NCT06271746

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 11, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 14, 2024

Last Update Submit

April 9, 2024

Conditions

Fibromyalgia

Keywords

fibromyalgiaNeuromodulation

Outcome Measures

Primary Outcomes (2)

  • 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)

    Mean change, from the last two weeks (weeks 3-4) of the baseline phase to the last two weeks (weeks 15-16) of the intervention phase, in the 2-week average of daily self-reported pain severity scores on NRS (0 to 10) that is based on the FIQR pain item.

    16 weeks

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

    The incidence of adverse events in general and by seriousness, severity and association to the device.

    28 weeks

Secondary Outcomes (6)

  • Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score

    16 weeks

  • Mean change in FIQR functionality sub-scale score

    16 weeks

  • Mean change in FIQR pain item score

    16 weeks

  • Mean change in Brief Pain Inventory (BPI) score

    16 weeks

  • Improvement in patient global impression according to PGIC score

    16 weeks

  • +1 more secondary outcomes

Other Outcomes (11)

  • Improvement in quality of life

    16 weeks

  • Improvement in sleep quality

    16 weeks

  • Mean change in level of depression

    16 weeks

  • +8 more other outcomes

Study Arms (2)

Treatment with active FibroNova device

ACTIVE COMPARATOR

Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.

Device: FibroNova (Active mode)

Treatment with Sham FibroNova device

PLACEBO COMPARATOR

Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.

Device: FibroNova (Sham mode)

Interventions

FibroNova (Active mode)DEVICE

FibroNova neurostimulator of conditional pain modulation (CPM)

Treatment with active FibroNova device
FibroNova (Sham mode)DEVICE

FibroNova neurostimulator with an electrical output not intended for neurostimulation

Treatment with Sham FibroNova device

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

RECRUITING

ClinVest Headlands Research

Springfield, Missouri, 65807, United States

RECRUITING

Gershon Pain Specialists

Virginia Beach, Virginia, 23454, United States

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Daniel Clauw, MD

    University of Michigan

    STUDY CHAIR

Central Study Contacts

Dagan Harris

CONTACT

+97272 3909752daganh@theranica.com

Liron Rabani

CONTACT

+97272 3909752Lironr@theranica.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment. Randomized, double-blind, sham-controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 22, 2024

Study Start

March 4, 2024

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

April 11, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)US(3)