Trial Outcomes & Findings for PROLONG Prospective, Multi-center, Open-label, Post-market Study (NCT NCT03908476)

NCT ID: NCT03908476

Last Updated: 2023-08-01

Results Overview

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 118 participants
• Primary outcome timeframe: From Baseline to 3 months
• Results posted on: 2023-08-01

Participant Flow

100 subjects proceeded with a permanent implant

Participant milestones

Measure	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.	Subjects Using DRG Systems Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Overall Study STARTED	85	15
Overall Study COMPLETED	64	13
Overall Study NOT COMPLETED	21	2

Reasons for withdrawal

Measure	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.	Subjects Using DRG Systems Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Overall Study Death	3	0
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	7	1
Overall Study Physician Decision	2	0
Overall Study System Explanted and not Replaced	4	0
Overall Study Intrathecal Pump	1	0
Overall Study Patient Has Requested an Explant of the Device	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.	Total n=100 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	57.2 years STANDARD_DEVIATION 18.7 • n=7 Participants	61.8 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	8 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	7 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	12 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	14 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	15 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=74 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 3 Months	2.3 score on a scale Standard Deviation 2.5	3.3 score on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: From Baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=67 Participants 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.	Subjects Using DRG Systems n=14 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 6 Months	2.5 score on a scale Standard Deviation 2.7	3.1 score on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: From Baseline to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=66 Participants 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.	Subjects Using DRG Systems n=13 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 12 Months	2.5 score on a scale Standard Deviation 2.6	2.6 score on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: From Baseline to 18 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=45 Participants 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.	Subjects Using DRG Systems n=11 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 18 Months	2.2 score on a scale Standard Deviation 2.5	1.5 score on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: From Baseline to 24 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Numerical Rating Scale (NRS) is a scale which measures pain intensity from 0-10, with 0 being no pain and 10 being worst pain.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=23 Participants 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.	Subjects Using DRG Systems n=7 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Numerical Rating Scale (NRS) From Baseline to 24 Months	2.8 score on a scale Standard Deviation 2.6	2.0 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Physical Function	-2.72 score on a scale Standard Deviation 5.63	-4.90 score on a scale Standard Deviation 7.93
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Anxiety	2.36 score on a scale Standard Deviation 8.81	1.05 score on a scale Standard Deviation 7.18
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Depression	3.02 score on a scale Standard Deviation 9.47	2.43 score on a scale Standard Deviation 9.12
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Fatigue	3.03 score on a scale Standard Deviation 9.91	7.51 score on a scale Standard Deviation 6.87
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Sleep Disturbance	4.08 score on a scale Standard Deviation 8.00	2.99 score on a scale Standard Deviation 10.91
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Social Roles and Activities	-3.25 score on a scale Standard Deviation 8.36	-4.54 score on a scale Standard Deviation 11.52
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Pain Interference	5.00 score on a scale Standard Deviation 7.87	5.56 score on a scale Standard Deviation 9.25
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 3 Months Pain Intensity	1.9 score on a scale Standard Deviation 2.4	2.9 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Physical Function	-2.21 score on a scale Standard Deviation 5.28	-5.30 score on a scale Standard Deviation 8.64
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Anxiety	2.99 score on a scale Standard Deviation 7.64	-0.96 score on a scale Standard Deviation 11.25
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Depression	2.52 score on a scale Standard Deviation 8.74	-1.78 score on a scale Standard Deviation 9.83
