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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908476
Recruitment Status : Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date December 9, 2020
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Change in NRS from baseline to 3 months [ Time Frame: Baseline, 3-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
  • Change in NRS from baseline to 6 months [Time Frame: 6 months] [ Time Frame: Baseline, 6-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
  • Change in NRS from baseline to 12 months [Time Frame: 12 months] [ Time Frame: Baseline, 12-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
  • Change in NRS from baseline to 18 months [ Time Frame: Baseline, 18-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
  • Change in NRS from baseline to 24 months [ Time Frame: Baseline, 24-months ]
    A scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.'
  • 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.'
  • 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.'
  • 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.'
  • 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.'
  • Mean change in Patient Reported Pain Relief [ Time Frame: From baseline to end of trial, approximately 3-5 days ]
    A report of pain relief from 0% to 100%.
  • Change in pain condition-related medication use from baseline to 3 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From baseline to 24 months ]
    Details will be collected regarding dosages and categories of pain-related medication.
  • Number of participants with Therapy-related satisfaction from baseline to 3 months [ Time Frame: From baseline to 3 months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
  • Number of participants with Therapy-related satisfaction from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
  • Number of participants with Therapy-related satisfaction from baseline to 12 months [ Time Frame: From baseline to 12 months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
  • Number of participants with Therapy-related satisfaction from baseline to 18 months [ Time Frame: From baseline to 18 months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
  • Number of participants with Therapy-related satisfaction from baseline to 24 months [ Time Frame: From baseline to 24 months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
  • Number of participants with Therapy-related satisfaction from baseline to End of Trial [ Time Frame: From baseline to end of trial, approximately 3-5 days ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • PROMIS-29 [ Time Frame: Baseline, 3, 6, 12, 18, and 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.
  • Pain Catastrophizing Scale (PCS) [ Time Frame: Baseline, 3, 6, 12, 18, and 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.
  • Pain Vigilance and Awareness Questionnaire (PVAQ) [ Time Frame: Baseline, 3, 6, 12, 18, and 24-months ]
    A measure of attention and awareness of pain.
  • Patient Reported Pain Relief [ Time Frame: Up to 1 month ]
    A report of pain relief from 0% to 100%.
  • Pain condition-related medication use [ Time Frame: Baseline, 3, 6, 12, 18, and 24-months ]
    Details will be collected regarding dosages and categories of pain-related medication.
  • Therapy-related satisfaction [ Time Frame: Baseline, 3, 6, 12, 18, and 24-months ]
    Patient and Physician Satisfaction. The subject level of satisfaction about the pain relief provided by the therapy, their physical function and the ease of using the device will be assessed using the Likert scale. Additionally, physicians will be asked to assess their satisfaction about the therapy, the physical and mental health of the subject, and the ease of using the device. the Likert scale will be used for this assessment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROLONG Prospective, Multi-center, Open-label, Post-market Study
Official Title  ICMJE PROLONG Prospective, Multi-center, Open-label, Post-market Study
Brief Summary Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Detailed Description

This study will examine the utility of Abbott neurostimulation devices for restoring therapeutic benefit from neuromodulation therapy. These devices include programming the BurstDR waveform in an enabled implantable pulse generator (IPG), and dorsal root ganglion stimulation (Proclaim DRG). The BurstDR waveform offers a unique mechanism of action that may explain why it can restore efficacy where tonic stimulation has failed. While all forms of SCS activate the lateral pain pathway, which is responsible for the sensory aspects of pain, only BurstDR has been shown to activate the medial pain pathway which is responsible for the affective components. It is this medial activation that may allow BurstDR to succeed despite psychological factors such as catastrophizing and depression. Additionally, it is possible that BurstDR may be less susceptible to habituation because it more closely mimics natural thalamic firing.

Several different methods of implementing BurstDR may be included in this investigation to account for a range of possible existing systems and patient needs. It can be implemented by reprogramming a BurstDR-capable device, connecting a BurstDR-capable IPG to existing leads with an adapter or compatible header, or through full system replacement.

While traditional SCS applies stimulation to the dorsal horn of the spinal cord, DRG stimulation targets a bundle of sensory nerve cell bodies just outside of the spinal cord known as the dorsal root ganglion. This form of stimulation has been shown to make it easier to achieve pain-paresthesia overlap, provide consistent stimulation irrespective of body position, and produce paresthesia with a lower current than traditional SCS. Using DRG stimulation as a replacement or supplement to SCS may ensure reliable coverage of the entire painful area and improve pain outcomes.

This is the first prospective investigation designed to evaluate the effectiveness of Abbott neurostimulation devices for restoring pain relief in patients with waning or failed therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Device: Burst-capable SCS system
    Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
  • Device: DRG Stimulator
    Subjects will be implanted with a market-released Abbott DRG stimulation system.
Study Arms  ICMJE
  • Experimental: Subjects using BurstDR SCS systems
    Spinal cord stimulation with a Burst waveform.
    Intervention: Device: Burst-capable SCS system
  • Experimental: Subjects using DRG systems
    Dorsal root ganglion stimulation.
    Intervention: Device: DRG Stimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03908476
Other Study ID Numbers  ICMJE ABT-CIP-10277
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robyn Capobianco Abbott
PRS Account Abbott Medical Devices
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP