RecruitingPhase 1NCT05883241

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture


Sponsor

ZetrOZ, Inc.

Enrollment

90 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 2.5% Diclofenac Patches and Sustained Acoustic Device with 2.5% Diclofenac Patch for people with bone fracture and fresh fracture. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESustained Acoustic Device with 2.5% Diclofenac Patch

Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.

DRUG2.5% Diclofenac Patches

Topical pain relief-gel worn during treatment via SAM patch.


Locations(2)

ZetrOZ Systems LLC

Trumbull, Connecticut, United States

National Sports Medicine Institute

Lansdowne, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05883241


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