Sustained Acoustic Medicine for Osteoarthritis Pain

Part of paid clinical trials in Tampa, Florida.

Sponsor
ZetrOZ, Inc.
Study ID
NCT05254574
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
35 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@ with 2.5% Diclofenac patches.
  • 2.5% Diclofenac Patches — DRUG
    Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

Study Details

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.

Key Dates

Start date
Feb 14, 2022
Status verified
Feb 2025
Primary completion
May 1, 2026
Completion
May 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
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 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.

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 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James A Haley Veterans HospitalTampaFlorida33511
Samuel Phillips, Ph.D.
[email protected]
813-558-3945

Find similar trials in Tampa, FL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
James A Haley Veterans Hospital· Tampa, FL

Related Studies