Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis (SAM)

June 23, 2023 updated by: ZetrOZ, Inc.
The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a seven day study to clinically evaluate the effectiveness of the 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 6 days, patients will self-apply the wearable SAM device with diclofenac patch to their affected knee for 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.

Up to 32 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 (Actual)

34

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Dryden, New York, United States, 13053
        • Cayuga Medical Center -

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

45 years to 85 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
  • 45-85 years of age
  • Report a frequent pain score between 3-7 (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 1% diclofenac gel provided to the subject at the initiation of the study
  • Deemed appropriate by their physician or by the study site physician to participate

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
  • Are non-ambulatory
  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: SAM ultrasound and diclofenac patch
Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Combination product: Sustained Acoustic Device with 1% Diclofenac patch

Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch

Other Names:

  • ZetrOZ ultrasound device
  • wearable ultrasound device
  • long duration ultrasound
  • LITUS device
  • long duration low intensity device

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: 7 days
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline
Time Frame: 7 days
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400)
7 days

Collaborators and Investigators

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

Sponsor

ZetrOZ, Inc.

Investigators

  • Study Director: Ralph Ortiz, DO, Medical Pain Consultants

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.

General Publications

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)

September 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF-01

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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