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Neuromodulation Device

Treatment with active FibroNova device for Fibromyalgia

N/A

Recruiting

Research Sponsored by Theranica

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient age is 18-70

Possesses the basic cognitive and motor skills needed to operate his/her own smartphone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

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

Who is the study for?

This trial is for individuals with fibromyalgia or myofascial pain syndrome, experiencing widespread body pain, tenderness, and fatigue. Participants should be seeking non-pharmacological treatment options.Check my eligibility

What is being tested?

The study tests the FibroNova device's safety and effectiveness in treating fibromyalgia symptoms. It uses Remote Electrical Neuromodulation to potentially ease pain by activating the body's own pain management system.See study design

What are the potential side effects?

While specific side effects are not listed, similar neuromodulation devices can cause mild skin irritation at the site of application or a temporary increase in muscle tension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I can use my smartphone by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Device safety (rate of adverse events and device related adverse events)

Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4)

Secondary outcome measures

Improvement in patient global impression according to PGIC score

Mean change in Brief Pain Inventory (BPI) score

Mean change in FIQR functionality sub-scale score

+3 more

Other outcome measures

Improvement in quality of life

Improvement in sleep quality

Mean change in level of anxiety

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment with active FibroNova deviceActive Control1 Intervention

Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.

Group II: Treatment with Sham FibroNova devicePlacebo Group1 Intervention

Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

TheranicaLead Sponsor

19 Previous Clinical Trials

40,772 Total Patients Enrolled

Daniel Clauw, MDStudy ChairUniversity of Michigan

3 Previous Clinical Trials

952 Total Patients Enrolled

1 Trials studying Fibromyalgia

22 Patients Enrolled for Fibromyalgia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI