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

Sponsor

ZetrOZ, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05882812

Collaborator

(none)

120

Enrollment

Locations

Arms

18.9

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee Arthritis	Device: Sustained Acoustic Device with 2.5% Diclofenac Patch Device: Sustained Acoustic Device with 0% Diclofenac Patch Drug: 2.5% Diclofenac Patches	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 3, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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 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.	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 LITUS Device Wearable Long Duration Low-Intensity Device
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 8 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 LITUS Device Wearable Long Duration Low-Intensity Device
Active Comparator: Diclofenac Patch Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.	Drug: 2.5% Diclofenac Patches Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

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 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.

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

LITUS Device Wearable

Long Duration Low-Intensity Device

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 8 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

LITUS Device Wearable

Long Duration Low-Intensity Device

Active Comparator: Diclofenac Patch

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

Drug: 2.5% Diclofenac Patches

Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

Outcome Measures

Primary Outcome Measures

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline [Through study completion, average of 8 weeks]
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) [Through study completion, average of 8 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopaedic Foundation	Stamford	Connecticut	United States	06905
2	ZetrOZ Systems	Trumbull	Connecticut	United States	06611
3	Cayuga Medical Center - Medical Pain Consultants	Dryden	New York	United States	13053