Hemiplegic Shoulder Pain, Post-stroke Shoulder Pain
Conditions
Keywords
electrical stimulation, neurostimulation, neuromodulation, post-stroke shoulder pain, hemiplegic shoulder pain
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).
Interventions
DEVICESmartpatch 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).
Sponsors
SPR Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 15 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Initial Enrollment (Consented) | Pending prior to enrollment stop | 6 | 0 | 0 |
| Initial Enrollment (Consented) | Protocol Violation | 1 | 0 | 0 |
| Initial Enrollment (Consented) | Screen failure | 39 | 0 | 0 |
| Initial Enrollment (Consented) | Withdrawal by Subject | 2 | 0 | 0 |
| Randomization | Protocol Violation | 0 | 1 | 0 |
| Randomization | Screen Failure | 0 | 3 | 0 |
| Randomization | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 11.8 | 58.9 years STANDARD_DEVIATION 9.8 | 57.8 years STANDARD_DEVIATION 11.1 |
| Beck Depression Inventory score | 13.2 Beck Depression Score STANDARD_DEVIATION 9 | 17.6 Beck Depression Score STANDARD_DEVIATION 11.9 | 14.7 Beck Depression Score STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 15 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Presence of shoulder subluxation Subluxation absent | 5 Participants | 2 Participants | 7 Participants |
| Presence of shoulder subluxation Subluxation present | 23 Participants | 11 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 27 Participants |
| Time elapsed from stroke, years | 5.1 years STANDARD_DEVIATION 4.7 | 3.5 years STANDARD_DEVIATION 2.8 | 4.5 years STANDARD_DEVIATION 4.2 |
| Type of stroke Hemorrhagic | 11 Participants | 5 Participants | 16 Participants |
| Type of stroke Ischemic | 16 Participants | 10 Participants | 26 Participants |
| Type of stroke Unknown/not collected | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 28 | 0 / 13 |
| other Total, other adverse events | 0 / 88 | 22 / 28 | 9 / 13 |
| serious Total, serious adverse events | 1 / 88 | 0 / 28 | 0 / 13 |
Outcome results
Primary
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
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)
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) | Baseline diary score | 7.1 scores on a scale | Standard Deviation 1.5 |
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) | EOT diary score | 4.1 scores on a scale | Standard Deviation 2.3 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) | Baseline diary score | 6.6 scores on a scale | Standard Deviation 1.5 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) | EOT diary score | 4.1 scores on a scale | Standard Deviation 3.1 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) | Change in pain intensity from baseline | 2.5 scores on a scale | Standard Deviation 3.1 |
Primary
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
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
Population: Safety set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups | 16 device related adverse events |
| Smartpatch Control Group (Full Analysis Set) | Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups | 3 device related adverse events |
Secondary
Change From Baseline Average Pain Intensity at End of Treatment
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)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Average Pain Intensity at End of Treatment | Baseline diary score | 5.2 scores on a scale | Standard Deviation 2 |
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Average Pain Intensity at End of Treatment | EOT diary score | 2.6 scores on a scale | Standard Deviation 1.8 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Average Pain Intensity at End of Treatment | Baseline diary score | 4.8 scores on a scale | Standard Deviation 1.7 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Average Pain Intensity at End of Treatment | EOT diary score | 2.4 scores on a scale | Standard Deviation 2.2 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Average Pain Intensity at End of Treatment | Change in pain intensity from baseline | 2.5 scores on a scale | Standard Deviation 2.3 |
Secondary
Change From Baseline Quality of Life at End of Treatment
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)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Physical Component Baseline score | 38.0 scores on a scale | Standard Deviation 8.9 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Mental Component Baseline score | 54.3 scores on a scale | Standard Deviation 10.7 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Change in Mental Component score from baseline | 9.1 scores on a scale | Standard Deviation 13.2 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Physical Component Baseline score | 35.4 scores on a scale | Standard Deviation 10.4 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Mental Component Baseline score | 47.9 scores on a scale | Standard Deviation 9.5 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Quality of Life at End of Treatment | Change in Physical Component score from baseline | 3.5 scores on a scale | Standard Deviation 9.3 |
Secondary
Change From Baseline Shoulder Pain Interference at End of 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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Shoulder Pain Interference at End of Treatment | Baseline score | 4.8 scores on a scale | Standard Deviation 2.4 |
| Smartpatch Treatment Group (Full Analysis Set) | Change From Baseline Shoulder Pain Interference at End of Treatment | EOT score | 1.8 scores on a scale | Standard Deviation 1.8 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Interference at End of Treatment | Baseline score | 5.0 scores on a scale | Standard Deviation 2 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Interference at End of Treatment | EOT score | 2.6 scores on a scale | Standard Deviation 3.3 |
| Smartpatch Control Group (Full Analysis Set) | Change From Baseline Shoulder Pain Interference at End of Treatment | Change in pain interference from baseline | 2.4 scores on a scale | Standard Deviation 2.7 |
Secondary
Change in Pain Medication Usage at End of Treatment
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)
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | Decrease in pain med usage compared to baseline | 6 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | No change in pain med usage compared to baseline | 16 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | Increase in pain med usage compared to baseline | 3 Participants |
| Smartpatch Control Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | Decrease in pain med usage compared to baseline | 4 Participants |
| Smartpatch Control Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | No change in pain med usage compared to baseline | 8 Participants |
| Smartpatch Control Group (Full Analysis Set) | Change in Pain Medication Usage at End of Treatment | Increase in pain med usage compared to baseline | 1 Participants |
Secondary
Clinical Global Impression of Improvement at End of Treatment
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)
