 Months
Number of Participants With Patient Satisfaction at 24 Months
Patient satisfaction will be summarized by count and percentage of participants
Time frame: 24 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: 3 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: 6 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: 12 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: 18 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
Time frame: 24 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Medication usage measured as decrease in chronic pain related medication intake since baseline
Time frame: 3 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Medication usage measured as decrease in chronic pain related medication intake since baseline
Time frame: 6 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Medication usage measured as decrease in chronic pain related medication intake since baseline
Time frame: 12 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Medication usage measured as decrease in chronic pain related medication intake since baseline
Time frame: 18 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Medication usage measured as decrease in chronic pain related medication intake since baseline
Time frame: 24 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time frame: 3 months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time frame: 6 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time frame: 12 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time frame: 18 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
Time frame: 24 Months
Number of Patient Waveform Preference
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
Time frame: 3 months
Number of Patient Waveform Preference
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
Time frame: 6 months
Number of Patient Waveform Preference
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
Time frame: 12 months
Number of Patient Waveform Preference
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
Time frame: 18 months
Number of Patient Waveform Preference
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
Time frame: 24 months
Recharging Activities- Number of Participants With Frequency of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 3 months
Recharging Activities- Number of Participants With Frequency of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 6 months
Recharging Activities- Number of Participants With Frequency of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 12 months
Recharging Activities- Number of Participants With Frequency of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants
Time frame: 18 months
Recharging Activities- Number of Participants With Frequency of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 24 months
Recharging Activities- Number of Participants With Duration of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 3 months
Recharging Activities- Number of Participants With Duration of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 6 months
Recharging Activities- Number of Participants With Duration of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 12 months
Recharging Activities- Number of Participants With Duration of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 18 months
Recharging Activities- Number of Participants With Duration of Recharge
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
Time frame: 24 months
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.
| Milestone | All Enrolled Subjects |
|---|---|
| Started | 269 |
| Completed | 149 |
| Not completed | 120 |
| Withdrew: Death | 4 |
| Withdrew: Implant of dorsal root ganglion stimulation (drg) device | 1 |
| Withdrew: Insurance denial | 1 |
| Withdrew: Peripheral lead added | 1 |
| Withdrew: Withdrawal by subject | 40 |
| Withdrew: Subject did not meet screening inclusion/exclusion criteria | 2 |
| Withdrew: Subject implanted with device other than study device | 1 |
| Withdrew: Lost to follow-up | 14 |
| Withdrew: Subject moved to a different state | 1 |
| Withdrew: Subject non-compliance | 2 |
| Withdrew: Subject participation terminated by investigator | 9 |
| Withdrew: Subject participation terminated by sponsor | 4 |
| Withdrew: System explant | 19 |
| Withdrew: Unable to place lead(s) | 2 |
| Withdrew: Unsuccessful trial evaluation period | 19 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.6 ± 1.1 |
| 6 months | 4.6 ± 2.4 |
| Change from baseline to 6 months | 3.0 ± 2.6 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 0.44 ± 0.22 |
| 6 months | 0.65 ± 0.21 |
| Change from baseline to 6 months | 0.21 ± 0.22 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 25.6 ± 12.9 |
| 6 months | 13.7 ± 12.2 |
| Change from baseline to 6 months | 11.9 ± 11.8 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 87.1 ± 26.1 |
| 6 months | 77.1 ± 24.7 |
| Change from baseline to 6 months | 10.0 ± 21.6 |
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).
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 10.5 ± 6.5 |
| 6 months | 7.6 ± 6.5 |
| Change from baseline to 6 months | 3.0 ± 5.5 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 28.7 ± 7.8 |
| 6 months | 24.9 ± 7.2 |
| Change from baseline to 6 months | 3.8 ± 6.7 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 52.6 ± 21.8 |
| 6 months | 45.0 ± 23.2 |
| Change from baseline to 6 months | 7.5 ± 18.8 |
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.
