Back to resultsPROLONG Prospective, Multi-center, Open-label, Post-market Study (PROLONG)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Burst-capable SCS system
DRG Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Spinal cord stimulation, ABT-CIP-10277, BurstDR, SCS, DRG
Eligibility Criteria
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.
Sites / Locations
- Spanish Hills Interventional Pain Specialists
- Coastal Pain & Spinal Diagnostics Medical Group
- UC San Diego Center for Pain Medicine
- Napa Valley Orthopedic Medical Group
- Newport Beach Headache & Pain
- Spine & Nerve Diagnostic Center
- Pacific Research Institute
- Front Range Pain Medicine
- Boca Raton Regional Hospital
- Pain Care, LLC
- Brigham & Women's Hospital
- Nura
- Nevada Advanced Pain Specialists
- Garden State Pain Control
- Albany Medical College at Albany Medical Center
- Ainsworth Institute of Pain Management
- Northwest Brain & Spine
- Center for Interventional Pain and Spine
- Allegheny General Hospital Department of Neurosurgery
- The Spine & Nerve Center of St. Francis Hospital
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Subjects using BurstDR SCS systems
Subjects using DRG systems
Arm Description
Spinal cord stimulation with a Burst waveform.
Dorsal root ganglion stimulation.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.'
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.'
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.'
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.'
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.'
Change in Pain Condition-related Medication Use 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
Details will be collected regarding dosages and categories of pain-related medication.
Change in Pain Condition-related Medication Use 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
Details will be collected regarding dosages and categories of pain-related medication.
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Details will be collected regarding dosages and categories of pain-related medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03908476
Brief Title
PROLONG Prospective, Multi-center, Open-label, Post-market Study
Acronym
PROLONG
Official Title
PROLONG Prospective, Multi-center, Open-label, Post-market Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Spinal cord stimulation, ABT-CIP-10277, BurstDR, SCS, DRG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects using BurstDR SCS systems
Arm Type
Experimental
Arm Description
Spinal cord stimulation with a Burst waveform.
Arm Title
Subjects using DRG systems
Arm Type
Experimental
Arm Description
Dorsal root ganglion stimulation.
Intervention Type
Device
Intervention Name(s)
Burst-capable SCS system
Intervention Description
Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
Intervention Type
Device
Intervention Name(s)
DRG Stimulator
Intervention Description
Subjects will be implanted with a market-released Abbott DRG stimulation system.
Primary Outcome Measure Information:
Title
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
Description
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
Title
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
Description
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
Title
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
Description
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
Title
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
Description
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
Title
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
Description
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
Secondary Outcome Measure Information:
Title
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
Description
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
Title
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
Description
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
Title
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
Description
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
Title
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
Description
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
Title
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
Description
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
Title
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
Description
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
Title
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
Description
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
Title
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
Description
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
Title
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
Description
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
Title
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
Description
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
Title
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
Description
'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
Title
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
Description
'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
Title
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
Description
'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
Title
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
Description
'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
Title
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
Description
'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
Title
Change in Pain Condition-related Medication Use From Baseline to 3 Months
Description
Details will be collected regarding dosages and categories of pain-related medication.
Time Frame
From baseline to 3 months
Title
Change in Pain Condition-related Medication Use From Baseline to 6 Months
Description
Details will be collected regarding dosages and categories of pain-related medication.
Time Frame
From baseline to 6 months
Title
Change in Pain Condition-related Medication Use From Baseline to 12 Months
Description
Details will be collected regarding dosages and categories of pain-related medication.
Time Frame
From baseline to 12 months
Title
Change in Pain Condition-related Medication Use From Baseline to 18 Months
Description
Details will be collected regarding dosages and categories of pain-related medication.
Time Frame
From baseline to 18 months
Title
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Description
Details will be collected regarding dosages and categories of pain-related medication.
Time Frame
From baseline to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Fahey
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Spanish Hills Interventional Pain Specialists
City
Camarillo
State/Province
California
ZIP/Postal Code
93010
Country
United States
Facility Name
Coastal Pain & Spinal Diagnostics Medical Group
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
UC San Diego Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Napa Valley Orthopedic Medical Group
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Newport Beach Headache & Pain
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Spine & Nerve Diagnostic Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Pacific Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States
Facility Name
Front Range Pain Medicine
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pain Care, LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nura
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Nevada Advanced Pain Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Garden State Pain Control
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Albany Medical College at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Ainsworth Institute of Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Northwest Brain & Spine
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Allegheny General Hospital Department of Neurosurgery
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
The Spine & Nerve Center of St. Francis Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
St. Mary's Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PROLONG Prospective, Multi-center, Open-label, Post-market Study
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