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| Name | Class |
|---|---|
| NDI Medical, LLC | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The SPR System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The SPR System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (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). | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
| Pain Intensity (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-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) |
| Device-Related Adverse Events | 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. | Total of 86 months (from when the first subjects enrolled to when the last subject completed the study) |
| Number of Subjects Who Were a Trial Stage Success | 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. | End of Treatment (EOT) |
| Number of Subjects Who Were an Implant Stage Success |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference (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). |
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Trial Stage Inclusion Criteria:
Trial Stage Exclusion Criteria:
Implant Stage Inclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States | ||
| Carolinas Healthcare System/Carolinas Rehabilitation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25251248 | Result | Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53. doi: 10.1097/PHM.0000000000000173. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Subjects | This group includes subjects that were consented, met eligibility criteria, and received Leads. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trial Stage |
|
| |||||||||||||||||||||
| Implant Stage |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Subjects | This group includes subjects that were consented, met eligibility criteria, and received Leads. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity (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). | One subject did not reach end of treatment. Due to this, the subject was not included in the end of treatment analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
|
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).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Subjects | This group includes subjects that were consented, met eligibility criteria, and received Leads. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complaints of Chest Pain | Cardiac disorders | Standard terminology | Systematic Assessment | One event was not study-related, and the relationship of one was unable to be determined |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation (redness, mild skin abrasion, or mild grade 1 pressure sore with intact skin) | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | SPRTherapeutics | 216-378-9108 | support@SPRTherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Jul 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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|
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.
| 12-weeks post IPG-Stim ON |
| Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
| Pain-Free Passive Range of Motion (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). | Baseline, 3-week (Trial Stage), 6-week (Trial Stage); |
| Quality of Life (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. | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
| Number of Participants Completing the Economic Impact Survey | 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. | Baseline |
| Emotional Functioning (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). | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
| User Satisfaction (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. | 6-week (Trial Stage) |
| Global Impact of Stimulation Therapy (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. | 3-week (Trial Stage), 6-week (Trial Stage) |
| Quality of Life (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. | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
| Pain Interference (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. | 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
| Pain-Free Passive Range of Motion (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. | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
| Emotional Functioning (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. | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
| Global Impact of Stimulation Therapy (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. | 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage) |
| User Satisfaction (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. | 12-weeks,12-months post IPG-Stim ON (Implant Stage) |
| Reduction in Arm Impairment and Improvement in Activities of Daily Living (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). | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
| Charlotte |
| North Carolina |
| 28203 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Moss Rehab/ Albert Einstein Healthcare Network | Elkins Park | Pennsylvania | 19027 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type of Stroke | Count of Participants | Participants |
|
| Stroke Onset to Enrollment | Mean | Standard Deviation | Years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pain Intensity (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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) |
|
|
|
