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

Chronic Pain Clinical Trial

— PROLONG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908476
• Other study ID #: ABT-CIP-10277
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Albany Medical College at Albany Medical Center	Albany	New York
United States	Northwest Brain & Spine	Bend	Oregon
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Spanish Hills Interventional Pain Specialists	Camarillo	California
United States	Coastal Pain & Spinal Diagnostics Medical Group	Carlsbad	California
United States	The Spine & Nerve Center of St. Francis Hospital	Charleston	West Virginia
United States	Garden State Pain Control	Clifton	New Jersey
United States	Nura	Edina	Minnesota
United States	Front Range Pain Medicine	Fort Collins	Colorado
United States	St. Mary's Hospital	Huntington	West Virginia
United States	UC San Diego Center for Pain Medicine	La Jolla	California
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	Napa Valley Orthopedic Medical Group	Napa	California
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Newport Beach Headache & Pain	Newport Beach	California
United States	Allegheny General Hospital Department of Neurosurgery	Pittsburgh	Pennsylvania
United States	Nevada Advanced Pain Specialists	Reno	Nevada
United States	Spine & Nerve Diagnostic Center	Roseville	California
United States	Pacific Research Institute	San Francisco	California
United States	Pain Care, LLC	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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