Trial Outcomes & Findings for Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System (NCT NCT01847885)

Last Updated: 2017-10-16

Results Overview

A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Baseline, End of Treatment (4-weeks of Treatment/Control)

Results posted on

2017-10-16

Participant Flow

Recruitment began in March 2013 and was concluded in May 2015. Subjects were screened for the study from the available pool of candidates who presented to the Investigators with shoulder pain following stroke.

Following informed consent and enrollment in the study, subjects were given a 7-day diary to complete at home. At the following visit, subjects were randomized once all eligibility criteria were met. Therefore it was possible for subjects to no longer meet eligibility criteria or drop out after enrollment, but prior to being randomized.

Participant milestones

Participant milestones
Measure	Enrolled Subjects Subjects who signed a consent form.	Smartpatch Treatment Group (Full Analysis Set) Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Initial Enrollment (Consented) STARTED	88	0	0
Initial Enrollment (Consented) Randomized	46	0	0
Initial Enrollment (Consented) Full Analysis Set	43	0	0
Initial Enrollment (Consented) Safety Set	41	0	0
Initial Enrollment (Consented) Per Protocol Set	40	0	0
Initial Enrollment (Consented) COMPLETED	40	0	0
Initial Enrollment (Consented) NOT COMPLETED	48	0	0
Randomization STARTED	0	31	15
Randomization Full Analysis Set	0	28	15
Randomization Safety Set	0	28	13
Randomization Per Protocol Set	0	27	13
Randomization COMPLETED	0	27	13
Randomization NOT COMPLETED	0	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled Subjects Subjects who signed a consent form.	Smartpatch Treatment Group (Full Analysis Set) Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Initial Enrollment (Consented) Protocol Violation	1	0	0
Initial Enrollment (Consented) Withdrawal by Subject	2	0	0
Initial Enrollment (Consented) Screen failure	39	0	0
Initial Enrollment (Consented) Pending prior to enrollment stop	6	0	0
Randomization Protocol Violation	0	1	0
Randomization Withdrawal by Subject	0	0	2
Randomization Screen Failure	0	3	0

Baseline Characteristics

Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=15 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.	Total n=43 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 11.8 • n=28 Participants	58.9 years STANDARD_DEVIATION 9.8 • n=15 Participants	57.8 years STANDARD_DEVIATION 11.1 • n=43 Participants
Sex: Female, Male Female	10 Participants n=28 Participants	6 Participants n=15 Participants	16 Participants n=43 Participants
Sex: Female, Male Male	18 Participants n=28 Participants	9 Participants n=15 Participants	27 Participants n=43 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=28 Participants	0 Participants n=15 Participants	3 Participants n=43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=28 Participants	15 Participants n=15 Participants	40 Participants n=43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants	0 Participants n=15 Participants	0 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants	0 Participants n=15 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Asian	2 Participants n=28 Participants	3 Participants n=15 Participants	5 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants	0 Participants n=15 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Black or African American	10 Participants n=28 Participants	1 Participants n=15 Participants	11 Participants n=43 Participants
Race (NIH/OMB) White	15 Participants n=28 Participants	11 Participants n=15 Participants	26 Participants n=43 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants	0 Participants n=15 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=28 Participants	0 Participants n=15 Participants	1 Participants n=43 Participants
Type of stroke Hemorrhagic	11 Participants n=28 Participants	5 Participants n=15 Participants	16 Participants n=43 Participants
Type of stroke Ischemic	16 Participants n=28 Participants	10 Participants n=15 Participants	26 Participants n=43 Participants
Type of stroke Unknown/not collected	1 Participants n=28 Participants	0 Participants n=15 Participants	1 Participants n=43 Participants
Time elapsed from stroke, years	5.1 years STANDARD_DEVIATION 4.7 • n=28 Participants	3.5 years STANDARD_DEVIATION 2.8 • n=15 Participants	4.5 years STANDARD_DEVIATION 4.2 • n=43 Participants
Presence of shoulder subluxation Subluxation present	23 Participants n=28 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).	11 Participants n=13 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).	34 Participants n=41 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).
Presence of shoulder subluxation Subluxation absent	5 Participants n=28 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).	2 Participants n=13 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).	7 Participants n=41 Participants • Subjects were evaluated to determine the presence or absence of shoulder subluxation (partial or incomplete dislocation of shoulder). Of note, this analysis is on the safety set (subjects who received a Smartpatch lead where n=41).
Beck Depression Inventory score	13.2 Beck Depression Score STANDARD_DEVIATION 9.0 • n=28 Participants	17.6 Beck Depression Score STANDARD_DEVIATION 11.9 • n=15 Participants	14.7 Beck Depression Score STANDARD_DEVIATION 10.1 • n=43 Participants

PRIMARY outcome

Timeframe: Baseline, End of Treatment (4-weeks of Treatment/Control)

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=15 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) Baseline diary score	7.1 scores on a scale Standard Deviation 1.5	6.6 scores on a scale Standard Deviation 1.5
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) EOT diary score	4.1 scores on a scale Standard Deviation 2.3	4.1 scores on a scale Standard Deviation 3.1
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) Change in pain intensity from baseline	3.1 scores on a scale Standard Deviation 2.3	2.5 scores on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment

Population: Safety set

At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups	16 device related adverse events	3 device related adverse events

SECONDARY outcome

Timeframe: Baseline, End of Treatment (4-weeks of Treatment/Control)

Population: Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment).

