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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 osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained Acoustic Device with 2.5% Diclofenac Patch | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Rating of Change (GROC) on a Scale (-7 to +7) | Subject-reported change in overall pain on a scale, -7 = worst, +7 = best. | Through study completion, average of 24 weeks. |
| Change in the Pain & Sleep Questionnaire (PSQ-3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George K. Lewis, Ph.D. | Contact | 888-202-9831 | george@zetroz.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Winkler, Ph.D. | James A. Haley Veterans Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A Haley Veterans Hospital | Recruiting | Tampa | Florida | 33511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408796 | Background | Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18. | |
| 33076955 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| 2.5% Diclofenac Patches | Drug | Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch. |
|
Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact
| Through study completion, average of 24 weeks. |
| Change in Depression Anxiety Stress Scale (DASS21) | Subject-reported measures of depression, anxiety, and stress on a scale of 0-3, 0 being not applicable, 1 meaning applicable to some degree, 2 meaning applicable often, and 3 meaning applicable most of the time. Questions are divided into three categories: depression, anxiety, and stress. | Through study completion, average of 24 weeks. |
| Best TM, Petterson S, Plancher K. Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management. J Orthop Surg Res. 2020 Oct 19;15(1):481. doi: 10.1186/s13018-020-01987-x. |
| 30326947 | Background | Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0. |
| 25788823 | Background | Langer MD, Levine V, Taggart R, Lewis GK, Hernandez L, Ortiz R. Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis. Proc IEEE Annu Northeast Bioeng Conf. 2014 Apr;2014:14789673. doi: 10.1109/NEBEC.2014.6972850. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |