Using the FibroNova device to treat fibromyalgia
A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.
NA · Theranica · NCT06271746
This study is testing a new device called FibroNova to see if it can help people with fibromyalgia feel less pain and improve their overall symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Theranica (industry) |
| Locations | 4 sites (Chesterfield, Missouri and 3 other locations) |
| Trial ID | NCT06271746 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the FibroNova neuromodulation device in treating fibromyalgia, a chronic condition characterized by widespread pain and fatigue. The study employs Remote Electrical Neuromodulation (REN) technology, which delivers non-painful neurostimulation signals to activate the body's natural pain management system. Participants will be randomly assigned to receive either active treatment or a sham version of the device. The goal is to assess pain relief and overall improvement in symptoms among individuals with fibromyalgia.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 who meet the diagnostic criteria for fibromyalgia and have not previously used the FibroNova or Nerivio devices.
Not a fit: Patients with significant comorbidities, recent changes in pain medications, or those newly diagnosed with fibromyalgia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-pharmacological option for managing fibromyalgia symptoms, potentially improving patients' quality of life.
How similar studies have performed: Previous studies have shown that Remote Electrical Neuromodulation is safe and effective for pain relief, suggesting potential success for this approach in treating fibromyalgia.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chesterfield, Missouri and 3 other locations
- Clinical Research Professionals — Chesterfield, Missouri, United States (RECRUITING)
- ClinVest Headlands Research — Springfield, Missouri, United States (RECRUITING)
- Gershon Pain Specialists — Virginia Beach, Virginia, United States (RECRUITING)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Dagan Harris
- Email: daganh@theranica.com
- Phone: +97272 3909752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, fibromyalgia, Neuromodulation