Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
ZetrOZ, Inc.
Study ID
NCT07515872
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Arthritis
  • Osteo Arthritis of the Knee

Eligibility Criteria

Sex
ALL
Age
65 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.
  • Intra articular injection — DRUG
    Single intraarticular injection of 1cc 40mg/cc triamcinolone acetonide

Study Details

The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
240 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 12 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 12 weeks combined with SAM patch (0% diclofenac).
  • Active Comparator: Corticosteroid Injection
    Patients receive treatment of single intraarticular corticosteroid injection (triamcinolone acetonide)

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 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orthopaedic FoundationStamfordConnecticut06905
Stephanie Petterson, PhD, MPT
[email protected]
203-869-2002
Cayuga Medical Center - Medical Pain ConsultantsDrydenNew York13053
Ralph Ortiz, DO, MPH
[email protected]
607-844-9979

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

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