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

NCT05883241 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Bone Fracture
  • Fresh Fracture

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.

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • George K. Lewis, Ph.D. · ZetrOZ Systems

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-02-01
Completion
2026-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883241 on ClinicalTrials.gov