RECRUITING

Sustained Acoustic Medicine for Osteoarthritis Pain

Conditions

Osteoarthritis Continuous ultrasound Sustained Acoustic Medicine Musculoskeletal Injuries Low Intensity Continuous Ultrasound Pain Joint Injury

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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 compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

Official Title

Sustained Acoustic Medicine for Osteoarthritis Pain

Quick Facts

Study Start:2022-02-14

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05254574

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:35 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD). * Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA * Are between 35-85 years of age * Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment * Report that knee, shoulder, elbow, ankle, hip, or spine pain 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 treatment 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. * 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). * Have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months. * Requires oxygen support * Has an allergy to aspirin or other NSAIDs * Have a secondary cause of arthritis (metabolic or inflammatory)

Inclusion Criteria

Exclusion Criteria

* Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* Are between 35-85 years of age
* Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
* Report that knee, shoulder, elbow, ankle, hip, or spine pain 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 treatment 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.
* 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).
* Have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
* Requires oxygen support
* Has an allergy to aspirin or other NSAIDs
* Have a secondary cause of arthritis (metabolic or inflammatory)

Contacts and Locations

Study Contact

George K. Lewis, Ph.D.

CONTACT

888-202-9831

george@zetroz.com

Principal Investigator

Sandra Winkler, Ph.D.

PRINCIPAL_INVESTIGATOR

James A. Haley Veterans Hospital

Study Locations (Sites)

James A Haley Veterans Hospital

Tampa, Florida, 33511

United States

Collaborators and Investigators

Sponsor: ZetrOZ, Inc.

Sandra Winkler, Ph.D., PRINCIPAL_INVESTIGATOR, James A. Haley Veterans Hospital

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 Date2022-02-14

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2022-02-14

Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

Continuous ultrasound
Sustained Acoustic Medicine
Musculoskeletal Injuries
Low Intensity Continuous Ultrasound
Pain
Joint Injury
Osteoarthritis

Additional Relevant MeSH Terms

Osteoarthritis