Recruiting
Phase 1

Sustained Acoustic Medicine

Sponsor:

ZetrOZ, Inc.

Code:

NCT05254574

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch

2.5% Diclofenac Patches

Study Details

Brief summary:

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.

Conditions

Osteoarthritis

Study ID

NCT05254574

Start date

Feb 14, 2022

Status verified date

Feb, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Inclusion 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).

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.
  • 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)

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Interventions

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@ with 2.5% Diclofenac patches.

2.5% Diclofenac Patches

Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

Primary outcome measure

  • Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline [ Time Frame: Through study completion, average of 8 weeks ]
  • Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Time Frame: Through study completion, average of 8 weeks ]

Central Contacts and Locations

Central contacts

George K. Lewis, Ph.D.

888-202-9831george@zetroz.com

Locations

James A Haley Veterans Hospital

Recruiting

Tampa, Florida, United States, 33511

Contacts

Samuel Phillips, Ph.D.

813-558-3945Samuel.Phillips@va.gov

More Information

Sponsor

ZetrOZ, Inc.

Last update posted

Feb 27, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ZetrOZ, Inc. on 2025-02-27.