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

Sponsor

ZetrOZ, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05883241

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bone Fracture Fresh Fracture	Device: Sustained Acoustic Device with 2.5% Diclofenac Patch Drug: 2.5% Diclofenac Patches	Phase 1

Detailed Description

This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from pain related to a bone fracture(s). The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device, during treatment, and at the completion of treatment.

Over 90 subjects will be recruited from neighboring communities to the study site(s). The study is designed to reach a diverse target patient population.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAM Ultrasound Device and Diclofenac Patch 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.	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. Other Names: ZetrOZ Ultrasound Device Wearable Ultrasound Device Long Duration Ultrasound LITUS Device Wearable Long Duration Low-Intensity Device Drug: 2.5% Diclofenac Patches Topical pain relief-gel worn during treatment via SAM patch.

Arm

Intervention/Treatment

Experimental: SAM Ultrasound Device and Diclofenac Patch

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.

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.

Other Names:

ZetrOZ Ultrasound Device

Wearable Ultrasound Device

Long Duration Ultrasound

LITUS Device Wearable

Long Duration Low-Intensity Device

Drug: 2.5% Diclofenac Patches

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

Outcome Measures

Primary Outcome Measures

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain from Baseline [Through study completion, average of 12 weeks.]
Change in the self-described pain units on a scale by patient at baseline and post-treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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.