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Sustained Acoustic Medicine (SAM) for Bone Fracture Pain

This study is looking at how well a device called Sustained Acoustic Medicine (SAM) combined with 2.5% Diclofenac Patches can help reduce pain from bone fractures. The SAM device uses low-intensity ultrasound, and you would apply it daily for 1-4 hours along with the diclofenac patch. We want to see if this treatment can lower your pain score over 12 weeks. You might be able to join if you are 18-80 years old, have a doctor-diagnosed bone fracture, and your pain is between 3 and 7 on a scale of 0-10. The study aims to enroll about 90 people and is currently recruiting.

Study design
This is an interventional study planning to enroll about 90 participants to test the effectiveness of the SAM device with diclofenac.
What's involved
You would apply the treatment daily for 4 hours over 12 weeks and record your pain scores before, during, and after treatment each day.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured through study completion, which is an average of 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05883241

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
ZetrOZ, Inc.
~90 participants
Updated 2025-02-28 on ClinicalTrials.gov
What's tested:Sustained Acoustic Device with 2.5% Diclofenac Patch2.5% Diclofenac Patches

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline
Measured over Through study completion, average of 12 weeks.

Conditions

Bone Fracture
Fresh Fracture

Explore related trials

Fracture

Where it's being run

2 sites across 2 states
Connecticut1
Virginia1

Study leadership

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

Who to contact

George K. Lewis, Ph.D.
[email protected]
8882029831
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Have physician-diagnosed bone fracture
Are between 18-80 years of age
Report a pain score between 3-7 (range: 0-10) prior to enrolment
Report that pain from fracture negatively affects quality of life
Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
Are deemed appropriate by their physician or by the study site physician to participate.
Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
Not use or initiate opioid and/or non-opioid analgesic medications.
Be willing to discontinue any other interventional treatment modalities on the affected area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion

Cannot successfully demonstrate the ability to put on and take off the device.
Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
Is pregnant.
Is a prisoner.
Is non-ambulatory (unable to walk).
Has a pacemaker.
Has a malignancy in the treatment area.
Has an active infection, open sores, or wounds in the treatment area.
Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
Has a known neuropathy (disease of the brain or spinal nerves).
Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
Are currently taking steroids.

What this trial measures

  • Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from BaselineThrough study completion, average of 12 weeks.

    Change in the self-described pain units on a scale by patient at baseline and post-treatment.