Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis

The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch; Drug: 1% Diclofenac Topical Gel

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Orthopaedic Foundation
    • Trumbull, Connecticut, United States, 06611
      • ZetrOZ Systems
  • New York
    • Dryden, New York, United States, 13053
      • Cayuga Medical Center - Medical Pain Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
• 35-80 years of age
• Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
• Report that knee pain negatively affects quality of life
• Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
• Deemed appropriate by their physician or by the study site physician to participate
• 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 initiate use of opioid and/or non-opioid analgesic medications
• Willing to discontinue any other interventional treatment modalities on the knee during the study period

Exclusion Criteria:

• Cannot successfully demonstrate the ability to put on and take off the device
• Display 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
• Have severe OA or have little to no cartilage in the knee
• Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
• Is non-ambulatory (unable to walk)
• 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 known neuropathy
• Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
• Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
• Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
• Currently taking steroids
• Have contraindication to radiograph
• Have a secondary cause of arthritis (metabolic or inflammatory)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 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.	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@ with 2.5% Diclofenac patches.; Other Names: ZetrOZ Ultrasound Device; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device
Experimental: SAM2 Ultrasound Device and Diclofenac Patch; Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour 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.	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@ with 2.5% Diclofenac patches.; Other Names: ZetrOZ Ultrasound Device; Wearable Ultrasound Device; Long Duration Ultrasound; Long Duration Low-Intensity Device; LITUS Device
Placebo Comparator: Topical Pain-Relief Gel; Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.	Drug: 1% Diclofenac Topical Gel; Topical pain-relief gel; Other Names: Voltaren

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline	Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.	8 weeks
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline	WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.	8 weeks

Collaborators and Investigators

• Sponsor: ZetrOZ, Inc.
• Investigators: Principal Investigator: George K Lewis, Ph.D., ZetrOZ Systems

Publications and helpful links

Helpful Links

• Class II Medical Device

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Non-Steroidal Anti-Inflammatory Drugs; Sustained Acoustic Medication; Low-Intensity Continuous Ultrasound
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: HF-01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes