Safety and Tolerability in Healthy Subjects
Conditions
Keywords
muscle stimulation, topical heating
Brief summary
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.
Interventions
DEVICETreatment with BACK4 System
Use of combined RF and EMS therapy with BACK4 Device
Sponsors
SWIMS America Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 22-55 years old * Able to provide written informed consent
Exclusion criteria
* Injury within the past 30 days * Cancer or cancerous lesions in the treatment area * Skin disorders (e.g., eczema, shingles), skin burns, or open wounds * Coagulation disorders, phlebitis, or thrombophlebitis * Insensitivity to heat * Local insensitivity to pain and/or touch * Fever, bacterial infection, infectious disease, or tuberculosis * Severe hypertension or hypotension * Electrical implants (e.g., pacemaker, insulin pump, neurostimulator) * History of seizures or recent surgery * Known hypersensitivity to device materials * Pregnant or breastfeeding women * Participation in another clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a reported Adverse Event | 7 days | Characterize the number of adverse events for the combined use of RF and EMS with the BACK4 device across the device's intended configurations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a device-related adverse event | 7 days | 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 |
| Number of patients reporting therapy tolerability | 7 days | 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) |
Countries
United States
Outcome results
None listed