| T-score | All Enrolled Subjects |
|---|---|
| Baseline | 32.9 ± 5.0 |
| 6 months | 36.7 ± 6.8 |
| Change from baseline to 6 months | 3.8 ± 5.4 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 0.44 ± 0.21 |
| 12 months | 0.63 ± 0.23 |
| Change from baseline to 12 months | 0.20 ± 0.23 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 0.44 ± 0.21 |
| 18 months | 0.65 ± 0.20 |
| Change from baseline to 18 months | 0.22 ± 0.23 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 0.44 ± 0.21 |
| 24 months | 0.64 ± 0.21 |
| Change from baseline to 24 months | 0.21 ± 0.23 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 25.7 ± 13.1 |
| 3 months | 14.6 ± 12.3 |
| Change from baseline to 3 months | 10.6 ± 13.4 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 25.7 ± 13.1 |
| 12 months | 14.3 ± 13.1 |
| Change from baseline to 12 months | 11.3 ± 12.1 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 25.7 ± 13.1 |
| 18 months | 14.0 ± 11.5 |
| Change from baseline to 18 months | 12.4 ± 12.8 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 25.7 ± 13.1 |
| 24 months | 13.2 ± 12.6 |
| Change from baseline to 24 months | 12.5 ± 12.8 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 87.5 ± 26.2 |
| 12 months | 77.3 ± 26.9 |
| Change from baseline to 12 months | 9.3 ± 22.2 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 87.5 ± 26.2 |
| 18 months | 75.1 ± 24.9 |
| Change from baseline to 18 months | 11.4 ± 21.4 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 87.5 ± 26.2 |
| 24 months | 75.5 ± 26.7 |
| Change from baseline to 24 months | 10.8 ± 21.7 |
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).
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 10.2 ± 6.5 |
| 12 months | 7.7 ± 6.6 |
| Change from baseline to 12 months | 2.8 ± 5.6 |
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).
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 10.2 ± 6.5 |
| 18 months | 6.9 ± 5.8 |
| Change from baseline to 18 months | 3.7 ± 6.4 |
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).
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 10.2 ± 6.5 |
| 24 months | 7.5 ± 6.4 |
| Change from baseline to 24 months | 3.0 ± 6.1 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 28.7 ± 7.7 |
| 3 months | 24.6 ± 7.2 |
| Change from baseline to 3 months | 3.8 ± 7.5 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 28.7 ± 7.7 |
| 12 months | 24.4 ± 7.2 |
| Change from baseline to 12 months | 4.3 ± 7.1 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 28.7 ± 7.7 |
| 18 months | 24.3 ± 7.4 |
| Change from baseline to 18 months | 4.8 ± 7.5 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 28.7 ± 7.7 |
| 24 months | 25.2 ± 7.5 |
| Change from baseline to 24 months | 4.2 ± 7.6 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 50.3 ± 22.6 |
| 12 months | 45.4 ± 23.5 |
| Change from baseline to 12 months | 7.6 ± 20.0 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 50.3 ± 22.6 |
| 18 months | 43.8 ± 23.8 |
| Change from baseline to 18 months | 9.9 ± 20.6 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 50.3 ± 22.6 |
| 24 months | 43.2 ± 22.1 |
| Change from baseline to 24 months | 10.8 ± 20.7 |
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.
| T-score | All Enrolled Subjects |
|---|---|
| Baseline | 33.0 ± 5.2 |
| 12 months | 36.3 ± 6.6 |
| Change from baseline to 12 months | 3.2 ± 5.4 |
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.
| T-score | All Enrolled Subjects |
|---|---|
| Baseline | 33.0 ± 5.2 |
| 18 months | 37.1 ± 6.3 |
| Change from baseline to 18 months | 3.7 ± 6.1 |
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.
| T-score | All Enrolled Subjects |
|---|---|
| Baseline | 33.0 ± 5.2 |
| 24 months | 36.9 ± 7.6 |
| Change from baseline to 24 months | 3.8 ± 6.8 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.7 ± 1.2 |
| End of trial | 3.5 ± 2.1 |
| Change from baseline to end of trial | 4.2 ± 2.3 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.7 ± 1.2 |
| 3 months | 4.4 ± 2.4 |
| Change from baseline to 3 months | 3.3 ± 2.5 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.7 ± 1.2 |
| 12 months | 4.7 ± 2.5 |
| Change from baseline to 12 months | 2.9 ± 2.5 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.7 ± 1.2 |
| 18 months | 4.5 ± 2.5 |
| Change from baseline to 18 months | 3.1 ± 2.6 |
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.
