Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

• Sponsor: SPR Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01094301
• Collaborator: NDI Medical, LLC (Industry)
• Enrollment: 28
• Locations: 4
• Arm: 1
• Duration (Months): 87.8
• Patients Per Site: 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Device: The SPR System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jul 25, 2017
• Actual Study Completion Date: Jul 25, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: The SPR System The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Device: The SPR System; The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Outcome Measures

Primary Outcome Measures

1. Pain Intensity (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage)]

   Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).

2. Pain Intensity (Implant Stage) [3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)]

   Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.

3. Device-Related Adverse Events [Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)]

   At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.

4. Number of Subjects Who Were a Trial Stage Success [End of Treatment (EOT)]

   The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.

5. Number of Subjects Who Were an Implant Stage Success [12-weeks post IPG-Stim ON]

   Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.

Secondary Outcome Measures

1. Pain Interference (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage)]

   Subjects were asked 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 an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).

2. Pain-Free Passive Range of Motion (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage);]

   Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).

3. Quality of Life (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage)]

   Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for Baseline, 3-week (End of Placebo), and 6-week (End of Treatment) were reported.

4. Number of Participants Completing the Economic Impact Survey [Baseline]

   Subjects were asked to document pain medication, doctor visits, supplies, related treatments, need for caregivers, time spent in skilled nursing facilities, and lost work due to their shoulder pain. This data was collected from subjects at Baseline and asked to recall this data for the 6-months prior to study enrollment. National average costs were not available for these data points, and therefore the overall economic impact of shoulder pain could not be reported.

5. Emotional Functioning (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage)]

   Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).

6. User Satisfaction (Trial Stage) [6-week (Trial Stage)]

   Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the Smartpatch Stimulation System as a method for managing post-stroke shoulder pain.

7. Global Impact of Stimulation Therapy (Trial Stage) [3-week (Trial Stage), 6-week (Trial Stage)]

   The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.

8. Quality of Life (Implant Stage) [3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)]

   Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months, post IPG-Stim ON were reported.

9. Pain Interference (Implant Stage) [3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)]

   Subjects were asked 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 an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim On.

10. Pain-Free Passive Range of Motion (Implant Stage) [3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)]

    Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.

11. Emotional Functioning (Implant Stage) [3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)]

    Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.

12. Global Impact of Stimulation Therapy (Implant Stage) [3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)]

    The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.

13. User Satisfaction (Implant Stage) [12-weeks,12-months post IPG-Stim ON (Implant Stage)]

    Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the IPG System as a method for managing post-stroke shoulder pain.

14. Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage) [Baseline, 3-week (Trial Stage), 6-week (Trial Stage)]

    Subjects were asked to assess their arm impairment using the Stroke Upper Limb Capacity Scale (SULCS) test. The SULCS is a validated upper limb capacity scale which includes tasks directly related to activities of daily living individuals experience in their home environment. The SULCS consists of 10 items, with each item having a possible score of 0 or 1: 3 items for arm capacity without active hand capacity; 4 items for arm capacity and basic hand capacity; and, 3 items for complex hand capacity. These scores were summed with a higher score indicating better capacity, with 10 being the max score. The average score across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Trial Stage).

Eligibility Criteria

Criteria

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

Trial Stage Inclusion Criteria:

• At least 21 years of age

• Post-stroke shoulder pain

Trial Stage Exclusion Criteria:

• Use of habit-forming (narcotic) medications

• History of recurrent skin infections

• Bleeding disorder

• 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

Implant Stage Inclusion Criteria

• Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical Center	New York	New York	United States	10065
2	Carolinas Healthcare System/Carolinas Rehabilitation	Charlotte	North Carolina	United States	28203
3	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
4	Moss Rehab/ Albert Einstein Healthcare Network	Elkins Park	Pennsylvania	United States	19027

Sponsors and Collaborators

• SPR Therapeutics, Inc.
• NDI Medical, LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2017

More Information

Publications

None provided.

