Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
Subjects will be implanted with a market-released Abbott DRG stimulation system.
Spanish Hills Interventional Pain Specialists
Camarillo, California, United States
Coastal Pain & Spinal Diagnostics Medical Group
Carlsbad, California, United States
UC San Diego Center for Pain Medicine
La Jolla, California, United States
Napa Valley Orthopedic Medical Group
Napa, California, United States
Newport Beach Headache & Pain
Newport Beach, California, United States
Spine & Nerve Diagnostic Center
Roseville, California, United States
Pacific Research Institute
San Francisco, California, United States
Front Range Pain Medicine
Fort Collins, Colorado, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Pain Care, LLC
Stockbridge, Georgia, United States
...and 11 more locations
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Time frame: From Baseline to 3 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Time frame: From Baseline to 6 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Time frame: From Baseline to 12 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Time frame: From Baseline to 18 months
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Time frame: From Baseline to 24 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Time frame: From baseline to 3 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Time frame: From baseline to 6 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Time frame: From baseline to 12 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Time frame: From baseline to 18 months
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.
Time frame: From baseline to 24 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Time frame: From baseline to 3 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Time frame: From baseline to 6 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Time frame: From baseline to 12 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Time frame: From baseline to 18 months
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.
Time frame: From baseline to 24 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Time frame: From baseline to 3 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Time frame: From baseline to 6 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Time frame: From baseline to 12 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Time frame: From baseline to 18 months
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'
Time frame: From baseline to 24 months
Change in Pain Condition-related Medication Use From Baseline to 3 Months
Details will be collected regarding dosages and categories of pain-related medication.
Time frame: From baseline to 3 months
Change in Pain Condition-related Medication Use From Baseline to 6 Months
Details will be collected regarding dosages and categories of pain-related medication.
Time frame: From baseline to 6 months
Change in Pain Condition-related Medication Use From Baseline to 12 Months
Details will be collected regarding dosages and categories of pain-related medication.
Time frame: From baseline to 12 months
Change in Pain Condition-related Medication Use From Baseline to 18 Months
Details will be collected regarding dosages and categories of pain-related medication.
Time frame: From baseline to 18 months
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Details will be collected regarding dosages and categories of pain-related medication.
Time frame: From baseline to 24 months
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