Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

NCT ID: NCT05050448

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sustained Acoustic Device with 2.5% Diclofenac Patch

Intervention Type: DEVICE

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.

SAM2 Ultrasound Device and Diclofenac Patch

Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour 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.

Group Type: EXPERIMENTAL

Sustained Acoustic Device with 2.5% Diclofenac Patch

Intervention Type: DEVICE

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.

Topical Pain-Relief Gel

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

Group Type: PLACEBO_COMPARATOR

1% Diclofenac Topical Gel

Intervention Type: DRUG

Topical pain-relief gel

Interventions

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.

Intervention Type: DEVICE

1% Diclofenac Topical Gel

Topical pain-relief gel

Intervention Type: DRUG

Other Intervention Names

ZetrOZ Ultrasound Device; Wearable Ultrasound Device; Long Duration Ultrasound; LITUS Device; Long Duration Low-Intensity Device; Voltaren

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
• 35-80 years of age
• Report a frequent pain score between 4-7 (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 gel provided to the subject at the initiation of the study
• Deemed appropriate by their physician or by the study site physician to participate
• 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 initiate use of opioid and/or non-opioid analgesic medications
• Willing to discontinue any other interventional treatment modalities on the knee during the study period

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
• Is non-ambulatory (unable to walk)
• Is pregnant
• Is a prisoner
• 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 known neuropathy
• Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
• 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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZetrOZ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George K Lewis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

ZetrOZ Systems

Locations

Orthopaedic Foundation

Stamford, Connecticut, United States

ZetrOZ Systems

Trumbull, Connecticut, United States

Cayuga Medical Center - Medical Pain Consultants

Dryden, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.samrecover.com

Class II Medical Device

Other Identifiers

HF-01-2021

Identifier Type: -

Identifier Source: org_study_id