The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Change From Baseline Shoulder Pain Interference at End of Treatment Baseline score	4.8 scores on a scale Standard Deviation 2.4	5.0 scores on a scale Standard Deviation 2.0
Change From Baseline Shoulder Pain Interference at End of Treatment EOT score	1.8 scores on a scale Standard Deviation 1.8	2.6 scores on a scale Standard Deviation 3.3
Change From Baseline Shoulder Pain Interference at End of Treatment Change in pain interference from baseline	3.1 scores on a scale Standard Deviation 2.2	2.4 scores on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, 12-wks post-treatment

Population: Full analysis set

A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=15 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment Baseline diary score	7.1 scores on a scale Standard Deviation 1.5	6.6 scores on a scale Standard Deviation 1.5
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment 12- weeks post-treatment diary score	4.3 scores on a scale Standard Deviation 2.9	4.3 scores on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, End of Treatment (4-weeks of Treatment/Control)

The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject's health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Change From Baseline Quality of Life at End of Treatment Physical Component Baseline score	38.0 scores on a scale Standard Deviation 8.9	35.4 scores on a scale Standard Deviation 10.4
Change From Baseline Quality of Life at End of Treatment Change in Physical Component score from baseline	4.8 scores on a scale Standard Deviation 7.0	3.5 scores on a scale Standard Deviation 9.3
Change From Baseline Quality of Life at End of Treatment Mental Component Baseline score	54.3 scores on a scale Standard Deviation 10.7	47.9 scores on a scale Standard Deviation 9.5
Change From Baseline Quality of Life at End of Treatment Change in Mental Component score from baseline	4.1 scores on a scale Standard Deviation 10.1	9.1 scores on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline, End of Treatment (4-weeks of Treatment/Control)

A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as "please rate your pain by circling the one number that best describes your pain on the average". BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Change From Baseline Average Pain Intensity at End of Treatment Baseline diary score	5.2 scores on a scale Standard Deviation 2.0	4.8 scores on a scale Standard Deviation 1.7
Change From Baseline Average Pain Intensity at End of Treatment EOT diary score	2.6 scores on a scale Standard Deviation 1.8	2.4 scores on a scale Standard Deviation 2.2
Change From Baseline Average Pain Intensity at End of Treatment Change in pain intensity from baseline	2.7 scores on a scale Standard Deviation 2.3	2.5 scores on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: End of Treatment (4-weeks of Treatment/Control)

The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Patient Global Impression of Change at End of Treatment Very much worse	0 Participants	0 Participants
Patient Global Impression of Change at End of Treatment Much worse	0 Participants	0 Participants
Patient Global Impression of Change at End of Treatment Minimally worse	0 Participants	2 Participants
Patient Global Impression of Change at End of Treatment No change	1 Participants	2 Participants
Patient Global Impression of Change at End of Treatment Minimally improved	11 Participants	5 Participants
Patient Global Impression of Change at End of Treatment Much improved	13 Participants	3 Participants
Patient Global Impression of Change at End of Treatment Very much improved	2 Participants	1 Participants

SECONDARY outcome

Timeframe: End of Treatment (4-weeks of Treatment/Control)

Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as "no change" (no change in dosage or change is not clinically meaningful to impact pain outcomes), "increase" (clinically meaningful increase in medication that would impact pain outcomes), or "decrease" (clinically meaningful decrease in medication that would impact pain outcomes).

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=25 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Change in Pain Medication Usage at End of Treatment Decrease in pain med usage compared to baseline	6 Participants	4 Participants
Change in Pain Medication Usage at End of Treatment No change in pain med usage compared to baseline	16 Participants	8 Participants
Change in Pain Medication Usage at End of Treatment Increase in pain med usage compared to baseline	3 Participants	1 Participants

SECONDARY outcome

Timeframe: End of Treatment (4-weeks of Treatment/Control)

The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject's total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved".

