N/A
N=88
Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
Post-stroke Shoulder Pain · Hemiplegic Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT01847885 ↗Enrolled (actual)
88
Serious AEs
0.8%
Results posted
Oct 2017
Primary outcome: Primary: Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) — 7.1; 6.6; 4.1; 4.1 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smartpatch Peripheral Nerve Stimulation (PNS) System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- SPR Therapeutics, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT) |
7.1; 6.6; 4.1; 4.1; 3.1; 2.5 | — |
| PRIMARY Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups |
16; 3 | — |
| SECONDARY Change From Baseline Shoulder Pain Interference at End of Treatment |
4.8; 5.0; 1.8; 2.6; 3.1; 2.4 | — |
| SECONDARY Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment |
7.1; 6.6; 4.3; 4.3 | — |
| SECONDARY Change From Baseline Quality of Life at End of Treatment |
38.0; 35.4; 4.8; 3.5; 54.3; 47.9 | — |
| SECONDARY Change From Baseline Average Pain Intensity at End of Treatment |
5.2; 4.8; 2.6; 2.4; 2.7; 2.5 | — |
| SECONDARY Patient Global Impression of Change at End of Treatment |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Change in Pain Medication Usage at End of Treatment |
6; 4; 16; 8; 3; 1 | — |
| SECONDARY Clinical Global Impression of Improvement at End of Treatment |
0; 0; 0; 0; 0; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01847885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.