| Primary | Device-Related Adverse Events | 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. | Posted | Count of Participants | Participants | Total of 86 months (from when the first subjects enrolled to when the last subject completed the study) |
|
|
|
| Primary | Number of Subjects Who Were a Trial Stage Success | 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. | Twenty-seven subjects completed the study through end of treatment (EOT) | Posted | Count of Participants | Participants | End of Treatment (EOT) |
|
|
|
| Primary | Number of Subjects Who Were an Implant Stage Success | 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. | Posted | Count of Participants | Participants | 12-weeks post IPG-Stim ON |
|
|
|
| Secondary | Pain Interference (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). | One subject did not reach end of treatment and was not included in the end of treatment analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
|
|
|
| Secondary | Pain-Free Passive Range of Motion (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). | One subject did not reach end of treatment and was not included in the end of treatment analysis. | Posted | Mean | Standard Deviation | Degrees | Baseline, 3-week (Trial Stage), 6-week (Trial Stage); |
|
|
|
| Secondary | Quality of Life (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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
|
|
|
| Secondary | Number of Participants Completing the Economic Impact Survey | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Emotional Functioning (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). | One subject did not reach end of treatment and was not included in the end of treatment analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
|
|
|
| Secondary | User Satisfaction (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. | 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. | Posted | Count of Participants | Participants | 6-week (Trial Stage) |
|
|
|
| Secondary | Global Impact of Stimulation Therapy (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. | One subject did not reach end of treatment and was not included in the 6-week treatment analysis. | Posted | Count of Participants | Participants | 3-week (Trial Stage), 6-week (Trial Stage) |
|
|
|
| Secondary | Quality of Life (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. | Posted | Mean | Standard Deviation | Scores on a scale | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | Pain Interference (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. | Posted | Mean | Standard Deviation | score on a scale | 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | Pain-Free Passive Range of Motion (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. | Posted | Mean | Standard Deviation | Degrees | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | Emotional Functioning (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. | Posted | Mean | Standard Deviation | Scores on a scale | 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | Global Impact of Stimulation Therapy (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. | Posted | Count of Participants | Participants | 3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | User Satisfaction (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. | Posted | Count of Participants | Participants | 12-weeks,12-months post IPG-Stim ON (Implant Stage) |
|
|
|
| Secondary | Reduction in Arm Impairment and Improvement in Activities of Daily Living (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). | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 3-week (Trial Stage), 6-week (Trial Stage) |
|
|
|
| 0 |
| 28 |
| 5 |
| 28 |
| 24 |
| 28 |
|
| Myocardial Infarction | Cardiac disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Acute heart failure exacerbation | Cardiac disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Syncope | Cardiac disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Cellulitis | Infections and infestations | Standard terminology | Systematic Assessment | Not study-related |
|
| Seizure | Nervous system disorders | Standard terminology | Systematic Assessment | Not study-related |
|
Eleven were Study-related, and one was unrelated
|
| Painful Stimulation | Product Issues | Standard terminology | Systematic Assessment | Six were study-related, and the relationship of one was unable to be determined |
|
| Painful Keloid | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Study-related |
|
| Granuloma | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Study-related |
|
| Distress | Psychiatric disorders | Standard terminology | Systematic Assessment | Study-related |
|
| Pruritus | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Study-related |
|
| Tenderness at lead exit site | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Study-related |
|
| Fall | General disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Migraines | Nervous system disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Nerve Pain | Nervous system disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Atypical sensation (Tingling/Quivering of fingers/hands or "shock-like" episode after lead removal) | General disorders | Standard terminology | Systematic Assessment | One was not study-related and the other two were unable to be determined |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Subconjunctival hematoma | General disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Vomiting | General disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Malaise | General disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Total body aches | General disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Ipsilateral spasms of upper arm and shoulder | Musculoskeletal and connective tissue disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Report of redness on hand | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Elbow stiffness and appearance of fluid | Musculoskeletal and connective tissue disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Benign tumor index finger | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment | Not study-related |