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=26 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Clinical Global Impression of Improvement at End of Treatment Very much worse	0 Participants	0 Participants
Clinical Global Impression of Improvement at End of Treatment Much worse	0 Participants	0 Participants
Clinical Global Impression of Improvement at End of Treatment Minimally worse	0 Participants	1 Participants
Clinical Global Impression of Improvement at End of Treatment No change	1 Participants	3 Participants
Clinical Global Impression of Improvement at End of Treatment Minimally improved	11 Participants	4 Participants
Clinical Global Impression of Improvement at End of Treatment Much improved	10 Participants	5 Participants
Clinical Global Impression of Improvement at End of Treatment Very much improved	4 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: End of Treatment (4-weeks of Treatment/Control)

Population: Safety set (Subjects who were implanted with a Smartpatch Lead)

Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
User Satisfaction With The Smartpatch System at End of Treatment Reported study had positive impact on their life	27 Participants	9 Participants
User Satisfaction With The Smartpatch System at End of Treatment Reported being satisfied with experience in study	27 Participants	10 Participants
User Satisfaction With The Smartpatch System at End of Treatment Would recommend participation in study to a friend	28 Participants	11 Participants
User Satisfaction With The Smartpatch System at End of Treatment Tolerated lead placement with no discomfort	16 Participants	8 Participants
User Satisfaction With The Smartpatch System at End of Treatment Tolerated lead placement with some discomfort	11 Participants	5 Participants
User Satisfaction With The Smartpatch System at End of Treatment Tolerated lead placement with a lot of discomfort	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-week post-treatment

Population: Safety set (Subjects who were implanted with a Smartpatch Lead)

Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=28 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Reported study had positive impact on their life	27 Participants	11 Participants
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Reported being satisfied with experience in study	26 Participants	11 Participants
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Would recommend participation in study to a friend	28 Participants	13 Participants
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Tolerated lead placement with no discomfort	20 Participants	9 Participants
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Tolerated lead placement with some discomfort	7 Participants	4 Participants
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment Tolerated lead placement with a lot of discomfort	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At completion of study, approximately 2.5 years

Population: "Count of participants" represents Investigators responding to the survey rather than study participants.

A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=7 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Performance of the Smartpatch System Agreed time to perform procedure was acceptable	7 Participants	—
Performance of the Smartpatch System Agreed that device components performed well	6 Participants	—
Performance of the Smartpatch System Agreed that patients tolerated the procedure well	6 Participants	—
Performance of the Smartpatch System Agreed that the Smartpatch System was easy to use	7 Participants	—
Performance of the Smartpatch System Liked the size, weight, & shape of the Stimulator	7 Participants	—
Performance of the Smartpatch System Agreed study beneficial for most of their patients	5 Participants	—

POST_HOC outcome

Timeframe: 4 weeks (from baseline visit to EOT visit)

Subjects who reported an reduction of at least 30% in either pain intensity or pain interference from baseline to End of Treatment (EOT) using the Brief Pain Inventory (BPI) Short Form. The pain intensity score is excerpted from BPI question 3, worst pain, taken from 7-day diaries. This scale ranges from 0 representing no pain to 10 representing worst pain. The median diary score at EOT was compared to the median baseline diary score to calculate the percentage of subjects who had at least a 30% reduction in pain intensity. Pain interference was assessed using BPI question 9. Subjects rated the degree to which their pain interfered with seven facets of daily life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes". The mean of these 7 scores was calculated to obtain the pain interference score. The score at EOT was compared to the baseline score to determine the percentage of subjects who had at least a 30% reduction in pain interference.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)	25 Participants	8 Participants

POST_HOC outcome

Timeframe: 4 weeks (from baseline visit to EOT visit)

The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores was calculated to obtain the pain interference score. The score at End of Treatment (EOT) was compared to the baseline score to determine the percentage of subjects who had a clinically significant (30% or greater) reduction in pain interference.

Outcome measures

Outcome measures
Measure	Smartpatch Treatment Group (Full Analysis Set) n=27 Participants Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Full Analysis Set) n=13 Participants Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)	24 Participants	7 Participants

Adverse Events

Enrolled Subjects Who Did Not Receive the Study Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Smartpatch Treatment Group (Safety Set)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Smartpatch Control Group (Safety Set)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled Subjects Who Did Not Receive the Study Device n=88 participants at risk Subjects who were consented, but were not randomized and did not receive the study device or any intervention.	Smartpatch Treatment Group (Safety Set) n=28 participants at risk Subjects in the Treatment Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.	Smartpatch Control Group (Safety Set) n=13 participants at risk Subjects in the Control Group had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, but did not receive any electrical stimulation.
Nervous system disorders Focal seizure (occurred prior to receiving any intervention)	1.1% 1/88 • Number of events 1 • Adverse events were collected over a period of 29 months (time from when the first subject was enrolled in April 2013 to when the last subject was completed in August 2015). At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.	0.00% 0/28 • Adverse events were collected over a period of 29 months (time from when the first subject was enrolled in April 2013 to when the last subject was completed in August 2015). At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.	0.00% 0/13 • Adverse events were collected over a period of 29 months (time from when the first subject was enrolled in April 2013 to when the last subject was completed in August 2015). At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.

Other adverse events

Additional Information

Clinical Affairs

SPR Therapeutics

Phone: 216-378-9108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: LTE60