• Responsible Party: SPR Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01094301
• Other Study ID Numbers: NDI-0122-CSP-001
• First Posted: Mar 26, 2010
• Last Update Posted: Sep 12, 2018
• Last Verified: Sep 1, 2018

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

Study Results

Participant Flow

Recruitment Details	Recruitment began in April 2010 and was concluded in March 2016. 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	In the original study design, subjects who completed the trial stage and were a success were enrolled in the fully implantable phase. In the revised study design, subjects were required to be both a trial stage success and have a return of pain to be enrolled into the fully implantable phase.

Arm/Group Title	Enrolled Subjects
Arm/Group Description	This group includes subjects that were consented, met eligibility criteria, and received Leads.
Period Title: Trial Stage
STARTED	28
Subjects Who Received Smartpatch Lead	28
COMPLETED	27
NOT COMPLETED	1
Period Title: Trial Stage
STARTED	13
Met Criteria for Implant Stage	7
Subjects Who Received SPR IPG	5
COMPLETED	5
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Enrolled Subjects
Arm/Group Description	This group includes subjects that were consented, met eligibility criteria, and received Leads.
Overall Participants	28
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	56.2 (11.0)
Sex: Female, Male (Count of Participants)
Female	13 46.4%
Male	15 53.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	28 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	14 50%
White	14 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Type of Stroke (Count of Participants)
Hemorrhagic only	1 3.6%
Hemorrhagic and Intracerebral hemorrhage (ICH)	3 10.7%
Intracerebral hemorrhage	2 7.1%
Subarachnoid hemorrhage	1 3.6%
Ischemic only	20 71.4%
Ischemic and Intracerebral hemorrhage (ICH)	1 3.6%
Stroke Onset to Enrollment (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	2.7 (2.5)

Outcome Measures

1. Primary Outcome

Title	Pain Intensity (Trial Stage)
Description	Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

One subject did not reach end of treatment. Due to this, the subject was not included in the end of treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Baseline BPI3 Score	8.2 (1.4)
End of Placebo BPI3 Score	6.1 (1.8)
EOT BPI3 Score	5.0 (2.5)
Placebo Effect	2.1 (1.9)
Treatment Effect	1.0 (2.2)
Reduction at EOT Compared to Baseline	3.1 (2.4)

2. Primary Outcome

Title	Pain Intensity (Implant Stage)
Description	Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.
Time Frame	3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

13 subjects were a trial stage success, 7 of which meet the eligibility criteria for the implant stage, and 5 of the subjects continued on to have the SPR IPG implanted.

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
3-weeks post IPG stim-on	2.0 (1.3)
6-weeks post IPG stim-on	0.3 (0.8)
12-weeks post IPG stim-on	0.4 (0.9)
6-months post IPG stim-on	1.6 (1.8)
9-months post IPG stim-on	0.6 (1.3)
12-months post IPG stim-on	0.8 (1.3)
24-months post IPG stim-on	1.6 (3.0)
36-months post IPG stim-on	1.2 (1.6)

3. Primary Outcome

Title	Device-Related Adverse Events
Description	At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Time Frame	Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enrolled Subjects
Arm/Group Description	This group includes subjects that were consented, met eligibility criteria, and received Leads.
Measure Participants	28
Subjects who reported device related AEs	20 71.4%
Subjects who did not report any device related AEs	8 28.6%

4. Primary Outcome

Title	Number of Subjects Who Were a Trial Stage Success
Description	The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.
Time Frame	End of Treatment (EOT)

Outcome Measure Data

Analysis Population Description

Twenty-seven subjects completed the study through end of treatment (EOT)

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	27
Count of Participants [Participants]	13 46.4%

5. Primary Outcome

Title	Number of Subjects Who Were an Implant Stage Success
Description	Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.
Time Frame	12-weeks post IPG-Stim ON

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
Count of Participants [Participants]	5 17.9%

6. Secondary Outcome

Title	Pain Interference (Trial Stage)
Description	Subjects were asked 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 an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

One subject did not reach end of treatment and was not included in the end of treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Baseline BPI9 Score	6.2 (2.5)
End of Placebo BPI9 Score	4.7 (2.3)
EOT BPI9 Score	3.2 (3.0)
BPI9 Reduction at EOT Compared to End of Placebo	1.3 (2.1)
BPI9 Reduction at EOT Compared to Baseline	2.9 (2.9)