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Fatigue	3.03 score on a scale Standard Deviation 9.55	4.81 score on a scale Standard Deviation 12.37
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Sleep Disturbance	4.73 score on a scale Standard Deviation 9.59	4.23 score on a scale Standard Deviation 13.32
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Social Roles and Activities	-2.76 score on a scale Standard Deviation 8.04	-4.49 score on a scale Standard Deviation 11.29
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Pain Interference	5.32 score on a scale Standard Deviation 7.44	6.59 score on a scale Standard Deviation 9.54
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 6 Months Pain Intensity	2.2 score on a scale Standard Deviation 2.4	3.0 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Physical Function	-2.28 score on a scale Standard Deviation 5.74	-5.97 score on a scale Standard Deviation 8.01
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Anxiety	1.96 score on a scale Standard Deviation 9.86	2.68 score on a scale Standard Deviation 12.71
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Depression	1.05 score on a scale Standard Deviation 10.14	0.30 score on a scale Standard Deviation 11.43
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Fatigue	3.38 score on a scale Standard Deviation 8.72	4.19 score on a scale Standard Deviation 10.76
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Sleep Disturbance	3.44 score on a scale Standard Deviation 8.83	2.81 score on a scale Standard Deviation 12.24
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Social Roles and Activities	-2.13 score on a scale Standard Deviation 8.36	-4.99 score on a scale Standard Deviation 11.01
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Pain Interference	4.68 score on a scale Standard Deviation 7.94	6.46 score on a scale Standard Deviation 11.16
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 12 Months Pain Intensity	2.0 score on a scale Standard Deviation 2.4	2.7 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: From baseline to 18 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Physical Function	-1.20 score on a scale Standard Deviation 5.37	-4.02 score on a scale Standard Deviation 7.81
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Anxiety	1.22 score on a scale Standard Deviation 10.94	3.04 score on a scale Standard Deviation 8.29
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Depression	1.39 score on a scale Standard Deviation 9.64	1.04 score on a scale Standard Deviation 5.21
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Fatigue	1.39 score on a scale Standard Deviation 9.51	6.04 score on a scale Standard Deviation 11.27
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Sleep Disturbance	3.55 score on a scale Standard Deviation 8.60	3.11 score on a scale Standard Deviation 10.39
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Social Roles and Activities	-1.94 score on a scale Standard Deviation 8.97	-9.72 score on a scale Standard Deviation 13.05
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Pain Interference	4.95 score on a scale Standard Deviation 7.17	5.91 score on a scale Standard Deviation 8.98
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 18 Months Pain Intensity	1.7 score on a scale Standard Deviation 2.2	1.4 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Physical Function	-2.75 score on a scale Standard Deviation 7.34	-4.80 score on a scale Standard Deviation 8.47
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Anxiety	1.99 score on a scale Standard Deviation 11.53	3.50 score on a scale Standard Deviation 6.94
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Depression	0.69 score on a scale Standard Deviation 10.42	3.03 score on a scale Standard Deviation 5.28
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Fatigue	2.29 score on a scale Standard Deviation 11.55	2.90 score on a scale Standard Deviation 10.83
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Sleep Disturbance	3.57 score on a scale Standard Deviation 9.53	1.31 score on a scale Standard Deviation 8.37
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Social Roles and Activities	-3.09 score on a scale Standard Deviation 11.38	-3.94 score on a scale Standard Deviation 8.49
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Pain Interference	7.15 score on a scale Standard Deviation 8.12	5.80 score on a scale Standard Deviation 8.22
Mean Change in Health Domains Assessed by PROMIS-29 Scale From Baseline to 24 Months Pain Intensity	2.0 score on a scale Standard Deviation 2.5	2.4 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=73 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 3 Months	15.8 score on a scale Standard Deviation 12.7	15.2 score on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=67 Participants 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.	Subjects Using DRG Systems n=14 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 6 Months	16.1 score on a scale Standard Deviation 12.4	14.6 score on a scale Standard Deviation 17.8

