At a glance
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Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
In Brief
A clinical study evaluating Active ultrasound therapy device and Placebo ultrasound therapy device for Muscle Spasm. Completed, enrolled 33 participants across 1 site.
Detailed Summary
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound device will lower the reported daily pain level of subjects suffering from trapezius muscle pain in their upper back. Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment. The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Study Details
Timeline
Interventions
low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
The placebo device appears and operates identically to the active device except that it does not emit ultrasound.