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Treatment of Fibromyalgia With the FibroNova Neuromodulation Device

NCT06271746 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-04-11

No results posted yet for this study

Summary

Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.

Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.

Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.

The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms.

Conditions

  • Fibromyalgia

Interventions

DEVICE

FibroNova (Active mode)

FibroNova neurostimulator of conditional pain modulation (CPM)

DEVICE

FibroNova (Sham mode)

FibroNova neurostimulator with an electrical output not intended for neurostimulation

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Daniel Clauw, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2025-03-01
Completion
2025-06-01
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271746 on ClinicalTrials.gov