Sustained Acoustic Medicine for Osteoarthritis Pain

NCT05254574 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: OA-01-2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

Conditions

Osteoarthritis

Keywords

Continuous ultrasound; Sustained Acoustic Medicine; Musculoskeletal Injuries; Low Intensity Continuous Ultrasound; Pain; Joint Injury; Osteoarthritis

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-

  Through study completion, average of 8 weeks

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

  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).

  Time Frame: Through study completion, average of 8 weeks

Secondary Outcomes (3)

• Change in Global Rating of Change (GROC) on a Scale (-7 to +7)

  Through study completion, average of 24 weeks.

• Change in the Pain & Sleep Questionnaire (PSQ-3)

  Through study completion, average of 24 weeks.

• Change in Depression Anxiety Stress Scale (DASS21)

  Through study completion, average of 24 weeks.

Study Arms (1)

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; Drug: 2.5% Diclofenac Patches

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 DeviceWearable, Long Duration Low-Intensity Device

SAM Ultrasound Device and Diclofenac Patch

2.5% Diclofenac Patches DRUG

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

SAM Ultrasound Device and Diclofenac Patch

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
• Are between 35-85 years of age
• Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
• Report that knee, shoulder, elbow, ankle, hip, or spine 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 treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

You may not qualify if:

• 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.
• 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, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
• Requires oxygen support
• Has an allergy to aspirin or other NSAIDs
• Have a secondary cause of arthritis (metabolic or inflammatory)

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (1)

James A Haley Veterans Hospital

Tampa, Florida, 33511, United States

RECRUITING

Related Publications (4)

• Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.

  PMID: 33408796 BACKGROUND

• Best TM, Petterson S, Plancher K. Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management. J Orthop Surg Res. 2020 Oct 19;15(1):481. doi: 10.1186/s13018-020-01987-x.

  PMID: 33076955 BACKGROUND

• Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.

  PMID: 30326947 BACKGROUND

• Langer MD, Levine V, Taggart R, Lewis GK, Hernandez L, Ortiz R. Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. Proc IEEE Annu Northeast Bioeng Conf. 2014 Apr;2014:14789673. doi: 10.1109/NEBEC.2014.6972850.

  PMID: 25788823 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Winkler, Ph.D.

  James A. Haley Veterans Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George K. Lewis, Ph.D.

CONTACT

888-202-9831; george@zetroz.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: February 14, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)