Sustained Acoustic Medicine for Osteoarthritis Pain

ZetrOZ

Status and phase: Enrolling; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: 2.5% Diclofenac Patches; Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT05254574

OA-01-2022

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

SAM Ultrasound Device and Diclofenac Patch

Experimental group

Description:

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.

Treatment:

Device: Sustained Acoustic Device with 2.5% Diclofenac Patch

Drug: 2.5% Diclofenac Patches