7. Secondary Outcome

Title	Pain-Free Passive Range of Motion (Trial Stage)
Description	Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage);

Outcome Measure Data

Analysis Population Description

One subject did not reach end of treatment and was not included in the end of treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Baseline ROM	89.8 (53.1)
End of Placebo ROM	102.8 (49.0)
EOT ROM	119.5 (38.6)
Increase in ROM at EOT Compared to End of Placebo	17.5 (41.3)
Increase in ROM at EOT Compared to Baseline	31.2 (51.7)

8. Secondary Outcome

Title	Quality of Life (Trial Stage)
Description	Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for Baseline, 3-week (End of Placebo), and 6-week (End of Treatment) were reported.
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

Computer analysis of the available data was not completed for four subjects at baseline, six subjects at 3-weeks, and eight subjects at end of treatment. Additionally, one subject did not reach end of treatment and was not included in the end of treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	24
Bodily Pain; Baseline	32.2 (5.7)
Bodily Pain; 3-week (Trial Stage)	36.2 (6.3)
Bodily Pain; 6-week (Trial Stage)	39.4 (7.0)
Bodily Pain; Change from End of Sham to EOT	3.4 (5.7)
Role-physical; Baseline	29.8 (8.4)
Role-physical; 3-week (Trial Stage)	30.7 (10.3)
Role-physical; 6-week (Trial Stage)	33.6 (9.1)
Role-physical; Change from End of Sham to EOT	2.9 (5.6)
Role-emotional; Baseline	35.7 (14.6)
Role-emotional; 3-week (Trial Stage)	34.2 (15.7)
Role-emotional; 6-week (Trial Stage)	38.6 (13.6)
Role-emotional; Change from End of Sham to EOT	3.0 (9.8)
Mental health; Baseline	43.1 (11.5)
Mental health; 3-week (Trial Stage)	44.8 (11.7)
Mental health; 6-week (Trial Stage)	48.5 (9.4)
Mental health; Change from End of Sham to EOT	3.5 (7.6)
Physical functioning; Baseline	27.3 (9.6)
Physical functioning; 3-week (Trial)	27.3 (11.2)
Physical functioning; 6-week (Trial Stage)	29.6 (11.2)
Physical functioning; Change from EOS to EOT	2.5 (5.3)
Social functioning; Baseline	39.6 (12.5)
Social functioning; 3-week (Trial Stage)	39.3 (12.9)
Social functioning; 6-week (Trial Stage)	43.9 (10.2)
Social functioning; Change from End of Sham to EOT	3.1 (8.8)
Vitality; Baseline	45.5 (7.2)
Vitality; 3-week (Trial Stage)	45.4 (8.0)
Vitality; 6-week (Trial Stage)	48.0 (8.6)
Vitality; Change from End of Sham to EOT	1.9 (6.6)
General Health; Baseline	42.4 (11.0)
General Health; 3-week (Trial Stage)	39.9 (8.6)
General Health; 6-week (Trial Stage)	41.1 (9.0)
General Health; Change from End of Sham to EOT	1.0 (6.6)

9. Secondary Outcome

Title	Number of Participants Completing the Economic Impact Survey
Description	Subjects were asked to document pain medication, doctor visits, supplies, related treatments, need for caregivers, time spent in skilled nursing facilities, and lost work due to their shoulder pain. This data was collected from subjects at Baseline and asked to recall this data for the 6-months prior to study enrollment. National average costs were not available for these data points, and therefore the overall economic impact of shoulder pain could not be reported.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Subjects who completed economic impact survey	25 89.3%
Subjects not completing economic impact survey	3 10.7%

10. Secondary Outcome

Title	Emotional Functioning (Trial Stage)
Description	Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

One subject did not reach end of treatment and was not included in the end of treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Baseline BDI-II Score	13.4 (8.8)
End of Placebo BDI-II Score	14.8 (10.0)
EOT BDI-II Score	12.9 (9.9)
BDI-II Reduction at EOT Compared to End of Placebo	1.6 (6.9)
BDI-II Reduction at EOT Compared to Baseline	0 (7.1)

