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

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
ZetrOZ, Inc.
Study ID
NCT06257537
Phase
PHASE2
Status
Recruiting
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Conditions

  • Arthritis
  • Osteo Arthritis Knee

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Accepted

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.
  • Sustained Acoustic Device with 0% Diclofenac Patch — DEVICE
    Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
  • 2.5% Diclofenac Patches — DRUG
    Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
  • SAM Patch — OTHER
    Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Feb 2025
Primary completion
Feb 1, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 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.
  • Active Comparator: 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 24 weeks combined with SAM patch (0% diclofenac).
  • Active Comparator: Diclofenac Patch
    Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.
  • Placebo Comparator: SAM Patch
    Patients wear 0% diclofenac patch for 4 hours at least 5 days a week for 24 weeks combined.

Primary Outcome Measure

Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline [ Time Frame: Through study completion, average of 24 weeks. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Orthopaedic FoundationStamfordConnecticut06905
Stephanie Petterson, MPT, Ph.D.
[email protected]
203-869-2002
ZetrOZ SystemsTrumbullConnecticut06611
George K Lewis, Ph.D.
[email protected]
888-202-9831
Cayuga Medical Center - Medical Pain ConsultantsDrydenNew York13053
Ralph Ortiz, DO
[email protected]
607-844-9979

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By research site
Orthopaedic Foundation· Stamford, CTZetrOZ Systems· Trumbull, CTCayuga Medical Center - Medical Pain Consultants· Dryden, NY

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