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

Primary Purpose

Osteo Arthritis Knee, Arthritis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sustained Acoustic Device with 2.5% Diclofenac Patch
Sustained Acoustic Device with 0% Diclofenac Patch
2.5% Diclofenac Patches
Sponsored by
ZetrOZ, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

  • Orthopaedic FoundationRecruiting
  • ZetrOZ SystemsRecruiting
  • Cayuga Medical Center - Medical Pain ConsultantsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

SAM Ultrasound Device and Diclofenac Patch

SAM Ultrasound Device and SAM Patch

Diclofenac Patch

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/cm^2 intensity.

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

Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.

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.
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

First Posted
May 20, 2023
Last Updated
June 23, 2023
Sponsor
ZetrOZ, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05882812
Brief Title
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
Official Title
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-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.
Detailed Description
This is an 8-week 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 8 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. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol. Over 120 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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAM Ultrasound Device and Diclofenac Patch
Arm Type
Experimental
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/cm^2 intensity.
Arm Title
SAM Ultrasound Device and SAM Patch
Arm Type
Active Comparator
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 SAM patch(0% diclofenac).
Arm Title
Diclofenac Patch
Arm Type
Active Comparator
Arm Description
Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
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 Device Wearable, 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^2 with 2.5% Diclofenac patches.
Intervention Type
Device
Intervention Name(s)
Sustained Acoustic Device with 0% Diclofenac Patch
Other Intervention Name(s)
ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device Wearable, Long Duration Low-Intensity Device
Intervention Description
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
Intervention Type
Drug
Intervention Name(s)
2.5% Diclofenac Patches
Intervention Description
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
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.
Time Frame
Through study completion, average of 8 weeks
Title
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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).
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George K. Lewis, Ph.D.
Phone
8882029831
Email
george@zetroz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George K Lewis, Ph.D.
Organizational Affiliation
ZetrOZ Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Foundation
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Petterson, MPT, Ph.D.
Phone
203-869-2002
Ext
14
Email
spetterson@ofals.org
Facility Name
ZetrOZ Systems
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George K Lewis, Ph.D.
Phone
888-202-9831
Email
george@zetroz.com
Facility Name
Cayuga Medical Center - Medical Pain Consultants
City
Dryden
State/Province
New York
ZIP/Postal Code
13053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Ortiz, DO
Phone
607-844-9979
Email
drortizmpc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.samrecover.com
Description
Class II Medical Device

Learn more about this trial

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

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