Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Sponsor

ZetrOZ, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05254574

Collaborator

(none)

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Sustained Acoustic Device with 2.5% Diclofenac Patch Device: Placebo Sustained Acoustic Device with 0% Diclofenac Patch Drug: 1% Diclofenac Topical Gel	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Actual Study Start Date :

Feb 14, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 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/cm2 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@ with 2.5% Diclofenac patches. Other Names: ZetrOZ Ultrasound Device Wearable Ultrasound Device Long Duration Ultrasound LITUS DeviceWearable Long Duration Low-Intensity Device
Placebo Comparator: Placebo SAM Ultrasound Device and Diclofenac Patch 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.	Device: Placebo Sustained Acoustic Device with 0% Diclofenac Patch Patients apply the placebo SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% Diclofenac patches. Other Names: ZetrOZ Ultrasound Device Ultrasound Device Long Duration Ultrasound LITUS DeviceWearable Long Duration Low-Intensity Device
Active Comparator: Over the Counter Arthritis Pain Gel Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.	Drug: 1% Diclofenac Topical Gel Topical pain-relief gel Other Names: Voltaren

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/cm2 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@ with 2.5% Diclofenac patches.

Other Names:

ZetrOZ Ultrasound Device

Wearable Ultrasound Device

Long Duration Ultrasound

LITUS DeviceWearable

Long Duration Low-Intensity Device

Placebo Comparator: Placebo SAM Ultrasound Device and Diclofenac Patch

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.

Device: Placebo Sustained Acoustic Device with 0% Diclofenac Patch

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

Other Names:

ZetrOZ Ultrasound Device

Ultrasound Device

Long Duration Ultrasound

LITUS DeviceWearable

Long Duration Low-Intensity Device

Active Comparator: Over the Counter Arthritis Pain Gel

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

Drug: 1% Diclofenac Topical Gel

Topical pain-relief gel

Other Names:

Voltaren

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-
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time Frame: 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)