Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

Phase 1

Completed

Interventions: Device: Sustained Acoustic Device with 2.5% Diclofenac Patch
Drug: 1% Diclofenac Topical Gel

Brief Summary: The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.

Recruitment & Eligibility

Inclusion Criteria

Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
35-80 years of age
Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
Report that knee pain negatively affects quality of life
Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
Deemed appropriate by their physician or by the study site physician to participate
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 initiate use of opioid and/or non-opioid analgesic medications
Willing to discontinue any other interventional treatment modalities on the knee during the study period

Exclusion Criteria

Cannot successfully demonstrate the ability to put on and take off the device
Display 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
Have severe OA or have little to no cartilage in the knee
Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
Is non-ambulatory (unable to walk)
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 known neuropathy
Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
Currently taking steroids
Have contraindication to radiograph
Have a secondary cause of arthritis (metabolic or inflammatory)

Arm && Interventions

Group	Intervention	Description
SAM Ultrasound Device and Diclofenac Patch	Sustained Acoustic Device with 2.5% 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.
SAM2 Ultrasound Device and Diclofenac Patch	Sustained Acoustic Device with 2.5% Diclofenac Patch	Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour 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.
Topical Pain-Relief Gel	1% Diclofenac Topical Gel	Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline	8 weeks	Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline	8 weeks	WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.

Secondary Outcome Measures

Name	Time	Method

Locations (3): ZetrOZ Systems
🇺🇸
Trumbull, Connecticut, United States
Cayuga Medical Center - Medical Pain Consultants
🇺🇸
Dryden, New York, United States
Orthopaedic Foundation
🇺🇸
Stamford, Connecticut, United States