| score on a scale | All Enrolled Subjects |
|---|---|
| Baseline | 7.7 ± 1.2 |
| 24 months | 4.8 ± 2.5 |
| Change from baseline to 24 months | 2.8 ± 2.6 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 125 |
| Satisfied | 94 |
| Neither Satisfied or Dissatisfied | 7 |
| Dissatisfied | 10 |
| Very Dissatisfied | 8 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 72 |
| Satisfied | 75 |
| Neither Satisfied or Dissatisfied | 31 |
| Dissatisfied | 14 |
| Very Dissatisfied | 0 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 67 |
| Satisfied | 68 |
| Neither Satisfied or Dissatisfied | 34 |
| Dissatisfied | 11 |
| Very Dissatisfied | 1 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 58 |
| Satisfied | 75 |
| Neither Satisfied or Dissatisfied | 21 |
| Dissatisfied | 7 |
| Very Dissatisfied | 2 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 63 |
| Satisfied | 57 |
| Neither Satisfied or Dissatisfied | 17 |
| Dissatisfied | 7 |
| Very Dissatisfied | 1 |
Patient satisfaction will be summarized by count and percentage of participants
| Participants | All Enrolled Subjects |
|---|---|
| Very Satisfied | 55 |
| Satisfied | 63 |
| Neither Satisfied or Dissatisfied | 18 |
| Dissatisfied | 4 |
| Very Dissatisfied | 0 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 18 |
| Almost the Same | 7 |
| A little Better | 6 |
| Somewhat Better | 12 |
| Moderately Better | 53 |
| Better | 103 |
| A Great Deal Better | 45 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 13 |
| Almost the Same | 12 |
| A little Better | 20 |
| Somewhat Better | 22 |
| Moderately Better | 45 |
| Better | 50 |
| A Great Deal Better | 30 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 12 |
| Almost the Same | 16 |
| A little Better | 15 |
| Somewhat Better | 21 |
| Moderately Better | 39 |
| Better | 56 |
| A Great Deal Better | 22 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 9 |
| Almost the Same | 8 |
| A little Better | 15 |
| Somewhat Better | 22 |
| Moderately Better | 34 |
| Better | 48 |
| A Great Deal Better | 27 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 7 |
| Almost the Same | 10 |
| A little Better | 11 |
| Somewhat Better | 8 |
| Moderately Better | 37 |
| Better | 47 |
| A Great Deal Better | 25 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| No Change | 5 |
| Almost the Same | 4 |
| A little Better | 12 |
| Somewhat Better | 13 |
| Moderately Better | 39 |
| Better | 40 |
| A Great Deal Better | 27 |
Medication usage measured as decrease in chronic pain related medication intake since baseline
| Participants | All Enrolled Subjects |
|---|---|
| Analgesic | 37 |
| Anti-convulsant | 25 |
| Muscle Relaxant | 7 |
| Non-steroidal Anti-inflammatory Drug | 10 |
| Opioid Medication | 60 |
| Psychiatric Medication | 10 |
Medication usage measured as decrease in chronic pain related medication intake since baseline
| Participants | All Enrolled Subjects |
|---|---|
| Analgesic | 44 |
| Anti-convulsant | 31 |
| Muscle Relaxant | 4 |
| Non-steroidal Anti-inflammatory Drug | 12 |
| Opioid Medication | 62 |
| Psychiatric Medication | 11 |
Medication usage measured as decrease in chronic pain related medication intake since baseline
| Participants | All Enrolled Subjects |
|---|---|
| Analgesic | 45 |
| Anti-convulsant | 31 |
| Muscle Relaxant | 6 |
| Non-steroidal Anti-inflammatory Drug | 13 |
| Opioid Medication | 61 |
| Psychiatric Medication | 11 |
Medication usage measured as decrease in chronic pain related medication intake since baseline
| Participants | All Enrolled Subjects |
|---|---|
| Analgesic | 44 |
| Anti-convulsant | 31 |
| Muscle Relaxant | 11 |
| Non-steroidal Anti-inflammatory Drug | 15 |
| Opioid Medication | 60 |
