Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

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)

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

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)

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

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)

Population: 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.

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)

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

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)

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)

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

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)

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)

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

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

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)

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);

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

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)

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)

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

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)

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)

Population: 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.

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)

Population: 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.

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)

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)

Population: 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.