11. Secondary Outcome

Title	User Satisfaction (Trial Stage)
Description	Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the Smartpatch Stimulation System as a method for managing post-stroke shoulder pain.
Time Frame	6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

This survey was not a part of the original study design. It was administered to 21 subjects. Additionally, one subject did not answer the questions related to their study experience.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	20
Reported study had positive impact on their life	18 64.3%
Reported being satisfied with experience in study	19 67.9%
Would recommend participation in study to a friend	20 71.4%

12. Secondary Outcome

Title	Global Impact of Stimulation Therapy (Trial Stage)
Description	The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Time Frame	3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

One subject did not reach end of treatment and was not included in the 6-week treatment analysis.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	28
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No Change	5 17.9%
Minimally improved	17 60.7%
Much improved	4 14.3%
Very much improved	2 7.1%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No Change	3 10.7%
Minimally improved	10 35.7%
Much improved	13 46.4%
Very much improved	1 3.6%

13. Secondary Outcome

Title	Quality of Life (Implant Stage)
Description	Subjects were asked to complete the Short Form Health Survey Version 2 (SF-36v2) to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. The eight domains are physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. The mean scores for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months, post IPG-Stim ON were reported.
Time Frame	3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
Bodily pain; 3-weeks (Implant)	42.6 (5.0)
Bodily pain; 12-weeks (Implant Stage)	46.7 (10.5)
Bodily pain; 6-months (Implant Stage)	45.1 (4.6)
Bodily pain; 9-months (Implant Stage)	43.7 (11.5)
Bodily pain; 12-months (Implant Stage)	50.1 (7.8)
Role-physical; 3-weeks (Implant Stage)	38.3 (9.5)
Role-physical; 12-weeks (Implant Stage)	35.1 (10.7)
Role-physical; 6-months (Implant Stage	40.4 (6.6)
Role-physical; 9-months (Implant Stage	37.1 (14.4)
Role-physical; 12-months (Implant Stage	37.5 (10.0)
Role-emotional; 3-weeks (Implant Stage)	47.4 (7.8)
Role-emotional; 12-weeks (Implant Stage)	38.3 (15.7)
Role-emotional; 6-months (Implant Stage)	47.4 (13.2)
Role-emotional; 9-months (Implant Stage)	39.8 (13.2)
Role-emotional; 12-months (Implant Stage)	43.6 (15.5)
Mental health; 3-weeks (Implant Stage)	52.4 (5.2)
Mental health; 12-weeks (Implant Stage)	49.0 (7.7)
Mental health; 6-months (Implant Stage)	50.7 (9.1)
Mental health; 9-months (Implant Stage)	46.8 (10.9)
Mental health; 12-months (Implant Stage)	47.9 (12.8)
Physical functioning; 3-weeks (Implant Stage)	32.1 (15.1)
Physical functioning; 12-weeks (Implant Stage)	31.3 (13.0)
Physical functioning; 6-months (Implant Stage)	31.3 (13.2)
Physical functioning; 9-months (Implant Stage)	32.1 (13.8)
Physical functioning; 12-months (Implant Stage)	24.8 (19.5)
Social functioning; 3-weeks (Implant Stage)	43.5 (2.9)
Social functioning; 12-weeks (Implant Stage)	46.7 (5.9)
Social functioning; 6-months (Implant Stage)	47.8 (8.2)
Social functioning; 9-months (Implant Stage)	45.6 (10.8)
Social functioning; 12-months (Implant Stage)	44.6 (12.3)
Vitality; 3-weeks (Implant Stage)	48.4 (2.5)
Vitality; 12-weeks (Implant Stage)	49.6 (5.4)
Vitality; 6-months (Implant Stage)	51.4 (5.4)
Vitality; 9-months (Implant Stage)	49.6 (13.3)
Vitality; 12-months (Implant Stage)	50.2 (9.6)
General health; 3-weeks (Implant Stage)	39.7 (7.2)
General health; 12-weeks (Implant Stage)	40.1 (8.0)
General health; 6-months (Implant Stage)	41.7 (8.2)
General health; 9-months (Implant Stage)	41.3 (11.6)
General health; 12-months (Implant Stage)	38.0 (15.3)

