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

Primary Purpose

Osteo Arthritis Knee, Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sustained Acoustic Device with 1% Diclofenac patch

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring low-intensity ultrasound, drug delivery, sonophoresis, transdermal drug delivery, Non-Steroidal anti-inflammatory Drugs, sustained acoustic medication, low intensity continuous ultrasound

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Cayuga Medical Center -

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: SAM ultrasound and diclofenac patch

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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)

Full Information

NCT ID

NCT04391842

First Posted

February 17, 2020

Last Updated

June 23, 2023

Sponsor

ZetrOZ, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04391842

Brief Title

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

Acronym

SAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZetrOZ, Inc.

4. Oversight

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.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee, Arthritis

Keywords

low-intensity ultrasound, drug delivery, sonophoresis, transdermal drug delivery, Non-Steroidal anti-inflammatory Drugs, sustained acoustic medication, low intensity continuous ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: SAM ultrasound and diclofenac patch

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Sustained Acoustic Device with 1% Diclofenac patch

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline

Description

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.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Ortiz, DO

Organizational Affiliation

Medical Pain Consultants

Official's Role

Study Director

Facility Information:

Facility Name

Cayuga Medical Center -

City

Dryden

State/Province

New York

ZIP/Postal Code

13053

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33408796

Citation

Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.

Results Reference

derived

Links:

URL

https://www.samrecover.com

Description

Class II Medical Device

Learn more about this trial

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

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