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

NCT06257537 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: KP-01-2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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 a 24-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.

Conditions

Osteo Arthritis Knee; Arthritis

Keywords

Low-Intensity Ultrasound; Drug Delivery; Sonophoresis; Transdermal Drug Delivery; 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.

  Through study completion, average of 24 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).

  Through study completion, average of 24 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 (4)

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 24 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.

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

SAM Ultrasound Device and SAM Patch

ACTIVE COMPARATOR

Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 24 weeks combined with SAM patch (0% diclofenac).

Device: Sustained Acoustic Device with 0% Diclofenac Patch

Diclofenac Patch

ACTIVE COMPARATOR

Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Drug: 2.5% Diclofenac Patches

SAM Patch

PLACEBO COMPARATOR

Patients wear 0% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Other: SAM Patch

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\^2 with 2.5% Diclofenac patches.

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

SAM Ultrasound Device and Diclofenac Patch

Sustained Acoustic Device with 0% Diclofenac Patch DEVICE

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

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

SAM Ultrasound Device and SAM Patch

2.5% Diclofenac Patches DRUG

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

Diclofenac Patch

SAM Patch OTHER

Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.

SAM Patch

Eligibility Criteria

• Age: 50 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 OA (OARSI atlas grades 1-2)
• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
• Are between 50-85 years of age
• Report a frequent pain score between 4-7 (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 ultrasound gel 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 use of 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).

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.
• 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 any contraindication to radiograph.

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (3)

Orthopaedic Foundation

Stamford, Connecticut, 06905, United States

RECRUITING

ZetrOZ Systems

Trumbull, Connecticut, 06611, United States

RECRUITING

Cayuga Medical Center - Medical Pain Consultants

Dryden, New York, 13053, United States

RECRUITING

Related Links

• Class II Medical Device

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• George K Lewis, Ph.D.

  ZetrOZ Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George K Lewis, Ph.D.

CONTACT

8882029831; george@zetroz.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 14, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 28, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)