NCT07153900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

August 26, 2025

Last Update Submit

December 30, 2025

Conditions

Safety and Tolerability in Healthy Subjects

Keywords

muscle stimulationtopical heating

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of participants with a device-related adverse event

    7 days

  • Number of patients reporting therapy tolerability

    7 days

Study Arms (2)

Hands-on

ACTIVE COMPARATOR

Treatment delivered by therapist utilizing multipolar electrode

Device: Treatment with BACK4 System

Hands-free

ACTIVE COMPARATOR

Treatment delivered utilizing fixed pads

Device: Treatment with BACK4 System

Interventions

Treatment with BACK4 SystemDEVICE

Use of combined RF and EMS therapy with BACK4 Device

Hands-freeHands-on

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults 22-55 years old
  • Able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RORE Method

Birmingham, Michigan, 48009, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 4, 2025

Study Start

October 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 25, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)