Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System

• Sponsor: SPR Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01847885
• Collaborator: (none)
• Enrollment: 88
• Locations: 5
• Arms: 2
• Duration (Months): 43.5
• Patients Per Site: 17.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Shoulder Pain; Hemiplegic Shoulder Pain	Device: Smartpatch Peripheral Nerve Stimulation (PNS) System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Aug 21, 2015
• Actual Study Completion Date: Nov 14, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Smartpatch Treatment Group Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.	Device: Smartpatch Peripheral Nerve Stimulation (PNS) System; The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).; Other Names: Smartpatch System, Smartpatch
Sham Comparator: Smartpatch Control Group Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.	Device: Smartpatch Peripheral Nerve Stimulation (PNS) System; The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).; Other Names: Smartpatch System, Smartpatch

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) [Baseline, End of Treatment (4-weeks of Treatment/Control)]

   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.

2. Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups [16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment]

   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.

Secondary Outcome Measures

1. Change From Baseline Shoulder Pain Interference at End of Treatment [Baseline, End of Treatment (4-weeks of Treatment/Control)]

   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.

2. Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment [Baseline, 12-wks post-treatment]

   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.

3. Change From Baseline Quality of Life at End of Treatment [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.

4. Change From Baseline Average Pain Intensity at End of Treatment [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.

5. Patient Global Impression of Change at End of Treatment [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.

6. Change in Pain Medication Usage at End of Treatment [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).

7. Clinical Global Impression of Improvement at End of Treatment [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".

Other Outcome Measures

1. User Satisfaction With The Smartpatch System at End of Treatment [End of Treatment (4-weeks of Treatment/Control)]

   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.

2. User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment [12-week post-treatment]

   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.

3. Performance of the Smartpatch System [At completion of study, approximately 2.5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• At least 21 years of age

• Post-stroke shoulder pain

• At least 6 months after stroke that caused shoulder pain

Key Exclusion Criteria:

• Use of habit-forming (narcotic) medications

• Bleeding disorder

• History of recurrent skin infections

• Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome

• Heart arrhythmia or artificial heart valves

• Uncontrolled seizures

• Implanted Electronic Device

• Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611
2	Kessler Foundation Research Center	West Orange	New Jersey	United States	07052
3	Weill Cornell Medical Center	New York	New York	United States	10065
4	Carolinas Rehabilitation/Carolinas Healthcare	Charlotte	North Carolina	United States	28203
5	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• SPR Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SPR Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01847885
• Other Study ID Numbers: 0131-CSP-000
• First Posted: May 7, 2013
• Last Update Posted: Oct 16, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by SPR Therapeutics, Inc.: electrical stimulation; neurostimulation; neuromodulation; post-stroke shoulder pain; hemiplegic shoulder pain
• Additional relevant MeSH terms: Shoulder Pain; Stroke

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Enrolled Subjects	Smartpatch Treatment Group (Full Analysis Set)	Smartpatch Control Group (Full Analysis Set)
Arm/Group Description	Subjects who signed a consent form.	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.	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.
Period Title: Initial Enrollment (Consented)
STARTED	88	0	0
Randomized	46	0	0
Full Analysis Set	43	0	0
Safety Set	41	0	0
Per Protocol Set	40	0	0
COMPLETED	40	0	0
NOT COMPLETED	48	0	0
Period Title: Initial Enrollment (Consented)
STARTED	0	31	15
Full Analysis Set	0	28	15
Safety Set	0	28	13
Per Protocol Set	0	27	13
COMPLETED	0	27	13
NOT COMPLETED	0	4	2

Baseline Characteristics

Arm/Group Title	Smartpatch Treatment Group (Full Analysis Set)	Smartpatch Control Group (Full Analysis Set)	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	28	15	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (11.8)	58.9 (9.8)	57.8 (11.1)
Sex: Female, Male (Count of Participants)
Female	10 35.7%	6 40%	16 37.2%
Male	18 64.3%	9 60%	27 62.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 10.7%	0 0%	3 7%
Not Hispanic or Latino	25 89.3%	15 100%	40 93%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 7.1%	3 20%	5 11.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 35.7%	1 6.7%	11 25.6%
White	15 53.6%	11 73.3%	26 60.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 3.6%	0 0%	1 2.3%
Type of stroke (Count of Participants)
Hemorrhagic	11 39.3%	5 33.3%	16 37.2%
Ischemic	16 57.1%	10 66.7%	26 60.5%
Unknown/not collected	1 3.6%	0 0%	1 2.3%
Time elapsed from stroke, years (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.1 (4.7)	3.5 (2.8)	4.5 (4.2)
Presence of shoulder subluxation (Count of Participants)
Subluxation present	23 82.1%	11 73.3%	34 79.1%
Subluxation absent	5 17.9%	2 13.3%	7 16.3%
Beck Depression Inventory score (Beck Depression Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Beck Depression Score]	13.2 (9.0)	17.6 (11.9)	14.7 (10.1)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
Description	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.
Time Frame	Baseline, End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Smartpatch Treatment Group (Full Analysis Set)	Smartpatch Control Group (Full Analysis Set)
Arm/Group Description	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.	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.
Measure Participants	28	15
Baseline diary score	7.1 (1.5)	6.6 (1.5)
EOT diary score	4.1 (2.3)	4.1 (3.1)
Change in pain intensity from baseline	3.1 (2.3)	2.5 (3.1)

