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

NCT ID: NCT05882812

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-03
• Study Completion Date: 2024-02-22

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.

Conditions

Osteo Arthritis Knee; Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

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/cm\^2 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\^2 with 2.5% Diclofenac patches.

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).

Group Type: ACTIVE_COMPARATOR

Sustained Acoustic Device with 0% Diclofenac Patch

Intervention Type: DEVICE

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

Diclofenac Patch

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

Group Type: ACTIVE_COMPARATOR

2.5% Diclofenac Patches

Intervention Type: DRUG

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

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\^2 with 2.5% Diclofenac patches.

Intervention Type: DEVICE

Sustained Acoustic Device with 0% Diclofenac Patch

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

Intervention Type: DEVICE

2.5% Diclofenac Patches

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

Intervention Type: DRUG

Other Intervention Names

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

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)

• 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

KP-01-2022

Identifier Type: -

Identifier Source: org_study_id