Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain



Status:Completed
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:21 - Any
Updated:9/14/2018
Start Date:April 2010
End Date:July 25, 2017

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A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain

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.


Trial Stage Inclusion Criteria:

- At least 21 years of age

- Post-stroke shoulder pain

Trial Stage Exclusion Criteria:

- Use of habit-forming (narcotic) medications

- History of recurrent skin infections

- Bleeding disorder

- 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

Implant Stage Inclusion Criteria

- Had a "return of pain" defined as an increase in pain of at least 2 points compared to
the pain intensity score at Visit 5 and has a pain intensity score of at least 4
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Charlotte, NC
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: John Chae, MD
Phone: 216-957-3558
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Elkins Park, Pennsylvania 19027
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Elkins Park, PA
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New York, New York 10065
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New York, NY
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