|
| Release of achilles tendon | Surgical and medical procedures | Standard terminology | Systematic Assessment | Not study-related |
|
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| 6-months post IPG stim-on |
|
| 9-months post IPG stim-on |
|
| 12-months post IPG stim-on |
|
| 24-months post IPG stim-on |
|
| 36-months post IPG stim-on |
|
|
| EOT BPI9 Score |
|
|
| BPI9 Reduction at EOT Compared to End of Placebo |
|
|
| BPI9 Reduction at EOT Compared to Baseline |
|
|
|
| EOT ROM |
|
|
| Increase in ROM at EOT Compared to End of Placebo |
|
|
| Increase in ROM at EOT Compared to Baseline |
|
|
|
| Bodily Pain; 6-week (Trial Stage) |
|
|
| Bodily Pain; Change from End of Sham to EOT |
|
|
| Role-physical; Baseline |
|
|
| Role-physical; 3-week (Trial Stage) |
|
|
| Role-physical; 6-week (Trial Stage) |
|
|
| Role-physical; Change from End of Sham to EOT |
|
|
| Role-emotional; Baseline |
|
|
| Role-emotional; 3-week (Trial Stage) |
|
|
| Role-emotional; 6-week (Trial Stage) |
|
|
| Role-emotional; Change from End of Sham to EOT |
|
|
| Mental health; Baseline |
|
|
| Mental health; 3-week (Trial Stage) |
|
|
| Mental health; 6-week (Trial Stage) |
|
|
| Mental health; Change from End of Sham to EOT |
|
|
| Physical functioning; Baseline |
|
|
| Physical functioning; 3-week (Trial) |
|
|
| Physical functioning; 6-week (Trial Stage) |
|
|
| Physical functioning; Change from EOS to EOT |
|
|
| Social functioning; Baseline |
|
|
| Social functioning; 3-week (Trial Stage) |
|
|
| Social functioning; 6-week (Trial Stage) |
|
|
| Social functioning; Change from End of Sham to EOT |
|
|
| Vitality; Baseline |
|
|
| Vitality; 3-week (Trial Stage) |
|
|
| Vitality; 6-week (Trial Stage) |
|
|
| Vitality; Change from End of Sham to EOT |
|
|
| General Health; Baseline |
|
|
| General Health; 3-week (Trial Stage) |
|
|
| General Health; 6-week (Trial Stage) |
|
|
| General Health; Change from End of Sham to EOT |
|
|
|
| EOT BDI-II Score |
|
|
| BDI-II Reduction at EOT Compared to End of Placebo |
|
|
| BDI-II Reduction at EOT Compared to Baseline |
|
|
|
| Minimally worse |
|
| No Change |
|
| Minimally improved |
|
| Much improved |
|
| Very much improved |
|
| 6-week (Trial Stage) |
|
|
|
| Bodily pain; 9-months (Implant Stage) |
|
| Bodily pain; 12-months (Implant Stage) |
|
| Role-physical; 3-weeks (Implant Stage) |
|
| Role-physical; 12-weeks (Implant Stage) |
|
| Role-physical; 6-months (Implant Stage |
|
| Role-physical; 9-months (Implant Stage |
|
| Role-physical; 12-months (Implant Stage |
|
| Role-emotional; 3-weeks (Implant Stage) |
|
| Role-emotional; 12-weeks (Implant Stage) |
|
| Role-emotional; 6-months (Implant Stage) |
|
| Role-emotional; 9-months (Implant Stage) |
|
| Role-emotional; 12-months (Implant Stage) |
|
| Mental health; 3-weeks (Implant Stage) |
|
| Mental health; 12-weeks (Implant Stage) |
|
| Mental health; 6-months (Implant Stage) |
|
| Mental health; 9-months (Implant Stage) |
|
| Mental health; 12-months (Implant Stage) |
|
| Physical functioning; 3-weeks (Implant Stage) |
|
| Physical functioning; 12-weeks (Implant Stage) |
|
| Physical functioning; 6-months (Implant Stage) |
|
| Physical functioning; 9-months (Implant Stage) |
|
| Physical functioning; 12-months (Implant Stage) |
|
| Social functioning; 3-weeks (Implant Stage) |
|
| Social functioning; 12-weeks (Implant Stage) |
|
| Social functioning; 6-months (Implant Stage) |
|
| Social functioning; 9-months (Implant Stage) |
|
| Social functioning; 12-months (Implant Stage) |
|
| Vitality; 3-weeks (Implant Stage) |
|
| Vitality; 12-weeks (Implant Stage) |
|
| Vitality; 6-months (Implant Stage) |
|
| Vitality; 9-months (Implant Stage) |
|
| Vitality; 12-months (Implant Stage) |
|
| General health; 3-weeks (Implant Stage) |
|
| General health; 12-weeks (Implant Stage) |
|
| General health; 6-months (Implant Stage) |
|
| General health; 9-months (Implant Stage) |
|
| General health; 12-months (Implant Stage) |
|
| Title | Measurements |
|---|---|
|
| 6-months post IPG stim-on |
|
| 9-months post IPG stim-on |
|
| 12-months post IPG stim-on |
|
| 24-months post IPG stim-on |
|
| 36-months post IPG stim-on |
|
| Title | Measurements |
|---|---|
|
| 9-months post IPG stim-on |
|
| 12-months post IPG stim-on |
|
| Title | Measurements |
|---|---|
|
| 9-months post IPG stim-on |
|
| 12-months post IPG stim-on |
|
| No change |
|
| Minimally improved |
|
| Much improved |
|
| Very much improved |
|
| 12-weeks (Implant Stage) |
|
| 6-months (Implant Stage) |
|
| 9-months (Implant Stage) |
|
| 12-months (Implant Stage) |
|
| 24-months (Implant Stage) |
|
| 36-months (Implant Stage) |
|
| Title | Measurements |
|---|---|
|
| Pleased with the SPR System 12-mths Implant Stage |
|
| Would recommend to a friend 12-wks Implant Stage |
|
| Would recommend to a friend 12-mths Implant Stage |
|
| Wanted to participate again 12-wks Implant Stage |
|
| Wanted to participate again 12-mnths Implant Stage |
|
| Positive impact on life 12-wks Implant Stage |
|
| Positive impact on life 12-mnths Implant Stage |
|
|
| 6-weeks SULCS Score (Trial Stage) |
|
|