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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03908476

Acronym

PROLONG

Enrollment

118

Registered

2019-04-09

Start date

2019-04-16

Completion date

2021-11-15

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

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

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.

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months	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	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	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	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	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

Measure	Time frame	Description
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months	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	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	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	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	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	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	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 Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months	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 Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months	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	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.'
Change in Pain Condition-related Medication Use From Baseline to 3 Months	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	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	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	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	From baseline to 24 months	Details will be collected regarding dosages and categories of pain-related medication.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months	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 Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

100 subjects proceeded with a permanent implant

Participants by arm

Arm	Count
Subjects Using BurstDR SCS Systems Spinal cord stimulation with a Burst waveform. 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.	85
Subjects Using DRG Systems Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.	15
Total	100

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	3	0
Overall Study	Intrathecal Pump	1	0
Overall Study	Lost to Follow-up	3	1
Overall Study	Patient Has Requested an Explant of the Device	1	0
Overall Study	Physician Decision	2	0
Overall Study	System Explanted and not Replaced	4	0
Overall Study	Withdrawal by Subject	7	1

Baseline characteristics

Characteristic	Subjects Using BurstDR SCS Systems	Total	Subjects Using DRG Systems
Age, Continuous	62.6 years STANDARD_DEVIATION 12.8	61.8 years STANDARD_DEVIATION 13.9	57.2 years STANDARD_DEVIATION 18.7
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants	88 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants	10 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	4 Participants	1 Participants
Race (NIH/OMB) White	77 Participants	91 Participants	14 Participants
Region of Enrollment United States	85 participants	100 participants	15 participants
Sex: Female, Male Female	47 Participants	55 Participants	8 Participants
Sex: Female, Male Male	38 Participants	45 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	3 / 85	0 / 15
other Total, other adverse events	11 / 85	4 / 15
serious Total, serious adverse events	1 / 85	2 / 15

Outcome results

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.

Time frame: From Baseline to 12 months