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CompletedNCT03908476PROLONGUpdated Aug 1, 2023Results posted

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

An interventional study of Burst-capable SCS system and DRG Stimulator in Chronic Pain, sponsored by Abbott Medical Devices. Completed at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

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Keywords

  • Chronic Pain
  • Spinal cord stimulation
  • ABT-CIP-10277
  • BurstDR
  • SCS
  • DRG
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 118 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient must provide written informed consent prior to any clinical investigation related procedure.
  2. Patient has a spinal cord stimulator implanted for chronic, intractable pain.
  3. Patient has inadequate pain relief from their current SCS system.
  4. Patient has a pain NRS ≥ 6.
  5. Physician has determined that the patient's original pain is still addressable with neurostimulation.

Exclusion criteria

Exclusion Criteria:

  1. Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
  2. Patient is seeking care for a new pain complaint outside of the original indication for SCS.
  3. 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.
  4. Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
  5. Patient requires frequent MRI.
  6. Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
  7. Patient is part of a vulnerable population.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Subjects using BurstDR SCS systems

    Spinal cord stimulation with a Burst waveform.

    Device: Burst-capable SCS system

  • Experimental
    Subjects using DRG systems

    Dorsal root ganglion stimulation.

    Device: DRG Stimulator

Interventions

  • DeviceBurst-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.

  • DeviceDRG Stimulator

    Subjects will be implanted with a market-released Abbott DRG stimulation system.

06

What researchers measure

Primary outcomes

  1. Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months

    Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

    Time frame: From Baseline to 3 months

  2. Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months

    Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

    Time frame: From Baseline to 6 months

  3. Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months

    Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

    Time frame: From Baseline to 12 months

  4. Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months

    Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

    Time frame: From Baseline to 18 months

  5. Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months

    Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

    Time frame: From Baseline to 24 months

Secondary outcomes

  1. Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months

    Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

    Time frame: From baseline to 3 months

  2. Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months

    Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

    Time frame: From baseline to 6 months

  3. Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months

    Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

    Time frame: From baseline to 12 months

  4. Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months

    Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

    Time frame: From baseline to 18 months

  5. Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months

    Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

    Time frame: From baseline to 24 months

  6. Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months

    The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

    Time frame: From baseline to 3 months

  7. Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months

    The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

    Time frame: From baseline to 6 months

  8. Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months

    The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

    Time frame: From baseline to 12 months

  9. Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months

    The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

    Time frame: From baseline to 18 months

  10. Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months

    The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

    Time frame: From baseline to 24 months

  11. Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months

    'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

    Time frame: From baseline to 3 months

  12. Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months

    'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

    Time frame: From baseline to 6 months

  13. Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months

    'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

    Time frame: From baseline to 12 months

  14. Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months

    'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

    Time frame: From baseline to 18 months

  15. Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months

    'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

    Time frame: From baseline to 24 months

  16. Change in Pain Condition-related Medication Use From Baseline to 3 Months

    Details will be collected regarding dosages and categories of pain-related medication.

    Time frame: From baseline to 3 months

  17. Change in Pain Condition-related Medication Use From Baseline to 6 Months

    Details will be collected regarding dosages and categories of pain-related medication.

    Time frame: From baseline to 6 months

  18. Change in Pain Condition-related Medication Use From Baseline to 12 Months

    Details will be collected regarding dosages and categories of pain-related medication.

    Time frame: From baseline to 12 months

  19. Change in Pain Condition-related Medication Use From Baseline to 18 Months

    Details will be collected regarding dosages and categories of pain-related medication.

    Time frame: From baseline to 18 months

  20. Change in Pain Condition-related Medication Use From Baseline to 24 Months

    Details will be collected regarding dosages and categories of pain-related medication.

    Time frame: From baseline to 24 months

07

Results

Posted Jan 25, 2023

Participant flow

100 subjects proceeded with a permanent implant

Participant flow — Overall Study
MilestoneSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Started8515
Completed6413
Not completed212
Withdrew: Death30
Withdrew: Lost to follow-up31
Withdrew: Withdrawal by subject71
Withdrew: Physician decision20
Withdrew: System explanted and not replaced40
Withdrew: Intrathecal pump10
Withdrew: Patient has requested an explant of the device10

Outcome measures

PrimaryMean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Time frame:
From Baseline to 3 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months2.3 ± 2.53.3 ± 2.7
PrimaryMean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Time frame:
From Baseline to 6 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months2.5 ± 2.73.1 ± 3.5
PrimaryMean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Time frame:
From Baseline to 12 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months2.5 ± 2.62.6 ± 3.3
PrimaryMean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Time frame:
From Baseline to 18 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months2.2 ± 2.51.5 ± 3.6
PrimaryMean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Time frame:
From Baseline to 24 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months2.8 ± 2.62.0 ± 2.4
SecondaryMean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months

Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

Time frame:
From baseline to 3 months
Reported as:
Mean · score on a scale
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Physical Function-2.72 ± 5.63-4.90 ± 7.93
Anxiety2.36 ± 8.811.05 ± 7.18
Depression3.02 ± 9.472.43 ± 9.12
Fatigue3.03 ± 9.917.51 ± 6.87
Sleep Disturbance4.08 ± 8.002.99 ± 10.91
Social Roles and Activities-3.25 ± 8.36-4.54 ± 11.52
Pain Interference5.00 ± 7.875.56 ± 9.25
Pain Intensity1.9 ± 2.42.9 ± 2.3
SecondaryMean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months

Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

Time frame:
From baseline to 6 months
Reported as:
Mean · score on a scale
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Physical Function-2.21 ± 5.28-5.30 ± 8.64
Anxiety2.99 ± 7.64-0.96 ± 11.25
Depression2.52 ± 8.74-1.78 ± 9.83
Fatigue3.03 ± 9.554.81 ± 12.37
Sleep Disturbance4.73 ± 9.594.23 ± 13.32
Social Roles and Activities-2.76 ± 8.04-4.49 ± 11.29
Pain Interference5.32 ± 7.446.59 ± 9.54
Pain Intensity2.2 ± 2.43.0 ± 3.2
SecondaryMean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months

Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

Time frame:
From baseline to 12 months
Reported as:
Mean · score on a scale
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Physical Function-2.28 ± 5.74-5.97 ± 8.01
Anxiety1.96 ± 9.862.68 ± 12.71
Depression1.05 ± 10.140.30 ± 11.43
Fatigue3.38 ± 8.724.19 ± 10.76
Sleep Disturbance3.44 ± 8.832.81 ± 12.24
Social Roles and Activities-2.13 ± 8.36-4.99 ± 11.01
Pain Interference4.68 ± 7.946.46 ± 11.16
Pain Intensity2.0 ± 2.42.7 ± 3.1
SecondaryMean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months

Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

Time frame:
From baseline to 18 months
Reported as:
Mean · score on a scale
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Physical Function-1.20 ± 5.37-4.02 ± 7.81
Anxiety1.22 ± 10.943.04 ± 8.29
Depression1.39 ± 9.641.04 ± 5.21
Fatigue1.39 ± 9.516.04 ± 11.27
Sleep Disturbance3.55 ± 8.603.11 ± 10.39
Social Roles and Activities-1.94 ± 8.97-9.72 ± 13.05
Pain Interference4.95 ± 7.175.91 ± 8.98
Pain Intensity1.7 ± 2.21.4 ± 3.6
SecondaryMean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months

Patient Reported Outcomes Measurement Information System Adult Profile The PROMIS-29 is a 29-item profile instrument that covers 7 health domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and social function) with 4 questions each. The final item is an 11-point pain intensity numerical rating scale (NRS). Subjects should read each item and check the one box that most closely represents their response. Each item is scored on a scale from 1-5 with total scores for each domain ranging from 4-20. Greater scores represent more of whatever concept is being measured (e.g., depression or physical function). The scoring tables have been provided in the measure manual. Raw domain scores are converted to t-scores with a mean of 50 and a standard deviation of 10. The t-scores were validated on a sample from the general population and all items must be answered to utilize the scoring tables.

Time frame:
From baseline to 24 months
Reported as:
Mean · score on a scale
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Physical Function-2.75 ± 7.34-4.80 ± 8.47
Anxiety1.99 ± 11.533.50 ± 6.94
Depression0.69 ± 10.423.03 ± 5.28
Fatigue2.29 ± 11.552.90 ± 10.83
Sleep Disturbance3.57 ± 9.531.31 ± 8.37
Social Roles and Activities-3.09 ± 11.38-3.94 ± 8.49
Pain Interference7.15 ± 8.125.80 ± 8.22
Pain Intensity2.0 ± 2.52.4 ± 2.8
SecondaryMean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months

The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

Time frame:
From baseline to 3 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months15.8 ± 12.715.2 ± 13.3
SecondaryMean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months