14. Secondary Outcome

Title	Pain Interference (Implant Stage)
Description	Subjects were asked 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 an 11-point numerical rating scale where 0 represents "does not interfere" and 10 represents "completely interferes." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim On.
Time Frame	3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
3-weeks post IPG stim-on	0.5 (0.4)
6-weeks post IPG stim-on	0.1 (0.2)
12-weeks post IPG stim-on	0.2 (0.4)
6-months post IPG stim-on	0.3 (0.5)
9-months post IPG stim-on	0.1 (0.2)
12-months post IPG stim-on	0.1 (0.3)
24-months post IPG stim-on	0.4 (0.8)
36-months post IPG stim-on	0.0 (0.1)

15. Secondary Outcome

Title	Pain-Free Passive Range of Motion (Implant Stage)
Description	Pain-Free Passive Range of Motion (ROM) was assessed. The average ROMs for all subjects were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Time Frame	3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
3-weeks post IPG stim-on	125.2 (25.7)
12-weeks post IPG stim-on	119.8 (11.6)
6-months post IPG stim-on	141.2 (17.5)
9-months post IPG stim-on	146.6 (20.3)
12-months post IPG stim-on	151.4 (14.6)

16. Secondary Outcome

Title	Emotional Functioning (Implant Stage)
Description	Subjects were asked to complete the Beck Depression Inventory Version 2 (BDI-II), a 21 question survey to assess depressive symptoms. Each answer was scored on a scale value of 0 to 3 and a sum was taken for all 21 questions. Higher total scores indicated more severe depressive symptoms. The standardized cutoffs used were: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, and 29-63: severe depression. Mean BDI-II scores were calculated across subjects and were reported for 3-weeks, 12-weeks, 6-months, 9-months, and 12-months post IPG-Stim ON.
Time Frame	3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
3-weeks post IPG stim-on	10.2 (9.7)
12-weeks post IPG stim-on	8.4 (7.7)
6-months post IPG stim-on	10.6 (10.1)
9-months post IPG stim-on	12.4 (12.6)
12-months post IPG stim-on	12.6 (15)

17. Secondary Outcome

Title	Global Impact of Stimulation Therapy (Implant Stage)
Description	The Patient Global Impression of Change asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved". The subjects combine all the components of their experience into one overall score.
Time Frame	3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	3 10.7%
Much improved	1 3.6%
Very much improved	1 3.6%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	1 3.6%
Much improved	3 10.7%
Very much improved	1 3.6%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	0 0%
Much improved	4 14.3%
Very much improved	1 3.6%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	0 0%
Much improved	4 14.3%
Very much improved	1 3.6%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	1 3.6%
Much improved	3 10.7%
Very much improved	1 3.6%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	0 0%
Minimally improved	0 0%
Much improved	3 10.7%
Very much improved	2 7.1%
Very much worse	0 0%
Much worse	0 0%
Minimally worse	0 0%
No change	1 3.6%
Minimally improved	0 0%
Much improved	2 7.1%
Very much improved	2 7.1%

18. Secondary Outcome

Title	User Satisfaction (Implant Stage)
Description	Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the IPG System as a method for managing post-stroke shoulder pain.
Time Frame	12-weeks,12-months post IPG-Stim ON (Implant Stage)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implant Stage Subjects (Subjects Who Received SPR IPG Implant)
Arm/Group Description	Subjects who were a trial stage success in the original study design and who had a return of pain in the revised study design were considered for the Implant Stage. Subjects who were enrolled in this phase had the SPR Implantable Pulse Generator placed in the shoulder and received electrical stimulation.
Measure Participants	5
Satisfied with experience 12-weeks Implant Stage	5 17.9%
Satisfied with experience 12-mths Implant Stage	5 17.9%
Pleased with the SPR System 12-wks Implant Stage	5 17.9%
Pleased with the SPR System 12-mths Implant Stage	5 17.9%
Would recommend to a friend 12-wks Implant Stage	5 17.9%
Would recommend to a friend 12-mths Implant Stage	5 17.9%
Wanted to participate again 12-wks Implant Stage	5 17.9%
Wanted to participate again 12-mnths Implant Stage	5 17.9%
Positive impact on life 12-wks Implant Stage	5 17.9%
Positive impact on life 12-mnths Implant Stage	5 17.9%

