Treatment of Fibromyalgia With the FibroNova Neuromodulation Device

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT06271746

Run by

Theranica

People needed

170

Starts

2024-03-04

Expected to finish

2025-06-01

Last updated by the study team

2024-04-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient age is 18-70.
• Meets ACR 2010 Diagnostic Criteria for FM.
• Naïve to Nerivio and to FibroNova devices.
• Possesses the basic cognitive and motor skills needed to operate his/her own smartphone.
• Must be able and willing to comply with the protocol.
• Must be able and willing to provide written informed consent.

You may not qualify if…

• Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
• Pregnant or lactating.
• Has other significant comorbidities or pain problem(s) or undergoing specific therapies that in the opinion of the investigator may confound the study assessments.(e.g. active inflammatory joint disease, including spondyloarthropathy, or active malignancy, excluding Basal cell carcinoma).
• Newly diagnosed with fibromyalgia (under six months).
• Is currently implanted with an electrical and/or neurostimulation device (e.g., cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator bladder stimulator or Occipital nerve stimulator).
• Known uncontrolled epilepsy.
• Active substance use disorder that could interfere with study participation.
• Use of opioids during the 2 months prior to enrolment.
• Has undergone nerve block (occipital or other) during the 2 months prior to enrolment.
• Patients with severe depression, and/or suicidality
• Is participating in any other clinical study.
• Use of a neuromodulation device specifically indicated for FM ( e.g.Quell ) currently or in the 2 months prior to enrolment.

Where it is running

• Clinical Research Professionals — Chesterfield, Missouri, United States (enrolling)
• ClinVest Headlands Research — Springfield, Missouri, United States (enrolling)
• Gershon Pain Specialists — Virginia Beach, Virginia, United States (enrolling)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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