The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

Time frame:
From baseline to 6 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months16.1 ± 12.414.6 ± 17.8
SecondaryMean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months

The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

Time frame:
From baseline to 12 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months17.0 ± 14.614.0 ± 17.6
SecondaryMean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months

The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

Time frame:
From baseline to 18 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months14.2 ± 13.816.2 ± 17.7
SecondaryMean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months

The PCS is a validated, 13-item scale that evaluates 3 domains of pain-related negative thoughts (rumination, magnification, and helplessness). Subjects rate how often they have the given thought from 0 "not at all" to 4 "all the time". The total score is a sum of all responses, ranging from 0-52. Each domain has a sub-scale score calculated as a sum of the constituent responses with ranges of 0-16 for rumination, 0-12 for magnification, and 0-24 for helplessness.

Time frame:
From baseline to 24 months
Reported as:
Mean · score on a scale
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months10.7 ± 11.819.6 ± 15.5
SecondaryMean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months

'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

Time frame:
From baseline to 3 months
Reported as:
Mean · score on a scale
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months34.5 ± 11.933.1 ± 13.4
SecondaryMean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months

'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

Time frame:
From baseline to 6 months
Reported as:
Mean · score on a scale
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months35.4 ± 11.934.7 ± 17.6
SecondaryMean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months

'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

Time frame:
From baseline to 12 months
Reported as:
Mean · score on a scale
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months36.0 ± 12.233.1 ± 14.3
SecondaryMean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months

'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

Time frame:
From baseline to 18 months
Reported as:
Mean · score on a scale
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months33.6 ± 12.330.5 ± 15.7
SecondaryMean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months

'The PVAQ is a validated, 16-item scale that evaluates attention to pain. Subjects rate how frequently each statement represents their experience over the last 2 weeks from 0 "never" to 5 "always". Item scores are summed to produce the total score, which ranges from 0-80 with a higher score indicating greater attention to pain.'

Time frame:
From baseline to 24 months
Reported as:
Mean · score on a scale
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months
score on a scaleSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months32.7 ± 14.435.0 ± 20.4
SecondaryChange in Pain Condition-related Medication Use From Baseline to 3 Months

Details will be collected regarding dosages and categories of pain-related medication.

Time frame:
From baseline to 3 months
Reported as:
Mean · Morphine milligram equivalent (MME)
Change in Pain Condition-related Medication Use From Baseline to 3 Months
Morphine milligram equivalent (MME)Subjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Change in Pain Condition-related Medication Use From Baseline to 3 Months9.9 ± 43.426.4 ± 59.0
SecondaryChange in Pain Condition-related Medication Use From Baseline to 6 Months

Details will be collected regarding dosages and categories of pain-related medication.

Time frame:
From baseline to 6 months
Reported as:
Mean · Morphine milligram equivalent (MME)
Change in Pain Condition-related Medication Use From Baseline to 6 Months
Morphine milligram equivalent (MME)Subjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Change in Pain Condition-related Medication Use From Baseline to 6 Months15.6 ± 51.533.0 ± 82.4
SecondaryChange in Pain Condition-related Medication Use From Baseline to 12 Months

Details will be collected regarding dosages and categories of pain-related medication.

Time frame:
From baseline to 12 months
Reported as:
Mean · Morphine milligram equivalent (MME)
Change in Pain Condition-related Medication Use From Baseline to 12 Months
Morphine milligram equivalent (MME)Subjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Change in Pain Condition-related Medication Use From Baseline to 12 Months16.4 ± 49.433.0 ± 82.4
SecondaryChange in Pain Condition-related Medication Use From Baseline to 18 Months

Details will be collected regarding dosages and categories of pain-related medication.

Time frame:
From baseline to 18 months
Reported as:
Mean · Morphine milligram equivalent (MME)
Change in Pain Condition-related Medication Use From Baseline to 18 Months
Morphine milligram equivalent (MME)Subjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Change in Pain Condition-related Medication Use From Baseline to 18 Months18.3 ± 56.658.9 ± 84.9
SecondaryChange in Pain Condition-related Medication Use From Baseline to 24 Months

Details will be collected regarding dosages and categories of pain-related medication.

Time frame:
From baseline to 24 months
Reported as:
Mean · Morphine milligram equivalent (MME)
Change in Pain Condition-related Medication Use From Baseline to 24 Months
Morphine milligram equivalent (MME)Subjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Change in Pain Condition-related Medication Use From Baseline to 24 Months15.4 ± 31.890.0 ± 127.3

Adverse events

Collected over 2 Year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects Using BurstDR SCS Systems3/85 (3.5%)1/85 (1.2%)11/85 (12.9%)
Subjects Using DRG Systems0/15 (0%)2/15 (13.3%)4/15 (26.7%)
Most frequent serious events
Most frequent serious events
EventSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Pain Below the Level of The ImplantSurgical and medical procedures0/851/15
Weakness, Clumsiness, or Numbness Below the Level of The ImplantSurgical and medical procedures0/851/15
Cerebrospinal Fluid (CSF) LeakageNervous system disorders1/850/15
NeuropraxiaNervous system disorders1/850/15
Most frequent other events
Showing 10 of 12
Most frequent other events
EventSubjects Using BurstDR SCS SystemsSubjects Using DRG Systems
Lead Migration, Causing Changes in Stimulation or Reduced Pain ReliefProduct Issues2/853/15
Lead FractureGeneral disorders1/852/15
Burning in FeetGeneral disorders0/851/15
High ImpedanceProduct Issues0/851/15
Battery FailureProduct Issues2/850/15
Persistent Pain at the IPG SiteInjury, poisoning and procedural complications2/850/15
Pain at Anchor SiteInjury, poisoning and procedural complications1/850/15
Post Procedural PainInjury, poisoning and procedural complications1/850/15
Sensation of HeatProduct Issues1/850/15
Shocking SensationProduct Issues1/850/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)Subjects Using BurstDR SCS SystemsSubjects Using DRG SystemsTotal
Mean62.6 ± 12.857.2 ± 18.761.8 ± 13.9
Sex: Female, Male
Sex: Female, Male(Participants)Subjects Using BurstDR SCS SystemsSubjects Using DRG SystemsTotal
Female47855
Male38745
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Subjects Using BurstDR SCS SystemsSubjects Using DRG SystemsTotal
Hispanic or Latino112
Not Hispanic or Latino761288
Unknown or Not Reported8210
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Subjects Using BurstDR SCS SystemsSubjects Using DRG SystemsTotal
American Indian or Alaska Native101
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American303
White771491
More than one race000
Unknown or Not Reported314
Region of Enrollment
Region of Enrollment(participants)Subjects Using BurstDR SCS SystemsSubjects Using DRG SystemsTotal
United States8515100
08

Study locations

21 sites
  • Spanish Hills Interventional Pain Specialists
    Camarillo, California 93010, United States
  • Coastal Pain & Spinal Diagnostics Medical Group
    Carlsbad, California 92009, United States
  • UC San Diego Center for Pain Medicine
    La Jolla, California 92037, United States
  • Napa Valley Orthopedic Medical Group
    Napa, California 94558, United States
  • Newport Beach Headache & Pain
    Newport Beach, California 92660, United States
  • Spine & Nerve Diagnostic Center
    Roseville, California 95661, United States
  • Pacific Research Institute
    San Francisco, California 94104, United States
  • Front Range Pain Medicine
    Fort Collins, Colorado 80528, United States
  • Boca Raton Regional Hospital
    Boca Raton, Florida 33486, United States
  • Pain Care, LLC
    Stockbridge, Georgia 30281, United States
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
  • Nura
    Edina, Minnesota 55435, United States
  • Nevada Advanced Pain Specialists
    Reno, Nevada 89511, United States
  • Garden State Pain Control
    Clifton, New Jersey 07013, United States
  • Albany Medical College at Albany Medical Center
    Albany, New York 12208, United States
  • Ainsworth Institute of Pain Management
    New York, New York 10022, United States
  • Northwest Brain & Spine
    Bend, Oregon 97701, United States
  • Center for Interventional Pain and Spine
    Lancaster, Pennsylvania 17604, United States
  • Allegheny General Hospital Department of Neurosurgery
    Pittsburgh, Pennsylvania 15212, United States
  • The Spine & Nerve Center of St. Francis Hospital
    Charleston, West Virginia 25301, United States
  • St. Mary's Hospital
    Huntington, West Virginia 25702, United States
09

References and documents

Study documents

  • Study protocol · Jan 23, 2019
  • Statistical analysis plan · Nov 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03908476
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Apr 9, 2019
Start date
Apr 16, 2019
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021
Results posted
Jan 25, 2023
Last update
Aug 1, 2023

Study contacts

Marie Fahey
study director · Abbott

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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