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First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Recipient of Hypersound Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF-PNS | Device | Noninvasive peripheral nerve stimulator using interferential multi source radio frequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Visual Analog Score Improvement of 50% | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Oswestry disability index improvement of greater than 50% | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Dickman, MS | Contact | (480) 278-9200 | timd@hypersoundmedical.com | |
| Gobi Paramanandnam, MD, MHSM | Contact | (480) 889-0180 | gkparam@gmail.com |
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Staff and research team aren't supported to persist the data
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