2. Primary Outcome

Title	Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
Description	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.
Time Frame	16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	Smartpatch Treatment Group (Safety Set)	Smartpatch Control Group (Safety Set)
Arm/Group Description	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.	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.
Measure Participants	28	13
Number [device related adverse events]	16	3

3. Secondary Outcome

Title	Change From Baseline Shoulder Pain Interference at End of Treatment
Description	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.
Time Frame	Baseline, End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Baseline score	4.8 (2.4)	5.0 (2.0)
EOT score	1.8 (1.8)	2.6 (3.3)
Change in pain interference from baseline	3.1 (2.2)	2.4 (2.7)

4. Secondary Outcome

Title	Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment
Description	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.
Time Frame	Baseline, 12-wks post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Smartpatch Treatment Group (Full Analysis Set)	Smartpatch Control Group (Full Analysis Set)
Arm/Group Description	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.	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.
Measure Participants	28	15
Baseline diary score	7.1 (1.5)	6.6 (1.5)
12- weeks post-treatment diary score	4.3 (2.9)	4.3 (2.5)

5. Secondary Outcome

Title	Change From Baseline Quality of Life at End of Treatment
Description	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.
Time Frame	Baseline, End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Physical Component Baseline score	38.0 (8.9)	35.4 (10.4)
Change in Physical Component score from baseline	4.8 (7.0)	3.5 (9.3)
Mental Component Baseline score	54.3 (10.7)	47.9 (9.5)
Change in Mental Component score from baseline	4.1 (10.1)	9.1 (13.2)

6. Secondary Outcome

Title	Change From Baseline Average Pain Intensity at End of Treatment
Description	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.
Time Frame	Baseline, End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Baseline diary score	5.2 (2.0)	4.8 (1.7)
EOT diary score	2.6 (1.8)	2.4 (2.2)
Change in pain intensity from baseline	2.7 (2.3)	2.5 (2.3)

7. Secondary Outcome

Title	Patient Global Impression of Change at End of Treatment
Description	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.
Time Frame	End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Very much worse	0 0%	0 0%
Much worse	0 0%	0 0%
Minimally worse	0 0%	2 13.3%
No change	1 3.6%	2 13.3%
Minimally improved	11 39.3%	5 33.3%
Much improved	13 46.4%	3 20%
Very much improved	2 7.1%	1 6.7%

8. Secondary Outcome

Title	Change in Pain Medication Usage at End of Treatment
Description	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).
Time Frame	End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	25	13
Decrease in pain med usage compared to baseline	6 21.4%	4 26.7%
No change in pain med usage compared to baseline	16 57.1%	8 53.3%
Increase in pain med usage compared to baseline	3 10.7%	1 6.7%

9. Secondary Outcome

Title	Clinical Global Impression of Improvement at End of Treatment
Description	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".
Time Frame	End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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 CGI-I was not completed for one subject in the treatment group.

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	26	13
Very much worse	0 0%	0 0%
Much worse	0 0%	0 0%
Minimally worse	0 0%	1 6.7%
No change	1 3.6%	3 20%
Minimally improved	11 39.3%	4 26.7%
Much improved	10 35.7%	5 33.3%
Very much improved	4 14.3%	0 0%

10. Other Pre-specified Outcome

Title	User Satisfaction With The Smartpatch System at End of Treatment
Description	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.
Time Frame	End of Treatment (4-weeks of Treatment/Control)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Smartpatch Treatment Group (Safety Set)	Smartpatch Control Group (Safety Set)
Arm/Group Description	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.	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.
Measure Participants	28	13
Reported study had positive impact on their life	27 96.4%	9 60%
Reported being satisfied with experience in study	27 96.4%	10 66.7%
Would recommend participation in study to a friend	28 100%	11 73.3%
Tolerated lead placement with no discomfort	16 57.1%	8 53.3%
Tolerated lead placement with some discomfort	11 39.3%	5 33.3%
Tolerated lead placement with a lot of discomfort	1 3.6%	0 0%

