FibroNovaTreatment of Fibromyalgia With the FibroNova Neuromodulation Device

Inclusion Criteria:

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

Exclusion Criteria:

1. Change in prescribed medications for pain and/or fibromyalgia in the two months prior to enrolment.
2. Pregnant or lactating.
3. 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).
4. Newly diagnosed with fibromyalgia (under six months).
5. 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).
6. Known uncontrolled epilepsy.
7. Active substance use disorder that could interfere with study participation.
8. Use of opioids during the 2 months prior to enrolment.
9. Has undergone nerve block (occipital or other) during the 2 months prior to enrolment.
10. Patients with severe depression, and/or suicidality
11. Is participating in any other clinical study.
12. Use of a neuromodulation device specifically indicated for FM ( e.g.Quell ) currently or in the 2 months prior to enrolment.