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=66 Participants 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.	Subjects Using DRG Systems n=13 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 12 Months	17.0 score on a scale Standard Deviation 14.6	14.0 score on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: From baseline to 18 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=45 Participants 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.	Subjects Using DRG Systems n=11 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 18 Months	14.2 score on a scale Standard Deviation 13.8	16.2 score on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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.

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=23 Participants 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.	Subjects Using DRG Systems n=7 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Pain Assessed by Pain Catastrophizing Scale (PCS) From Baseline to 24 Months	10.7 score on a scale Standard Deviation 11.8	19.6 score on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

'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.'

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=74 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 3 Months	34.5 score on a scale Standard Deviation 11.9	33.1 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

'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.'

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=67 Participants 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.	Subjects Using DRG Systems n=14 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 6 Months	35.4 score on a scale Standard Deviation 11.9	34.7 score on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

'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.'

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=66 Participants 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.	Subjects Using DRG Systems n=13 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 12 Months	36.0 score on a scale Standard Deviation 12.2	33.1 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: From baseline to 18 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

'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.'

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=45 Participants 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.	Subjects Using DRG Systems n=11 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 18 Months	33.6 score on a scale Standard Deviation 12.3	30.5 score on a scale Standard Deviation 15.7

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

'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.'

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=23 Participants 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.	Subjects Using DRG Systems n=7 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Mean Change in Attention to Pain Assessed by Pain Vigilance and Awareness Questionnaire (PVAQ) From Baseline to 24 Months	32.7 score on a scale Standard Deviation 14.4	35.0 score on a scale Standard Deviation 20.4

SECONDARY outcome

Timeframe: From baseline to 3 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=44 Participants 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.	Subjects Using DRG Systems n=5 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Change in Pain Condition-related Medication Use From Baseline to 3 Months	9.9 Morphine milligram equivalent (MME) Standard Deviation 43.4	26.4 Morphine milligram equivalent (MME) Standard Deviation 59.0

SECONDARY outcome

Timeframe: From baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=39 Participants 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.	Subjects Using DRG Systems n=5 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Change in Pain Condition-related Medication Use From Baseline to 6 Months	15.6 Morphine milligram equivalent (MME) Standard Deviation 51.5	33.0 Morphine milligram equivalent (MME) Standard Deviation 82.4

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=38 Participants 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.	Subjects Using DRG Systems n=5 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Change in Pain Condition-related Medication Use From Baseline to 12 Months	16.4 Morphine milligram equivalent (MME) Standard Deviation 49.4	33.0 Morphine milligram equivalent (MME) Standard Deviation 82.4

SECONDARY outcome

Timeframe: From baseline to 18 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Change in Pain Condition-related Medication Use From Baseline to 18 Months	18.3 Morphine milligram equivalent (MME) Standard Deviation 56.6	58.9 Morphine milligram equivalent (MME) Standard Deviation 84.9

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: The number of participants analyzed includes subjects who were available at that time of analysis

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

Outcome measures

Measure	Subjects Using BurstDR SCS Systems n=85 Participants 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.	Subjects Using DRG Systems n=15 Participants Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Change in Pain Condition-related Medication Use From Baseline to 24 Months	15.4 Morphine milligram equivalent (MME) Standard Deviation 31.8	90.0 Morphine milligram equivalent (MME) Standard Deviation 127.3

Adverse Events

Subjects Using BurstDR SCS Systems

Serious events: 1 serious events

Other events: 11 other events

Deaths: 3 deaths

Subjects Using DRG Systems

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects Using BurstDR SCS Systems n=85 participants at risk 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.	Subjects Using DRG Systems n=15 participants at risk Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Nervous system disorders Cerebrospinal Fluid (CSF) Leakage	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Nervous system disorders Neuropraxia	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Surgical and medical procedures Pain Below the Level of The Implant	0.00% 0/85 • 2 Year	6.7% 1/15 • 2 Year
Surgical and medical procedures Weakness, Clumsiness, or Numbness Below the Level of The Implant	0.00% 0/85 • 2 Year	6.7% 1/15 • 2 Year

Other adverse events

Measure	Subjects Using BurstDR SCS Systems n=85 participants at risk 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.	Subjects Using DRG Systems n=15 participants at risk Dorsal root ganglion stimulation. DRG Stimulator: Subjects will be implanted with a market-released Abbott DRG stimulation system.
Product Issues Battery Failure	2.4% 2/85 • 2 Year	0.00% 0/15 • 2 Year
Injury, poisoning and procedural complications Persistent Pain at the IPG Site	2.4% 2/85 • 2 Year	0.00% 0/15 • 2 Year
General disorders Lead Fracture	1.2% 1/85 • 2 Year	13.3% 2/15 • 2 Year
Injury, poisoning and procedural complications Pain at Anchor Site	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Injury, poisoning and procedural complications Post Procedural Pain	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Product Issues Sensation of Heat	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Product Issues Shocking Sensation	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Product Issues Skin Erosion at the IPG Site	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
General disorders Thoracic Pain	1.2% 1/85 • 2 Year	0.00% 0/15 • 2 Year
Product Issues Lead Migration, Causing Changes in Stimulation or Reduced Pain Relief	2.4% 2/85 • 2 Year	20.0% 3/15 • 2 Year
General disorders Burning in Feet	0.00% 0/85 • 2 Year	6.7% 1/15 • 2 Year
Product Issues High Impedance	0.00% 0/85 • 2 Year	6.7% 1/15 • 2 Year

Additional Information

Marie Fahey

Abbott

Phone: +15122864398

Email: Marie.fahey@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place