PROLONG Prospective, Multi-center, Open-label, Post-market Study
- Conditions
- Chronic Pain
- Interventions
- Device: DRG StimulatorDevice: Burst-capable SCS system
- Registration Number
- NCT03908476
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects using DRG systems DRG Stimulator Dorsal root ganglion stimulation. Subjects using BurstDR SCS systems Burst-capable SCS system Spinal cord stimulation with a Burst waveform.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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 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 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 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 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 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 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 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 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 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.'
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.
Trial Locations
- Locations (21)
Nevada Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
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
Newport Beach Headache & Pain
🇺🇸Newport Beach, California, United States
Napa Valley Orthopedic Medical Group
🇺🇸Napa, California, United States
Spine & Nerve Diagnostic Center
🇺🇸Roseville, California, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Front Range Pain Medicine
🇺🇸Fort Collins, Colorado, United States
Pain Care, LLC
🇺🇸Stockbridge, Georgia, United States
Nura
🇺🇸Edina, Minnesota, United States
Ainsworth Institute of Pain Management
🇺🇸New York, New York, United States
Albany Medical College at Albany Medical Center
🇺🇸Albany, New York, United States
Northwest Brain & Spine
🇺🇸Bend, Oregon, United States
Center for Interventional Pain and Spine
🇺🇸Lancaster, Pennsylvania, United States
Allegheny General Hospital Department of Neurosurgery
🇺🇸Pittsburgh, Pennsylvania, United States
The Spine & Nerve Center of St. Francis Hospital
🇺🇸Charleston, West Virginia, United States
St. Mary's Hospital
🇺🇸Huntington, West Virginia, United States
Garden State Pain Control
🇺🇸Clifton, New Jersey, United States
Pacific Research Institute
🇺🇸San Francisco, California, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States