Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-10-01
2025-12-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hands-on
Treatment delivered by therapist utilizing multipolar electrode
Treatment with BACK4 System
Use of combined RF and EMS therapy with BACK4 Device
Hands-free
Treatment delivered utilizing fixed pads
Treatment with BACK4 System
Use of combined RF and EMS therapy with BACK4 Device
Interventions
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Treatment with BACK4 System
Use of combined RF and EMS therapy with BACK4 Device
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
Exclusion Criteria
* 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
22 Years
55 Years
ALL
Yes
Sponsors
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SWIMS America Corp.
INDUSTRY
Responsible Party
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Locations
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RORE Method
Birmingham, Michigan, United States
Countries
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Other Identifiers
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SF-B4-001
Identifier Type: -
Identifier Source: org_study_id