PROLONG Prospective, Multi-center, Open-label, Post-market Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This study will examine the utility of Abbott neurostimulation devices for restoring therapeutic benefit from neuromodulation therapy. These devices include programming the BurstDR waveform in an enabled implantable pulse generator (IPG), and dorsal root ganglion stimulation (Proclaim DRG). The BurstDR waveform offers a unique mechanism of action that may explain why it can restore efficacy where tonic stimulation has failed. While all forms of SCS activate the lateral pain pathway, which is responsible for the sensory aspects of pain, only BurstDR has been shown to activate the medial pain pathway which is responsible for the affective components. It is this medial activation that may allow BurstDR to succeed despite psychological factors such as catastrophizing and depression. Additionally, it is possible that BurstDR may be less susceptible to habituation because it more closely mimics natural thalamic firing.
Several different methods of implementing BurstDR may be included in this investigation to account for a range of possible existing systems and patient needs. It can be implemented by reprogramming a BurstDR-capable device, connecting a BurstDR-capable IPG to existing leads with an adapter or compatible header, or through full system replacement.
While traditional SCS applies stimulation to the dorsal horn of the spinal cord, DRG stimulation targets a bundle of sensory nerve cell bodies just outside of the spinal cord known as the dorsal root ganglion. This form of stimulation has been shown to make it easier to achieve pain-paresthesia overlap, provide consistent stimulation irrespective of body position, and produce paresthesia with a lower current than traditional SCS. Using DRG stimulation as a replacement or supplement to SCS may ensure reliable coverage of the entire painful area and improve pain outcomes.
This is the first prospective investigation designed to evaluate the effectiveness of Abbott neurostimulation devices for restoring pain relief in patients with waning or failed therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects using BurstDR SCS systems Spinal cord stimulation with a Burst waveform. |
Device: Burst-capable SCS system
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
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| Experimental: Subjects using DRG systems Dorsal root ganglion stimulation. |
Device: DRG Stimulator
Subjects will be implanted with a market-released Abbott DRG stimulation system.
|
Outcome Measures
Primary Outcome Measures
- Mean change in pain assessed by Numerical Rating Scale (NRS) from baseline to 3 months [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.
- Mean change in pain assessed by Numerical Rating Scale (NRS) from baseline to 6 months [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.
- Mean change in pain assessed by Numerical Rating Scale (NRS) from baseline to 12 months [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.
- Mean change in pain assessed by Numerical Rating Scale (NRS) from baseline to 18 months [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.
- Mean change in pain assessed by Numerical Rating Scale (NRS) from baseline to 24 months [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.
Secondary Outcome Measures
- Mean change in health domains assessed by PROMIS-29 Scale from baseline to 3 months [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.
- Mean change in health domains assessed by PROMIS-29 Scale from baseline to 6 months [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.
- Mean change in health domains assessed by PROMIS-29 Scale from baseline to 12 months [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.
- Mean change in health domains assessed by PROMIS-29 Scale from baseline to 18 months [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.
- Mean change in health domains assessed by PROMIS-29 Scale from baseline to 24 months [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.
- Mean change in pain assessed by Pain Catastrophizing Scale (PCS) from baseline to 3 months [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.
- Mean change in pain assessed by Pain Catastrophizing Scale (PCS) from baseline to 6 months [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.
- Mean change in pain assessed by Pain Catastrophizing Scale (PCS) from baseline to 12 months [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.
- Mean change in pain assessed by Pain Catastrophizing Scale (PCS) from baseline to 18 months [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.
- Mean change in pain assessed by Pain Catastrophizing Scale (PCS) from baseline to 24 months [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.
- Mean change in attention to pain assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) from baseline to 3 months [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.'
- Mean change in attention to pain assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) from baseline to 6 months [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.'
- Mean change in attention to pain assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) from baseline to 12 months [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.'
- Mean change in attention to pain assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) from baseline to 18 months [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.'
- Mean change in attention to pain assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) from baseline to 24 months [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.'
- Mean change in Patient Reported Pain Relief [From baseline to end of trial, approximately 3-5 days]
A report of pain relief from 0% to 100%.
- Change in pain condition-related medication use from baseline to 3 months [From baseline to 3 months]
Details will be collected regarding dosages and categories of pain-related medication.
- Change in pain condition-related medication use from baseline to 6 months [From baseline to 6 months]
Details will be collected regarding dosages and categories of pain-related medication.
- Change in pain condition-related medication use from baseline to 12 months [From baseline to 12 months]
Details will be collected regarding dosages and categories of pain-related medication.
- Change in pain condition-related medication use from baseline to 18 months [From baseline to 18 months]
Details will be collected regarding dosages and categories of pain-related medication.
- Change in pain condition-related medication use from baseline to 24 months [From baseline to 24 months]
Details will be collected regarding dosages and categories of pain-related medication.
- Number of participants with Therapy-related satisfaction from baseline to 3 months [From baseline to 3 months]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
- Number of participants with Therapy-related satisfaction from baseline to 6 months [From baseline to 6 months]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
- Number of participants with Therapy-related satisfaction from baseline to 12 months [From baseline to 12 months]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
- Number of participants with Therapy-related satisfaction from baseline to 18 months [From baseline to 18 months]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
- Number of participants with Therapy-related satisfaction from baseline to 24 months [From baseline to 24 months]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
- Number of participants with Therapy-related satisfaction from baseline to End of Trial [From baseline to end of trial, approximately 3-5 days]
Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient must provide written informed consent prior to any clinical investigation related procedure.
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Patient has a spinal cord stimulator implanted for chronic, intractable pain.
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Patient has inadequate pain relief from their current SCS system.
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Patient has a pain NRS ≥ 6.
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Physician has determined that the patient's original pain is still addressable with neurostimulation.
Exclusion Criteria:
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Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
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Patient is seeking care for a new pain complaint outside of the original indication for SCS.
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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.
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Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
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Patient requires frequent MRI.
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Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
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Patient is part of a vulnerable population.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spanish Hills Interventional Pain Specialists | Camarillo | California | United States | 93010 |
| 2 | Coastal Pain & Spinal Diagnostics Medical Group | Carlsbad | California | United States | 92009 |
| 3 | UC San Diego Center for Pain Medicine | La Jolla | California | United States | 92093 |
| 4 | Napa Valley Orthopedic Medical Group | Napa | California | United States | 94558 |
| 5 | Newport Beach Headache & Pain | Newport Beach | California | United States | 92660 |
| 6 | Spine & Nerve Diagnostic Center | Roseville | California | United States | 95661 |
| 7 | Pacific Research Institute | Santa Rosa | California | United States | 95403 |
| 8 | Front Range Pain Medicine | Fort Collins | Colorado | United States | 80528 |
| 9 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
| 10 | Pain Care, LLC | Stockbridge | Georgia | United States | 30281 |
| 11 | Nura | Edina | Minnesota | United States | 55435 |
| 12 | Nevada Advanced Pain Specialists | Reno | Nevada | United States | 89511 |
| 13 | Albany Medical College at Albany Medical Center | Albany | New York | United States | 12208 |
| 14 | Ainsworth Institute of Pain Management | New York | New York | United States | 10022 |
| 15 | Northwest Brain & Spine | Bend | Oregon | United States | 97701 |
| 16 | Center for Interventional Pain and Spine | Lancaster | Pennsylvania | United States | 17601 |
| 17 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 18 | The Spine & Nerve Center of St. Francis Hospital | Charleston | West Virginia | United States | 25301 |
| 19 | St. Mary's Hospital | Huntington | West Virginia | United States | 25702 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Marie Fahey, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABT-CIP-10277