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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Burst-capable SCS system; Device: DRG Stimulator

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects using BurstDR SCS systems; Spinal cord stimulation with a Burst waveform.	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.
Experimental: Subjects using DRG systems; Dorsal root ganglion stimulation.	Device: DRG Stimulator; Subjects will be implanted with a market-released Abbott DRG stimulation system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to 3 months
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.	From Baseline to 6 months
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.	From Baseline to 12 months
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.	From Baseline to 18 months
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.	From Baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 3 months
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.	From baseline to 6 months
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.	From baseline to 12 months
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.	From baseline to 18 months
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.	From baseline to 24 months
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.	From baseline to 3 months
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.	From baseline to 6 months
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.	From baseline to 12 months
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.	From baseline to 18 months
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.	From baseline to 24 months
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.'	From baseline to 3 months
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.'	From baseline to 6 months
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.'	From baseline to 12 months
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.'	From baseline to 18 months
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.'	From baseline to 24 months
Change in Pain Condition-related Medication Use From Baseline to 3 Months	Details will be collected regarding dosages and categories of pain-related medication.	From baseline to 3 months
Change in Pain Condition-related Medication Use From Baseline to 6 Months	Details will be collected regarding dosages and categories of pain-related medication.	From baseline to 6 months
Change in Pain Condition-related Medication Use From Baseline to 12 Months	Details will be collected regarding dosages and categories of pain-related medication.	From baseline to 12 months
Change in Pain Condition-related Medication Use From Baseline to 18 Months	Details will be collected regarding dosages and categories of pain-related medication.	From baseline to 18 months
Change in Pain Condition-related Medication Use From Baseline to 24 Months	Details will be collected regarding dosages and categories of pain-related medication.	From baseline to 24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Marie Fahey, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Spinal cord stimulation; SCS; DRG; ABT-CIP-10277; BurstDR
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ABT-CIP-10277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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