19. Secondary Outcome

Title	Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)
Description	Subjects were asked to assess their arm impairment using the Stroke Upper Limb Capacity Scale (SULCS) test. The SULCS is a validated upper limb capacity scale which includes tasks directly related to activities of daily living individuals experience in their home environment. The SULCS consists of 10 items, with each item having a possible score of 0 or 1: 3 items for arm capacity without active hand capacity; 4 items for arm capacity and basic hand capacity; and, 3 items for complex hand capacity. These scores were summed with a higher score indicating better capacity, with 10 being the max score. The average score across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Trial Stage).
Time Frame	Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Outcome Measure Data

Analysis Population Description

This survey was collected for the last 9 subjects enrolled in the Trial Stage due to a mid-study protocol change. Of these 9 subjects,6 subjects completed the survey at 3-weeks and 8 subjects completed the survey at 6-weeks.

Arm/Group Title	Trial Stage Subjects
Arm/Group Description	Subjects in the Trial Stage had a Smartpatch Lead placed in the shoulder, used the Smartpatch Peripheral Nerve Stimulation (PNS) System, and received electrical stimulation.
Measure Participants	9
Baseline SULCS Score	3.8 (3.7)
3-weeks SULCS Score (Trial Stage)	3.7 (3.4)
6-weeks SULCS Score (Trial Stage)	3.3 (3.4)

Adverse Events

Time Frame	Adverse events were collected over a period of 86 months (time from when the first subject was enrolled in 5/27/10 to when the last subject was completed in 7/25/17).
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
Arm/Group Description	This group includes subjects that were consented, met eligibility criteria, and received Leads.
All Cause Mortality
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Serious Adverse Events
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	5/28 (17.9%)
Cardiac disorders
Complaints of Chest Pain	1/28 (3.6%)	2
Myocardial Infarction	1/28 (3.6%)	1
Acute heart failure exacerbation	1/28 (3.6%)	1
Syncope	3/28 (10.7%)	4
Infections and infestations
Cellulitis	1/28 (3.6%)	1
Nervous system disorders
Seizure	2/28 (7.1%)	2
Other (Not Including Serious) Adverse Events
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	24/28 (85.7%)
General disorders
Fall	4/28 (14.3%)	5
Atypical sensation (Tingling/Quivering of fingers/hands or "shock-like" episode after lead removal)	3/28 (10.7%)	3
Subconjunctival hematoma	1/28 (3.6%)	1
Vomiting	1/28 (3.6%)	1
Malaise	1/28 (3.6%)	1
Musculoskeletal and connective tissue disorders
Ipsilateral spasms of upper arm and shoulder	1/28 (3.6%)	1
Elbow stiffness and appearance of fluid	1/28 (3.6%)	1
Nervous system disorders
Migraines	1/28 (3.6%)	1
Nerve Pain	1/28 (3.6%)	1
Product Issues
Painful Stimulation	4/28 (14.3%)	7
Psychiatric disorders
Distress	1/28 (3.6%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/28 (3.6%)	1
Skin and subcutaneous tissue disorders
Skin Irritation (redness, mild skin abrasion, or mild grade 1 pressure sore with intact skin)	11/28 (39.3%)	12
Painful Keloid	1/28 (3.6%)	1
Granuloma	5/28 (17.9%)	5
Pruritus	5/28 (17.9%)	5
Tenderness at lead exit site	1/28 (3.6%)	1
Report of redness on hand	1/28 (3.6%)	1
Benign tumor index finger	1/28 (3.6%)	1
Surgical and medical procedures
Release of achilles tendon	1/28 (3.6%)	1

Limitations/Caveats

[Not Specified]

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.