Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

March 3, 2025 updated by: ZetrOZ, Inc.

The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period.

The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain.

Secondary objectives are to assess the ability of LITUS to improve joint function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 24-week study to clinically evaluate the effectiveness of the wireless Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. 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 24 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. Assessments on quality of life & function, depression & anxiety, and sleep will be performed prior to the patient beginning the protocol, at 8 weeks, 16 weeks and at the conclusion of the protocol.

Over 300 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
  • Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
  • Are between 50-85 years of age
  • Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
  • Report that knee 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 ultrasound gel 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 use of opioid and/or non-opioid analgesic medications.
  • Be willing to discontinue any other interventional treatment modalities on the knee 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).
  • Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.
  • Are currently taking steroids.
  • Have any contraindication to radiograph.
  • Have a secondary cause of arthritis (metabolic or inflammatory).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 24 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
  • Long Duration Low-Intensity Device
  • LITUS Device Wearable
Active Comparator: SAM Ultrasound Device and SAM Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with SAM patch (0% diclofenac).
Device: Sustained Acoustic Device with 0% Diclofenac Patch
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
Other Names:
  • ZetrOZ Ultrasound Device
  • Wearable Ultrasound Device
  • Long Duration Ultrasound
  • Long Duration Low-Intensity Device
  • LITUS Device Wearable
Active Comparator: Diclofenac Patch
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.
Drug: 2.5% Diclofenac Patches
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
Placebo Comparator: SAM Patch
Patients wear 0% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.
Other: SAM Patch
Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.

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
Time Frame: Through study completion, average of 24 weeks.
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Through study completion, average of 24 weeks.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Through study completion, average of 24 weeks.
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
Through study completion, average of 24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
Time Frame: Through study completion, average of 24 weeks.
Subject-reported change in overall pain on a scale, -7 = worst, +7 = best.
Through study completion, average of 24 weeks.
Change in the Pain & Sleep Questionnaire (PSQ-3)
Time Frame: Through study completion, average of 24 weeks.
Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact.
Through study completion, average of 24 weeks.
Change in Depression Anxiety Stress Scale (DASS21)
Time Frame: Through study completion, average of 24 weeks.
Subject-reported measures of depression, anxiety, and stress on a scale of 0-3, 0 being not applicable, 1 meaning applicable to some degree, 2 meaning applicable often, and 3 meaning applicable most of the time. Questions are divided into three categories: depression, anxiety, and stress.
Through study completion, average of 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZetrOZ, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-01-2024

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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