Sustained acoustic medicine delivered by wearable ultrasound device and topical diclofenac patch reduced patients' pain and improved clinical outcomes beyond traditional patient care.
TRUMBULL, Conn., June 5, 2023 (Newswire.com) - A new clinical study in the January Global Journal of Orthopedics Research shows that, for those who saw no improvement from physical therapy alone, ZetrOZ Systems' sustained acoustic medicine device (sam®), in combination with common topical diclofenac, reduces pain and restores health in patients with acute and chronic injuries to the shoulder, elbow, leg, and foot.
The study examined the results of long-duration sonophoresis (LDS) and the use of ultrasound to enhance the movement of medications into tissue, involving 135 patients at Yale-New Haven Health System and Sport and Orthopaedic Physical Therapy in Connecticut undergoing physical therapy for a variety of acute and chronic injuries and whose pain did not respond to physical therapy for four weeks or more.
Researchers found that patients in all age groups reported their pain decreased significantly and they felt healthier and more capable.
"Both the clinical research and daily patient real-world outcomes demonstrate that sam® helps people heal faster and improve the quality of their everyday lives," said Dr. George Lewis, founder and CEO of ZetrOZ. "This new research shows another way that sam® with topical diclofenac can improve treatment for soft tissue injuries and other conditions, by activating healing for multiple hours each day."
The new study involved sam® treatment in combination with the medication diclofenac, which together reduces inflammation and pain and is used to treat injuries to joints, muscles, and bones. Typically diclofenac can be taken orally or applied topically, but both methods can be problematic. Long-term use of oral diclofenac sodium can lead to gastrointestinal bleeding and other adverse effects while the effectiveness of topical diclofenac cream is limited because of the messy application and limited absorption.
However, recent studies have shown that using topical diclofenac in combination with continuous ultrasound can significantly increase its efficacy. The new study bears that out.
ZetrOZ's sam® is a wearable ultrasound device that delivers continuous therapy for up to four hours. The long-duration ultrasound activates cellular proliferation and generates deep heat, convection, and vasodilation, which "potentially enhances the localized drug delivery," the researchers said.
In the study, the sam® device with 2.5% diclofenac was applied to the shoulder, elbow, lower hamstring, and plantar fascia of the patients. The patients reported that the device was easy to use at home, and 100% of patients said they would be willing to keep using the device.
In addition, 98.5% of patients reported that the long-duration ultrasound improved musculoskeletal injury care. Before the study, patients reported an average pain score of 6.88 on a 10-point scale, indicating moderate to severe pain. After the treatment, patients reported that most of their pain had been eliminated, with a 4.44-point reduction to the original score.
Patients also were asked to assess how much their health had changed, on a scale of -7 ("a very great deal worse") to 7 ("a very great deal better"). The average response was 4.85, indicating the patients perceived a significant health improvement.
Patients of all ages reported improved pain and health, with younger patients reporting the greatest benefits. The degree of improvement varied by type of injury but was positive and significant across all injuries, the researchers found.
"LDS may be easily integrated into patient care to reduce the pain and accelerate the healing process," the researchers concluded. The study had a high treatment satisfaction rate, showing the ease of use of the at-home treatment option for patients.
ZetrOZ Systems' sam® technology was developed in part with funding from the National Institute of Health, National Science Foundation, Department of Defense, and NASA. ZetrOZ Systems products are designed and manufactured in the United States and are protected by 46 U.S. patents.
To learn more, visit www.samrecover.com.
About ZetrOZ Systems
ZetrOZ Systems is leading healing innovations in sports medicine, developing wearable bioelectronic devices for the delivery of sustained acoustic medicine (sam®). Researched and funded by the federal government, ZetrOZ is built on the proprietary medical technology of +46 patents and is the exclusive manufacturer and developer of the sam® product line, which is designed for the treatment of acute and chronic musculoskeletal conditions.
Source: ZetrOZ Systems