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Completed

NCT Number: NCT03908476

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spanish Hills Interventional Pain Specialists, Camarillo, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Burst-capable SCS system

Device

Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.

DRG Stimulator

Device

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.'

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

    Time frame: 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.'

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

    Time frame: 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.'

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

    Time frame: 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.'

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

    Time frame: 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.'

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

    Time frame: From baseline to 3 months

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

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

    Time frame: From baseline to 6 months

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

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

    Time frame: From baseline to 12 months

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

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

    Time frame: From baseline to 18 months

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

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

    Time frame: From baseline to 24 months

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: PROLONG

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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