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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Sustained Acoustic Device with 2.5% Diclofenac Patch
* Drug: 1% Diclofenac Topical Gel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAM Ultrasound Device and Diclofenac Patch<br>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. | Device: Sustained Acoustic Device with 2.5% Diclofenac Patch<br>* 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.<br>* Other names: Long Duration Low-Intensity Device;|
| Experimental: SAM2 Ultrasound Device and Diclofenac Patch<br>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. | Device: Sustained Acoustic Device with 2.5% Diclofenac Patch<br>* 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.<br>* Other names: Long Duration Low-Intensity Device;|
| Placebo Comparator: Topical Pain-Relief Gel<br>Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. | Drug: 1% Diclofenac Topical Gel<br>* Topical pain-relief gel<br>* Other names: Voltaren;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | Change in the self described pain units on a scale by patient at baseline and post- | Through study completion, average of 8 weeks | 
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). | Through study completion, average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound