RECRUITING

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

Conditions

Bone Fracture Fresh Fracture Low-Intensity Ultrasound Drug Delivery Sonophoresis Transdermal Drug Delivery Non-Steroidal Anti-Inflammatory Drugs Sustained Acoustic Medication Low-Intensity Continuous Ultrasound

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05883241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

George K. Lewis, Ph.D.

CONTACT

8882029831

george@zetroz.com

Principal Investigator

George K. Lewis, Ph.D.

PRINCIPAL_INVESTIGATOR

ZetrOZ Systems

Study Locations (Sites)

ZetrOZ Systems LLC

Trumbull, Connecticut, 06611

United States

National Sports Medicine Institute

Lansdowne Town Center, Virginia, 20176

United States

Collaborators and Investigators

Sponsor: ZetrOZ, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

Low-Intensity Ultrasound
Drug Delivery
Sonophoresis
Transdermal Drug Delivery
Non-Steroidal Anti-Inflammatory Drugs
Sustained Acoustic Medication
Low-Intensity Continuous Ultrasound

Additional Relevant MeSH Terms

Bone Fracture
Fresh Fracture