11. Other Pre-specified Outcome

Title	User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment
Description	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.
Time Frame	12-week post-treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Smartpatch Treatment Group (Safety Set)	Smartpatch Control Group (Safety Set)
Arm/Group Description	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.	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.
Measure Participants	28	13
Reported study had positive impact on their life	27 96.4%	11 73.3%
Reported being satisfied with experience in study	26 92.9%	11 73.3%
Would recommend participation in study to a friend	28 100%	13 86.7%
Tolerated lead placement with no discomfort	20 71.4%	9 60%
Tolerated lead placement with some discomfort	7 25%	4 26.7%
Tolerated lead placement with a lot of discomfort	1 3.6%	0 0%

12. Other Pre-specified Outcome

Title	Performance of the Smartpatch System
Description	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.
Time Frame	At completion of study, approximately 2.5 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigators
Arm/Group Description	Investigator(s) at each site performing lead placement
Measure Participants	7
Agreed time to perform procedure was acceptable	7 25%
Agreed that device components performed well	6 21.4%
Agreed that patients tolerated the procedure well	6 21.4%
Agreed that the Smartpatch System was easy to use	7 25%
Liked the size, weight, & shape of the Stimulator	7 25%
Agreed study beneficial for most of their patients	5 17.9%

13. Post-Hoc Outcome

Title	Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)
Description	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.
Time Frame	4 weeks (from baseline visit to EOT visit)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Count of Participants [Participants]	25 89.3%	8 53.3%

14. Post-Hoc Outcome

Title	30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)
Description	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.
Time Frame	4 weeks (from baseline visit to EOT visit)

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Smartpatch Treatment Group (Per Protocol Set)	Smartpatch Control Group (Per Protocol Set)
Arm/Group Description	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.	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.
Measure Participants	27	13
Count of Participants [Participants]	24 85.7%	7 46.7%

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	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.
Arm/Group Title	Enrolled Subjects Who Did Not Receive the Study Device		Smartpatch Treatment Group (Safety Set)		Smartpatch Control Group (Safety Set)
Arm/Group Description	Subjects who were consented, but were not randomized and did not receive the study device or any intervention.		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.		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.
All Cause Mortality
	Enrolled Subjects Who Did Not Receive the Study Device		Smartpatch Treatment Group (Safety Set)		Smartpatch Control Group (Safety Set)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		0/28 (0%)		0/13 (0%)
Serious Adverse Events
	Enrolled Subjects Who Did Not Receive the Study Device		Smartpatch Treatment Group (Safety Set)		Smartpatch Control Group (Safety Set)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/88 (1.1%)		0/28 (0%)		0/13 (0%)
Nervous system disorders
Focal seizure (occurred prior to receiving any intervention)	1/88 (1.1%)	1	0/28 (0%)	0	0/13 (0%)	0
Other (Not Including Serious) Adverse Events
	Enrolled Subjects Who Did Not Receive the Study Device		Smartpatch Treatment Group (Safety Set)		Smartpatch Control Group (Safety Set)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/88 (0%)		22/28 (78.6%)		9/13 (69.2%)
Eye disorders
Lasik eye surgery	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
General disorders
General malaise after procedure	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
Nervous system disorders
Pain	0/88 (0%)	0	0/28 (0%)	0	1/13 (7.7%)	1
Increased pain (in paretic shoulder, lower back, and left lower extremity)	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
Dizziness and headache	0/88 (0%)	0	0/28 (0%)	0	1/13 (7.7%)	1
Psychiatric disorders
Depression and suicidal ideation	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
Renal and urinary disorders
Urinary Tract Infection	0/88 (0%)	0	0/28 (0%)	0	1/13 (7.7%)	3
Respiratory, thoracic and mediastinal disorders
Double pneumonia	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Lead barb retained	0/88 (0%)	0	2/28 (7.1%)	2	0/13 (0%)	0
Mild bruising under lead connector	0/88 (0%)	0	1/28 (3.6%)	2	0/13 (0%)	0
Mild erythema or irritation at lead exit site	0/88 (0%)	0	2/28 (7.1%)	2	1/13 (7.7%)	1
Papule, lead exit site	0/88 (0%)	0	1/28 (3.6%)	1	0/13 (0%)	0
Skin irritation/dermatitis from bandages	0/88 (0%)	0	9/28 (32.1%)	12	4/13 (30.8%)	4
Skin irritation/redness/or mild skin tears from Smartpatch Pad	0/88 (0%)	0	2/28 (7.1%)	2	0/13 (0%)	0
Vascular disorders
New numbness to left lower extremity	0/88 (0%)	0	0/28 (0%)	0	1/13 (7.7%)	1

Limitations/Caveats

This study included a pre-planned interim analysis for sample size re-estimation. The study was suspended because the treatment effect (both groups experienced clinically significant reductions in pain) required a sample size more than 90 subjects.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.