Clinical trial NCT01847885: Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Shoulder Pain
Hemiplegic Shoulder Pain
Keywords: electrical stimulation
neurostimulation
neuromodulation
post-stroke shoulder pain
hemiplegic shoulder pain
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
timeFrame: Baseline, End of Treatment (4-weeks of Treatment/Control)
measure: Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
timeFrame: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
Secondary outcomes:
measure: Change From Baseline Shoulder Pain Interference at End of Treatment
timeFrame: Baseline, End of Treatment (4-weeks of Treatment/Control)
measure: Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment
timeFrame: Baseline, 12-wks post-treatment
measure: Change From Baseline Quality of Life at End of Treatment
timeFrame: Baseline, End of Treatment (4-weeks of Treatment/Control)
measure: Change From Baseline Average Pain Intensity at End of Treatment
timeFrame: Baseline, End of Treatment (4-weeks of Treatment/Control)
measure: Patient Global Impression of Change at End of Treatment
timeFrame: End of Treatment (4-weeks of Treatment/Control)
measure: Change in Pain Medication Usage at End of Treatment
timeFrame: End of Treatment (4-weeks of Treatment/Control)
measure: Clinical Global Impression of Improvement at End of Treatment
timeFrame: End of Treatment (4-weeks of Treatment/Control)
Other outcomes:
measure: User Satisfaction With The Smartpatch System at End of Treatment
timeFrame: End of Treatment (4-weeks of Treatment/Control)
measure: User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment
timeFrame: 12-week post-treatment
measure: Performance of the Smartpatch System
timeFrame: At completion of study, approximately 2.5 years
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Rehabilitation/Carolinas Healthcare
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: