SAM + Diclofenac for Broken Bone Pain

Phase 1

Recruiting

Led By George K. Lewis, Ph.D.

Research Sponsored by ZetrOZ, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 12 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if LITUS can reduce bone-fracture pain and speed up return to work over 12 weeks.

Who is the study for?

This trial is for adults aged 18-80 with a physician-diagnosed bone fracture, experiencing moderate pain that affects their quality of life. Participants must not use other pain treatments or start new medications during the study and should be able to apply the treatment themselves.

What is being tested?

The trial tests if Sustained Acoustic Medicine (SAM), combined with a Diclofenac patch, can reduce pain from bone fractures over 12 weeks better than just the Diclofenac patch alone. It also looks at whether SAM helps patients return to work sooner.

What are the potential side effects?

Potential side effects may include skin irritation where the device or patch is applied, possible discomfort from using the device, and typical side effects of Diclofenac like digestive issues or local skin reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 12 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAM Ultrasound Device and Diclofenac PatchExperimental Treatment2 Interventions

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts/cm\^2 intensity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sustained Acoustic Device with 2.5% Diclofenac Patch

2022

Completed Phase 2

~290

2.5% Diclofenac Patches

2023

Completed Phase 2

~200