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Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sustained Acoustic Device with 2.5% Diclofenac Patch

Placebo Sustained Acoustic Device with 0% Diclofenac Patch

1% Diclofenac Topical Gel

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Continuous ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Joint Injury, Osteoarthritis

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 35-80 years of age
Report a frequent pain score between 3-7 (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 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 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 a secondary cause of arthritis (metabolic or inflammatory)

Sites / Locations

James A Haley Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

SAM Ultrasound Device and Diclofenac Patch

Placebo SAM Ultrasound Device and Diclofenac Patch

Over the Counter Arthritis Pain Gel

Arm Description

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.

Patients receive placebo treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 0% diclofenac patch.

Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.

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-

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05254574

First Posted

February 14, 2022

Last Updated

June 23, 2023

Sponsor

ZetrOZ, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05254574

Brief Title

Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Official Title

Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

February 14, 2022 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

February 28, 2023 (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 compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of knee osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

6. Conditions and Keywords

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

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAM Ultrasound Device and Diclofenac Patch

Arm Type

Experimental

Arm Description

Arm Title

Placebo SAM Ultrasound Device and Diclofenac Patch

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 0% diclofenac patch.

Arm Title

Over the Counter Arthritis Pain Gel

Arm Type

Active Comparator

Arm Description

Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.

Intervention Type

Device

Intervention Name(s)

Sustained Acoustic Device with 2.5% Diclofenac Patch

Other Intervention Name(s)

ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS DeviceWearable, Long Duration Low-Intensity Device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Placebo Sustained Acoustic Device with 0% Diclofenac Patch

Other Intervention Name(s)

ZetrOZ Ultrasound Device, Ultrasound Device, Long Duration Ultrasound, LITUS DeviceWearable, Long Duration Low-Intensity Device

Intervention Description

Patients apply the placebo SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% Diclofenac patches.

Intervention Type

Drug

Intervention Name(s)

1% Diclofenac Topical Gel

Other Intervention Name(s)

Voltaren

Intervention Description

Topical pain-relief gel

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-

Time Frame

Through study completion, average of 8 weeks

Title

Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Time Frame

Time Frame: Through study completion, average of 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 35-80 years of age Report a frequent pain score between 3-7 (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 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 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 a secondary cause of arthritis (metabolic or inflammatory)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Winkler, Ph.D.

Organizational Affiliation

James A. Haley Veterans Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

James A Haley Veterans Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33511

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

background

PubMed Identifier

33076955

Citation

Best TM, Petterson S, Plancher K. Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management. J Orthop Surg Res. 2020 Oct 19;15(1):481. doi: 10.1186/s13018-020-01987-x.

Results Reference

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PubMed Identifier

30326947

Citation

Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.

Results Reference

background

PubMed Identifier

25788823

Citation

Langer MD, Levine V, Taggart R, Lewis GK, Hernandez L, Ortiz R. Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. Proc IEEE Annu Northeast Bioeng Conf. 2014 Apr;2014:14789673. doi: 10.1109/NEBEC.2014.6972850.

Results Reference

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Sustained Acoustic Medicine for Knee Osteoarthritis Pain

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