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Treatment with active FibroNova device for Fibromyalgia
Study Summary
This trial examines a new technology called Remote Electrical Neuromodulation (REN) for treating fibromyalgia pain. REN uses non-painful signals to activate the body's pain management system
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there any available openings for patients to participate in this study?
"Information from clinicaltrials.gov indicates that recruitment for this specific trial is currently closed. Originally listed on March 4, 2024, with the last update made on February 14, 2024. Despite this trial no longer accepting participants, there are numerous other studies actively seeking candidates at present."
Does this study include individuals who are 55 years old and above?
"Individuals aged 18 to 70 years old are eligible for participation in this clinical trial."
What are the main goals that this clinical trial aims to achieve?
"The primary aim of this trial, with an assessment period spanning approximately 16 weeks, is to assess device safety by evaluating the occurrence rate of adverse events and device-related adverse events. Secondary goals encompass determining the mean alteration in the Revised Fibromyalgia Impact Questionnaire (FIQR) total score from baseline conclusion (week 4) to intervention conclusion (week 16), enhancing patient global impression as per PGIC score at week 12's completion, and analyzing changes in FIQR pain item scores over the same time frame."
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What portion of applicants met pre-screening criteria?
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