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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847885
First Posted: May 7, 2013
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SPR Therapeutics, LLC
  Purpose
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).

Condition Intervention
Post-stroke Shoulder Pain Hemiplegic Shoulder Pain Device: Smartpatch Peripheral Nerve Stimulation (PNS) System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by SPR Therapeutics, LLC:

Primary Outcome Measures:
  • Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) [ Time Frame: 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 [ Time Frame: 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 Outcome Measures:
  • Change From Baseline Shoulder Pain Interference at End of Treatment [ Time Frame: 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.

  • Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

  • Patient Global Impression of Change at End of Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Outcome Measures:
  • User Satisfaction With The Smartpatch System at End of Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 88
Study Start Date: April 2013
Study Completion Date: November 14, 2016
Primary Completion Date: August 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smartpatch Treatment Group
Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
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).
Other Name: Smartpatch System, Smartpatch
Sham Comparator: Smartpatch Control Group
Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.
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).
Other Name: Smartpatch System, Smartpatch

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847885


Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
Carolinas Rehabilitation/Carolinas Healthcare
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
SPR Therapeutics, LLC
  More Information

Responsible Party: SPR Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01847885     History of Changes
Other Study ID Numbers: 0131-CSP-000
First Submitted: April 23, 2013
First Posted: May 7, 2013
Results First Submitted: September 7, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by SPR Therapeutics, LLC:
electrical stimulation
neurostimulation
neuromodulation
post-stroke shoulder pain
hemiplegic shoulder pain

Additional relevant MeSH terms:
Stroke
Shoulder Pain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms