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

NCT05050448 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: HF-01-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Keywords

Non-Steroidal Anti-Inflammatory Drugs; Sustained Acoustic Medication; Low-Intensity Continuous Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.

  8 weeks

• Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline

  WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.

  8 weeks

Study Arms (3)

SAM Ultrasound Device and Diclofenac Patch

EXPERIMENTAL

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

SAM2 Ultrasound Device and Diclofenac Patch

EXPERIMENTAL

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.

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

Topical Pain-Relief Gel

PLACEBO COMPARATOR

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

Drug: 1% Diclofenac Topical Gel

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patch 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.

Also known as: ZetrOZ Ultrasound Device, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device, Long Duration Low-Intensity Device

SAM Ultrasound Device and Diclofenac Patch; SAM2 Ultrasound Device and Diclofenac Patch

1% Diclofenac Topical Gel DRUG

Topical pain-relief gel

Also known as: Voltaren

Topical Pain-Relief Gel

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (3)

Orthopaedic Foundation

Stamford, Connecticut, 06905, United States

Location

ZetrOZ Systems

Trumbull, Connecticut, 06611, United States

Location

Cayuga Medical Center - Medical Pain Consultants

Dryden, New York, 13053, United States

Location

Related Links

• Class II Medical Device

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Ralph Ortiz
• Organization: Medical Pain Consultants

rodoc@cnymail.com

607-844-9979

Study Officials

• George K Lewis, Ph.D.

  ZetrOZ Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)