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 CGI-I was not completed for one subject in the treatment group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Minimally worse | 0 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Minimally improved | 11 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Much worse | 0 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Much improved | 10 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | No change | 1 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Very much improved | 4 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Very much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Very much improved | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Very much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Minimally worse | 1 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | No change | 3 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Minimally improved | 4 Participants |
| Smartpatch Control Group (Full Analysis Set) | Clinical Global Impression of Improvement at End of Treatment | Much improved | 5 Participants |
Secondary
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond 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.
Time frame: Baseline, 12-wks post-treatment
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Treatment Group (Full Analysis Set) | 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 |
| Smartpatch Control Group (Full Analysis Set) | Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment | Baseline diary score | 6.6 scores on a scale | Standard Deviation 1.5 |
| Smartpatch Control Group (Full Analysis Set) | 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 2.5 |
Secondary
Patient Global Impression of Change at End of Treatment
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)
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Minimally worse | 0 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Minimally improved | 11 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Much worse | 0 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Much improved | 13 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | No change | 1 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Very much improved | 2 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Very much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Very much improved | 1 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Very much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Much worse | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Minimally worse | 2 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | No change | 2 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Minimally improved | 5 Participants |
| Smartpatch Control Group (Full Analysis Set) | Patient Global Impression of Change at End of Treatment | Much improved | 3 Participants |
Post Hoc
30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)
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)
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | 30% Reduction in Pain Interference From Baseline to End of Treatment (EOT) | 24 Participants |
| Smartpatch Control Group (Full Analysis Set) | 30% Reduction in Pain Interference From Baseline to End of Treatment (EOT) | 7 Participants |
Post Hoc
Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)
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)
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT) | 25 Participants |
| Smartpatch Control Group (Full Analysis Set) | Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT) | 8 Participants |
Other Pre-specified
Performance of the Smartpatch System
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
Population: Count of participants represents Investigators responding to the survey rather than study participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Agreed time to perform procedure was acceptable | 7 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Agreed that device components performed well | 6 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Agreed that patients tolerated the procedure well | 6 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Agreed that the Smartpatch System was easy to use | 7 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Liked the size, weight, & shape of the Stimulator | 7 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | Performance of the Smartpatch System | Agreed study beneficial for most of their patients | 5 Participants |
Other Pre-specified
User Satisfaction With The Smartpatch System at 12-weeks Beyond 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.
Time frame: 12-week post-treatment
Population: Safety set (Subjects who were implanted with a Smartpatch Lead)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Reported study had positive impact on their life | 27 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Reported being satisfied with experience in study | 26 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Would recommend participation in study to a friend | 28 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with no discomfort | 20 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with some discomfort | 7 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with a lot of discomfort | 1 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with some discomfort | 4 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Reported study had positive impact on their life | 11 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with no discomfort | 9 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Reported being satisfied with experience in study | 11 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Tolerated lead placement with a lot of discomfort | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment | Would recommend participation in study to a friend | 13 Participants |
Other Pre-specified
User Satisfaction With The Smartpatch System at End of Treatment
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)
Population: Safety set (Subjects who were implanted with a Smartpatch Lead)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Reported study had positive impact on their life | 27 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Reported being satisfied with experience in study | 27 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Would recommend participation in study to a friend | 28 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with no discomfort | 16 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with some discomfort | 11 Participants |
| Smartpatch Treatment Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with a lot of discomfort | 1 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with some discomfort | 5 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Reported study had positive impact on their life | 9 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with no discomfort | 8 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Reported being satisfied with experience in study | 10 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Tolerated lead placement with a lot of discomfort | 0 Participants |
| Smartpatch Control Group (Full Analysis Set) | User Satisfaction With The Smartpatch System at End of Treatment | Would recommend participation in study to a friend | 11 Participants |