PROLONG Prospective, Multi-center, Open-label, Post-market Study

Study Overview
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Brief Summary
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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.

Official Title
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PROLONG Prospective, Multi-center, Open-label, Post-market Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Burst-capable SCS system
* Device: DRG Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must provide written informed consent prior to any clinical investigation related procedure. Patient has a spinal cord stimulator implanted for chronic, intractable pain. Patient has inadequate pain relief from their current SCS system. Patient has a pain NRS ≥ 6. Physician has determined that the patient's original pain is still addressable with neurostimulation. Exclusion Criteria: Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott. Patient is seeking care for a new pain complaint outside of the original indication for SCS. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements. Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system. Patient requires frequent MRI. Patient is involved in active disability litigation related to their pain or seeking worker's compensation. Patient is part of a vulnerable population.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects using BurstDR SCS systems<br>Spinal cord stimulation with a Burst waveform. | Device: Burst-capable SCS system<br>* Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.<br>|
| Experimental: Subjects using DRG systems<br>Dorsal root ganglion stimulation. | Device: DRG Stimulator<br>* Subjects will be implanted with a market-released Abbott DRG stimulation system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | From Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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.' | 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.' | 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.' | 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.' | 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.' | 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. | 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. | 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. | 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. | 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. | From baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Spinal cord stimulation, ABT-CIP-10277, BurstDR, SCS, DRG