BACK4 System for Safety Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to ensure the safety of a new treatment device called the BACK4 System, which combines radiofrequency (RF) and electrical muscle stimulation (EMS). Healthy volunteers will receive three treatments over one week to observe their body's reactions. The trial compares two methods: one where a therapist applies the treatment and another using fixed pads. Individuals who have been healthy without recent injuries and can feel heat and touch might be suitable for this trial. As an unphased trial, participants can contribute to groundbreaking research and be among the first to experience this innovative treatment approach.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the BACK4 System is safe for healthy volunteers?
Research has shown that the BACK4 System, which combines radio waves and electrical muscle stimulation, is safe for healthy volunteers. The hands-on version of this device uses advanced technology that has been safely and effectively applied in other contexts, indicating it is generally well-tolerated.
For the hands-free version, tests confirmed its electrical safety and effectiveness. These tests verified that the device meets safety standards, supporting its safe use in people.
Overall, both versions of the BACK4 System demonstrate promising safety features based on their design and previous evaluations.12345Why are researchers excited about this trial?
The BACK4 System is unique because it offers two distinct methods for delivering treatment, potentially enhancing effectiveness and convenience for patients with back pain. The "Hands-on" approach involves a therapist using a multipolar electrode, which may allow for more targeted and personalized therapy. Meanwhile, the "Hands-free" method uses fixed pads, providing a more convenient and possibly less time-consuming option for patients who prefer or require minimal therapist interaction. Researchers are excited about these approaches because they could offer more tailored and flexible treatment options compared to current standards like physical therapy and medication.
What evidence suggests that the BACK4 System is effective for safety evaluation?
This trial will compare the BACK4 System's hands-on and hands-free treatment methods. Research has shown that hands-free treatments, such as the BACK4 System's method, often reduce pain more effectively over the long term than hands-on methods. These hands-free techniques use advanced technology to reach deeper tissues and aid recovery. While hands-on treatments, involving direct touch, have proven beneficial in many physical therapy settings, their long-term effectiveness remains less certain. Both methods aim to relieve pain and improve function, but the hands-free method might offer more lasting results.36789
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 22-55 who can consent to participate. It's not suitable for those with recent injuries, heat insensitivity, allergies to device materials, current pregnancy or breastfeeding, participation in another trial within the last month, certain skin conditions or wounds, pain insensitivity, electrical implants like pacemakers, cancer in the treatment area, blood clotting issues, infections including tuberculosis or feverish illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 treatments of increasing intensity with the BACK4 device over a one week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BACK4 System
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWIMS America Corp.
Lead Sponsor