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To characterize the safety of combined RF and EMS therapies with the BACK4 device in healthy volunteers. Subjects will receive 3 treatments of increasing intensity over a one week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hands-on | Active Comparator | Treatment delivered by therapist utilizing multipolar electrode |
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| Hands-free | Active Comparator | Treatment delivered utilizing fixed pads |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BACK4 System | Device | Use of combined RF and EMS therapy with BACK4 Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a reported Adverse Event | Characterize the number of adverse events for the combined use of RF and EMS with the BACK4 device across the device's intended configurations | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a device-related adverse event | Characterize the number of device-related adverse events for the combined use of RF and EMS in terms of with the BACK4 device across the device's intended configurations | 7 days |
| Number of patients reporting therapy tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RORE Method | Birmingham | Michigan | 48009 | United States |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Therapy tolerability assessment will be ascertained by the subject using a 5-point scale (1=very uncomfortable, 2=somewhat uncomfortable, 3=neutral, 4=somewhat comfortable, 5=very comfortable) |
| 7 days |