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

SPR Therapeutics

Status: Completed

Conditions: Hemiplegic Shoulder Pain; Post-stroke Shoulder Pain

Treatments: Device: Smartpatch Peripheral Nerve Stimulation (PNS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847885

0131-CSP-000

Details and patient eligibility

About

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).

Enrollment: 88 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Smartpatch Treatment Group

Experimental group

Description:

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.

Treatment:

Device: Smartpatch Peripheral Nerve Stimulation (PNS) System

Smartpatch Control Group

Sham Comparator group

Description:

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.

Treatment:

Device: Smartpatch Peripheral Nerve Stimulation (PNS) System