| Psychiatric Medication | 16 |
Medication usage measured as decrease in chronic pain related medication intake since baseline
| Participants | All Enrolled Subjects |
|---|---|
| Analgesic | 42 |
| Anti-convulsant | 29 |
| Muscle Relaxant | 9 |
| Non-steroidal Anti-inflammatory Drug | 15 |
| Opioid Medication | 51 |
| Psychiatric Medication | 14 |
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
| Participants | All Enrolled Subjects |
|---|---|
| Burning | 6 |
| Buzzing/vibrating/Pulsing | 23 |
| Cold | 2 |
| Heaviness | 2 |
| Itching | 5 |
| Massaging/pressure | 3 |
| Numbness | 6 |
| Stinging/prickling | 6 |
| Tickling | 8 |
| Tingling | 27 |
| Warm | 3 |
| Other | 0 |
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
| Participants | All Enrolled Subjects |
|---|---|
| Burning | 3 |
| Buzzing/vibrating/Pulsing | 18 |
| Cold | 2 |
| Heaviness | 4 |
| Itching | 2 |
| Massaging/pressure | 6 |
| Numbness | 9 |
| Stinging/prickling | 9 |
| Tickling | 6 |
| Tingling | 28 |
| Warm | 2 |
| Other | 0 |
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
| Participants | All Enrolled Subjects |
|---|---|
| Burning | 1 |
| Buzzing/vibrating/Pulsing | 13 |
| Cold | 1 |
| Heaviness | 3 |
| Itching | 1 |
| Massaging/pressure | 2 |
| Numbness | 0 |
| Stinging/prickling | 0 |
| Tickling | 2 |
| Tingling | 19 |
| Warm | 1 |
| Other | 2 |
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
| Participants | All Enrolled Subjects |
|---|---|
| Burning | 2 |
| Buzzing/vibrating/Pulsing | 13 |
| Cold | 2 |
| Heaviness | 0 |
| Itching | 1 |
| Massaging/pressure | 4 |
| Numbness | 2 |
| Stinging/prickling | 2 |
| Tickling | 6 |
| Tingling | 14 |
| Warm | 3 |
| Other | 3 |
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
| Participants | All Enrolled Subjects |
|---|---|
| Burning | 2 |
| Buzzing/vibrating/Pulsing | 16 |
| Cold | 1 |
| Heaviness | 0 |
| Itching | 2 |
| Massaging/pressure | 7 |
| Numbness | 3 |
| Stinging/prickling | 3 |
| Tickling | 5 |
| Tingling | 20 |
| Warm | 0 |
| Other | 0 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Burst | 169 |
| Tonic | 23 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Burst | 158 |
| Tonic | 23 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Burst | 142 |
| Tonic | 21 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Burst | 123 |
| Tonic | 21 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Burst | 116 |
| Tonic | 23 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| 2-3 times a week | 8 |
| Weekly | 24 |
| Every other week | 6 |
| Every three week | 3 |
| Once a month or less often | 4 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| 2-3 times a week | 8 |
| Weekly | 16 |
| Every other week | 8 |
| Every three week | 2 |
| Once a month or less often | 5 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| 2-3 times a week | 4 |
| Weekly | 15 |
| Every other week | 7 |
| Every three week | 4 |
| Once a month or less often | 2 |
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
| Participants | All Enrolled Subjects |
|---|---|
| 2-3 times a week | 3 |
| Weekly | 13 |
| Every other week | 5 |
| Every three week | 1 |
| Once a month or less often | 2 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| 2-3 times a week | 3 |
| Weekly | 11 |
| Every other week | 6 |
| Every three week | 1 |
| Once a month or less often | 4 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Less than 30 Min | 2 |
| 30 Min to 1 Hour | 13 |
| 1 to 2 Hours | 16 |
| 2 to 3 Hours | 9 |
| 3 to 4 Hours | 3 |
| 4 to 5 Hours | 1 |
| More than 5 Hours | 1 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Less than 30 Min | 1 |
| 30 Min to 1 Hour | 6 |
| 1 to 2 Hours | 18 |
| 2 to 3 Hours | 7 |
| 3 to 4 Hours | 5 |
| 4 to 5 Hours | 1 |
| More than 5 Hours | 1 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Less than 30 Min | 0 |
| 30 Min to 1 Hour | 1 |
| 1 to 2 Hours | 18 |
| 2 to 3 Hours | 7 |
| 3 to 4 Hours | 4 |
| 4 to 5 Hours | 2 |
| More than 5 Hours | 0 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Less than 30 Min | 0 |
| 30 Min to 1 Hour | 3 |
| 1 to 2 Hours | 10 |
| 2 to 3 Hours | 7 |
| 3 to 4 Hours | 3 |
| 4 to 5 Hours | 1 |
| More than 5 Hours | 0 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Less than 30 Min | 0 |
| 30 Min to 1 Hour | 4 |
| 1 to 2 Hours | 4 |
| 2 to 3 Hours | 9 |
| 3 to 4 Hours | 4 |
| 4 to 5 Hours | 2 |
| More than 5 Hours | 2 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Subjects | 4/269 (1.5%) | 18/269 (6.7%) | 27/269 (10%) |
| Event | All Enrolled Subjects |
|---|---|
| InfectionInjury, poisoning and procedural complications | 5/269 |
| Changes in Stimulation or Reduced Pain Relief Due to Lead MigrationInjury, poisoning and procedural complications | 2/269 |
| Pain Below the Level of ImplantInjury, poisoning and procedural complications | 2/269 |
| Bone FractureMusculoskeletal and connective tissue disorders | 2/269 |
| Acute Respiratory Failure with Flash Pulmonary EdemaInjury, poisoning and procedural complications | 1/269 |
| Allergic or Rejection Response to Implant MaterialsInjury, poisoning and procedural complications | 1/269 |
| HematomaInjury, poisoning and procedural complications | 1/269 |
| Keloid InfectionInjury, poisoning and procedural complications | 1/269 |
| Lead FractureInjury, poisoning and procedural complications | 1/269 |
| OversedationInjury, poisoning and procedural complications | 1/269 |
| Event | All Enrolled Subjects |
|---|---|
| Changes in Stimulation or Reduced Pain Relief Due to Lead FailureInjury, poisoning and procedural complications | 4/269 |
| Changes in Stimulation or Reduced Pain Relief Due to Lead MigrationInjury, poisoning and procedural complications | 4/269 |
| InfectionInjury, poisoning and procedural complications | 3/269 |
| Persistent Pain at The IPG SiteInjury, poisoning and procedural complications | 3/269 |
| Cerebrospinal Fluid (CSF) LeakageInjury, poisoning and procedural complications | 2/269 |
| Changes in Stimulation or Reduced Pain Relief Due to Loose Electrical ConnectionsInjury, poisoning and procedural complications | 2/269 |
| Damage to Functionality/ Mechanical Integrity of IPG Resulting in Inability to Communicate with IPGInjury, poisoning and procedural complications | 2/269 |
| Broken Swift Lock AnchorsInjury, poisoning and procedural complications | 1/269 |
| Burning Pain at The IPG SiteInjury, poisoning and procedural complications | 1/269 |
| Chronic Pain Exacerbation Due to Battery DepletionInjury, poisoning and procedural complications | 1/269 |
| Age, Continuous(years) | All Enrolled Subjects |
|---|---|
| Mean | 59.4 ± 13.6 |
| Sex: Female, Male(Participants) | All Enrolled Subjects |
|---|---|
| Female | 166 |
| Male | 103 |
| Race and Ethnicity Not Collected(Participants) | All Enrolled Subjects |
|---|
| Region of Enrollment(participants) | All Enrolled Subjects |
|---|---|
| Canada | 7 |
| United States | 210 |
| Finland | 12 |
| Italy | 8 |
| Switzerland | 1 |
| Germany | 5 |
| Spain | 26 |
| Duration of Experiencing Chronic Pain(years) | All Enrolled Subjects |
|---|---|
| Mean | 9.7 ± 8.6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2017 to primary completion in Jan 2019, 22 months.
Results were first posted in Jun 2021, 2 years 4 months after primary completion.
Of 83 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 22 months is close to that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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