protocolSection identificationModule nctId: NCT06271746, orgStudyIdInfo id: TCH101, briefTitle: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Theranica, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment. Randomized, double-blind, sham-controlled, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: FibroNova (Active mode), interventions name: FibroNova (Sham mode), outcomesModule primaryOutcomes measure: 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), primaryOutcomes measure: Device safety (rate of adverse events and device related adverse events), secondaryOutcomes measure: Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score, secondaryOutcomes measure: Mean change in FIQR functionality sub-scale score, secondaryOutcomes measure: Mean change in FIQR pain item score, secondaryOutcomes measure: Mean change in Brief Pain Inventory (BPI) score, secondaryOutcomes measure: Improvement in patient global impression according to PGIC score, secondaryOutcomes measure: Mean reduction in functional disability 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), otherOutcomes measure: Improvement in quality of life, otherOutcomes measure: Improvement in sleep quality, otherOutcomes measure: Mean change in level of depression, otherOutcomes measure: Mean change in level of anxiety, otherOutcomes measure: Mean change in level of cognitive impairment, otherOutcomes measure: Mean change in level of cognitive presenteeism, otherOutcomes measure: Mean reduction of at least 30% in pain level, otherOutcomes measure: Rate of treatment tolerability, otherOutcomes measure: User experience, otherOutcomes measure: Patient Global Impression- change (PGI-C, otherOutcomes measure: Patient Global Impression- change (PGI-C)- mid study:, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Professionals, status: RECRUITING, city: Chesterfield, state: Missouri, zip: 63005, country: United States, contacts name: Shahmir Kahn, role: CONTACT, phone: 636-220-1200, email: skhan@clinicalresearchprofessionals.net, contacts name: Daniel Mattson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.66311, lon: -90.57707, locations facility: ClinVest Headlands Research, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Brittni kendrick, role: CONTACT, phone: 417-883-7889, email: brittni.kendrick@clinvest.com, contacts name: David True, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Gershon Pain Specialists, status: RECRUITING, city: Virginia Beach, state: Virginia, zip: 23454, country: United States, contacts name: Erika Dorman, role: CONTACT, phone: 757-496-2050, email: edorrman@gershonpain.com, contacts name: Steven Gershon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.85293, lon: -75.97799, locations facility: Tel Aviv Sourasky Medical Center, status: NOT_YET_RECRUITING, city: Tel Aviv, zip: 6423906, country: Israel, contacts name: Sara Pel, role: CONTACT, phone: +972-52-4266605, email: sarap@tlvmc.gov.ii, contacts name: Ori Elkayam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False