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RECRUITING
NCT05883241
PHASE1

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

Sponsor: ZetrOZ, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-06-01

Completion Date

2026-02-28

Last Updated

2025-02-28

Healthy Volunteers

Yes

Interventions

DEVICE

Sustained 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.

DRUG

2.5% 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