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NCT05254574 | RECRUITING | Osteoarthritis

Sustained Acoustic Medicine for Osteoarthritis Pain
Sponsor:

ZetrOZ, Inc.

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.

Condition or disease

Osteoarthritis

Intervention/treatment

Sustained Acoustic Device with 2.5% Diclofenac Patch

2.5% Diclofenac Patches

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Sustained Acoustic Medicine for Osteoarthritis Pain
Actual Study Start Date : 2022-02-14
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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).
Exclusion Criteria
  • * 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)
Sustained Acoustic Medicine for Osteoarthritis Pain

Location Details

NCT05254574

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

James A Haley Veterans Hospital

Tampa, Florida, United States, 33511