Treatment of Fibromyalgia With the FibroNova Neuromodulation Device - Trial NCT06271746

Timeline & Enrollment

Primary Outcome

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

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.

ICD-10 Classifications