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OpenTrials
Completed

NCT Number: NCT07153900

BACK4 Safety Evaluation

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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Key information

Conditions

Safety and Tolerability in Healthy Subjects

Age range

22 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RORE Method

Birmingham, Michigan, 48009, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with BACK4 System

Device

Use of combined RF and EMS therapy with BACK4 Device

Primary outcomes

  1. Number of participants with a reported Adverse Event

    Time frame: 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 outcomes

  1. Number of participants with a device-related adverse event

    Time frame: 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

  2. Number of patients reporting therapy tolerability

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

SWIMS America Corp.

Industry

Registry information

Official study title

Safety Evaluation of BACK4 Device

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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