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

Hemiplegic Shoulder Pain Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847885
• Other study ID #: 0131-CSP-000
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: October 12, 2017
• Start date: April 2013
• Est. completion date: November 14, 2016

Study information

• Verified date: October 2017
• Source: SPR Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 14, 2016
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegic Shoulder Pain
• Post-stroke Shoulder Pain
• Shoulder Pain
• Stroke

Intervention

Device:
• Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Locations

Country	Name	City	State
United States	Carolinas Rehabilitation/Carolinas Healthcare	Charlotte	North Carolina
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Weill Cornell Medical Center	New York	New York
United States	Kessler Foundation Research Center	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
SPR Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	End of Treatment (4-weeks of Treatment/Control)
Other	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.	12-week post-treatment
Other	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.	At completion of study, approximately 2.5 years
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.	Baseline, End of Treatment (4-weeks of Treatment/Control)
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.	16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
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.	Baseline, End of Treatment (4-weeks of Treatment/Control)
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.	Baseline, 12-wks post-treatment
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.	Baseline, End of Treatment (4-weeks of Treatment/Control)
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.	Baseline, End of Treatment (4-weeks of Treatment/Control)
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.	End of Treatment (4-weeks of Treatment/Control)
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).	End of Treatment (4-weeks of Treatment/Control)
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".	End of Treatment (4-weeks of Treatment/Control)