A Prospective, Randomized, Double-blind, Sham-controlled Clinical Study Assessing the Safety and Efficacy of FibroNova for the Treatment of Fibromyalgia.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Clinical Research Professionals
RECRUITING
Chesterfield
ClinVest Headlands Research
RECRUITING
Springfield
Virginia
Gershon Pain Specialists
RECRUITING
Virginia Beach
Other Locations
Israel
Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Contact Information
Primary
Dagan Harris
daganh@theranica.com
+97272 3909752
Backup
Liron Rabani
Lironr@theranica.com
+97272 3909752
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 170
Treatments
Active_comparator: Treatment with active FibroNova device
Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.
Placebo_comparator: Treatment with Sham FibroNova device
Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.
Related Therapeutic Areas
Sponsors
Leads: Theranica

This content was sourced from clinicaltrials.gov