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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by SPR Therapeutics, LLC
Sponsor:
Information provided by (Responsible Party):
SPR Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT01847885
First received: April 23, 2013
Last updated: November 21, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 1-week ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 2-weeks ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 3-weeks ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 1-week post-treatment ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 4-weeks post-treatment ] [ Designated as safety issue: Yes ]
  • Device related adverse event rates in treatment and control groups [ Time Frame: 12-weeks post-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline Shoulder Pain Interference at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
  • Durability of change from baseline Shoulder Pain Intensity at 12-weeks beyond Treatment [ Time Frame: Baseline, 12-wks post-treatment ] [ Designated as safety issue: No ]
  • Change from Baseline Quality of Life at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
  • Change from Baseline Average Pain Intensity at End of Treatment [ Time Frame: Baseline, End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change at End of Treatment [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
  • Change in Pain Medication Usage at End of Treatment [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Improvement at End of Treatment [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • User Satisfaction with The Smartpatch System at End of Treatment [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
    User satisfaction survey

  • User Satisfaction with The Smartpatch System at 12-weeks beyond Treatment [ Time Frame: 12-week post-treatment ] [ Designated as safety issue: No ]
    User Satisfaction Survey

  • Performance of the Smartpatch System at End of Treatment [ Time Frame: End of Treatment (4-weeks of Treatment/Control) ] [ Designated as safety issue: No ]
    Assessed through User Satisfaction Survey

  • Performance of the Smartpatch System at 12-weeks beyond Treatment [ Time Frame: 12-weeks post-treatment ] [ Designated as safety issue: No ]
    Assessed through User Satisfaction Survey


Estimated Enrollment: 180
Study Start Date: April 2013
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847885

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael Schmitt    312-238-2845      
Principal Investigator: Richard L Harvey, MD         
United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Emma Kaplan    973-243-6880      
Principal Investigator: Anna M Barrett, MD         
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Carly Creelman    212-746-1857      
Principal Investigator: Michael W O'Dell, MD         
United States, North Carolina
Carolinas Rehabilitation/Carolinas Healthcare Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Marybeth Whitney, BSN    704-355-1409      
Principal Investigator: Vu Nguyen, MD         
Sponsors and Collaborators
SPR Therapeutics, LLC
  More Information

No publications provided

Responsible Party: SPR Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01847885     History of Changes
Other Study ID Numbers: 0131-CSP-000
Study First Received: April 23, 2013
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 10, 2014