Trial Outcomes & Findings for CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies (NCT NCT02986074)

Results Overview

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

after 2 weeks of SCS trial

Results posted on

2021-05-03

Participant Flow

60 patients were enrolled and screened for eligibility between October 2016 and June 2018 in hospitals in London and Leeds U.K.

55 of 60 subjects were randomized. Of those not randomized 3 did not meet inclusion criteria, 1 withdrew consent and 1 was withdrawn by the investigator because his diabetes become uncontrolled increasing the risk associated with SCS implant

Participant milestones

Participant milestones
Measure	Anatomical Positioning Lead First subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead Anatomical midline lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial	Paresthesia Mapping Lead First subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead Paresthesia mapping lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial	Follow up Using Paresthesia Mapping Lead Stimulation Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach	Follow up Using Anatomical Placement Lead Stimulation Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach
First Trial Period STARTED	26	29	0	0
First Trial Period COMPLETED	25	29	0	0
First Trial Period NOT COMPLETED	1	0	0	0
Second Trial Period STARTED	25	29	0	0
Second Trial Period COMPLETED	25	29	0	0
Second Trial Period NOT COMPLETED	0	0	0	0
Follow up Period STARTED	0	0	21	22
Follow up Period 3 Month Follow up	0	0	21	21
Follow up Period 6 Month Follow up	0	0	21	20
Follow up Period COMPLETED	0	0	20	19
Follow up Period NOT COMPLETED	0	0	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Anatomical Positioning Lead First subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead Anatomical midline lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial	Follow up Using Paresthesia Mapping Lead Stimulation Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach	Follow up Using Anatomical Placement Lead Stimulation Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach
First Trial Period Adverse Event	1	0	0
Follow up Period system explant	0	1	2
Follow up Period Physician Decision	0	0	1

Baseline Characteristics

Gender was not reported for two subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=55 Participants All subjects who were enrolled in the study
Age, Continuous	51 years STANDARD_DEVIATION 12.1 • n=55 Participants
Sex: Female, Male Female	28 Participants n=53 Participants • Gender was not reported for two subjects
Sex: Female, Male Male	25 Participants n=53 Participants • Gender was not reported for two subjects
Region of Enrollment United Kingdom	55 participants n=55 Participants

PRIMARY outcome

Timeframe: after 2 weeks of SCS trial

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=54 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=54 Participants Stimulation delivered using the paresthesia mapping lead
Visual Analog Scale (VAS) for Back Pain at SCS Trial	32 units on a scale Standard Deviation 25.9	30.5 units on a scale Standard Deviation 25.4

SECONDARY outcome

Timeframe: 3 months after activation of permanent SCS implant

Population: one in the paresthesia mapping lead group had missing data

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=21 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
Visual Analog Scale (VAS) for Back Pain at 3 Months	28.5 units on a scale Standard Deviation 28.1	24.6 units on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: 6 months after activation of permanent SCS implant

Population: Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=19 Participants Stimulation delivered using the paresthesia mapping lead
Visual Analog Scale (VAS) for Back Pain at 6 Months	24 units on a scale Standard Deviation 24.5	35.2 units on a scale Standard Deviation 23.7

SECONDARY outcome

Timeframe: 12 months after activation of permanent SCS implant

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
Visual Analog Scale (VAS) for Back Pain at 12 Months	24 units on a scale Standard Deviation 24.5	31.8 units on a scale Standard Deviation 26.4

SECONDARY outcome

Timeframe: after 2 weeks of SCS trial

Population: Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=53 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=53 Participants Stimulation delivered using the paresthesia mapping lead
EQ-5D at SCS Trial	0.68 score on a scale Standard Deviation 0.17	0.65 score on a scale Standard Deviation 0.16

SECONDARY outcome

Timeframe: 3 months after activation of permanent SCS implant

Population: Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=20 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=19 Participants Stimulation delivered using the paresthesia mapping lead
EQ-5D at 3 Month	0.73 score on a scale Standard Deviation 0.2	0.63 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 6 months after activation of permanent SCS implant

Population: One patient had missing data in the anatomically positioned lead group

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=21 Participants Stimulation delivered using the paresthesia mapping lead
EQ-5D at 6 Month	0.62 score on a scale Standard Deviation 0.27	0.64 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 12 months after activation of permanent SCS implant

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
EQ-5D at 12 Month	0.69 score on a scale Standard Deviation 0.22	0.67 score on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: first SCS trial assessment (up to two weeks after electrodes implantation)

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=54 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=54 Participants Stimulation delivered using the paresthesia mapping lead
ODI at SCS Trial	40.2 score on a scale Standard Deviation 17.1	41.8 score on a scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: 3 months after activation of permanent SCS implant

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=21 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=21 Participants Stimulation delivered using the paresthesia mapping lead
ODI at 3 Months	33.8 score on a scale Standard Deviation 22.6	37.3 score on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: 6 months after activation of permanent SCS implant

Population: One patient had missing data in the anatomically positioned lead group

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=21 Participants Stimulation delivered using the paresthesia mapping lead
ODI at 6 Months	41.5 score on a scale Standard Deviation 23.5	36.9 score on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: 12 months after activation of permanent SCS implant

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=19 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
ODI at 12 Months	33.9 score on a scale Standard Deviation 21.5	39.4 score on a scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: 3 month follow up

Population: One patient had missing data in the paresthesia mapping lead group

questionnaire regarding patient satisfaction with the therapy

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=21 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
Satisfaction Questionnaire very dissatisfied	0 Participants	0 Participants
Satisfaction Questionnaire dissatisfied	0 Participants	0 Participants
Satisfaction Questionnaire neither satisfied or dissatisfied	4 Participants	1 Participants
Satisfaction Questionnaire satisfied	8 Participants	7 Participants
Satisfaction Questionnaire very satisfied	9 Participants	12 Participants

SECONDARY outcome

Timeframe: 6 month follow up

Population: four patients had missing data in the anatomically positioned lead group

questionnaire regarding patient satisfaction with the therapy

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=17 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=21 Participants Stimulation delivered using the paresthesia mapping lead
Satisfaction Questionnaire very dissatisfied	1 Participants	0 Participants
Satisfaction Questionnaire dissatisfied	1 Participants	2 Participants
Satisfaction Questionnaire neither satisfied nor dissatisfied	4 Participants	3 Participants
Satisfaction Questionnaire satisfied	4 Participants	5 Participants
Satisfaction Questionnaire very satisfied	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 12 month follow up

Population: One patient had missing data in the anatomically positioned lead group

questionnaire regarding patient satisfaction with the therapy

Outcome measures

Outcome measures
Measure	Anatomically Positioned Lead n=18 Participants Stimulation delivered using the anatomical lead	Paresthesia Mapping Lead n=20 Participants Stimulation delivered using the paresthesia mapping lead
Satisfaction Questionnaire satisfied	9 Participants	4 Participants
Satisfaction Questionnaire very satisfied	8 Participants	13 Participants
Satisfaction Questionnaire very dissatisfied	0 Participants	0 Participants
Satisfaction Questionnaire dissatisfied	1 Participants	1 Participants
Satisfaction Questionnaire neither satisfied nor dissatisfied	0 Participants	2 Participants

Adverse Events

Anatomically Positioned Leads and Parasthesia Mapped Leads

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anatomically Positioned Leads and Parasthesia Mapped Leads n=55 participants at risk All subjects enrolled in the study
Gastrointestinal disorders abdominal pain due to gall stones	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
General disorders difficulty urination and inability to weight bear on right leg	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
General disorders right leg numbness	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
General disorders worsening of pain	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
General disorders photophobia	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
Surgical and medical procedures wound exploration	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
Infections and infestations system explant due to suspicion of infection	1.8% 1/55 • Number of events 1 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.

Other adverse events

Other adverse events
Measure	Anatomically Positioned Leads and Parasthesia Mapped Leads n=55 participants at risk All subjects enrolled in the study
General disorders IPG pain	5.5% 3/55 • Number of events 4 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
General disorders headache	5.5% 3/55 • Number of events 3 • Through completion of the study, on average about 1 year Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.

Additional Information

Yagna Pathak

Abbott

Phone: +1-469-243-0088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place