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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.
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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. |
|
| SAM2 Ultrasound Device and Diclofenac Patch | Experimental | 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 | Placebo Comparator | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. |
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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-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain. | 8 weeks |
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George K Lewis, Ph.D. | ZetrOZ Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Foundation | Stamford | Connecticut | 06905 | United States | ||
| ZetrOZ Systems |
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| Label | URL |
|---|---|
| Class II Medical Device | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAM Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2021 |
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| 1% Diclofenac Topical Gel | Drug | Topical pain-relief gel |
|
|
| Trumbull |
| Connecticut |
| 06611 |
| United States |
| Cayuga Medical Center - Medical Pain Consultants | Dryden | New York | 13053 | United States |
| FG001 | SAM2 Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. |
| FG002 | Topical Pain-Relief Gel | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. 1% Diclofenac Topical Gel: Topical pain-relief gel |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAM Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. |
| BG001 | SAM2 Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. |
| BG002 | Topical Pain-Relief Gel | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. 1% Diclofenac Topical Gel: Topical pain-relief gel |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
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| ||||||||||||||||||||||||||||||||
| Primary | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAM Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | SAM2 Ultrasound Device and 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. Sustained Acoustic Device with 2.5% Diclofenac Patch: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Topical Pain-Relief Gel | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. 1% Diclofenac Topical Gel: Topical pain-relief gel | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralph Ortiz | Medical Pain Consultants | 607-844-9979 | rodoc@cnymail.com |
| Apr 7, 2025 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| OG002 | Topical Pain-Relief Gel | Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks. 1% Diclofenac Topical Gel: Topical pain-relief gel |
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