Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Study Overview
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Brief Summary
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The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of knee osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

Official Title
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Sustained Acoustic Medicine for Knee Osteoarthritis Pain

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Sustained Acoustic Device with 2.5% Diclofenac Patch
* Device: Placebo Sustained Acoustic Device with 0% Diclofenac Patch
* Drug: 1% Diclofenac Topical Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA Are between 35-80 years of age Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment Report that knee 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 knee 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. Is non-ambulatory (unable to walk). 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 replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months Are currently taking steroids 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: Quadruple


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;|
| Placebo Comparator: Placebo SAM Ultrasound Device and Diclofenac Patch<br>Patients receive placebo treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 0% diclofenac patch. | Device: Placebo Sustained Acoustic Device with 0% Diclofenac Patch<br>* Patients apply the placebo SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% Diclofenac patches.<br>* Other names: Long Duration Low-Intensity Device;|
| Active Comparator: Over the Counter Arthritis Pain 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). | Time Frame: 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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Continuous ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Joint Injury, Osteoarthritis