Vagus Nerve Stimulation in Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Vagus nerve stimulation is thought to reduce sympathetic nerve outflow and so can improve sympathetic hyperactivity in fibromyalgia patients. We aimed in the current study, to evaluate the effect of the cervical transcutaneous vagus nerve stimulation in comparison to conventional medical treatment in Egyptian fibromyalgia patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

NCT06009159

Fibromyalgia

RECRUITING NA

Vagus Nerve Stimulation for Treating Adults With Severe Fibromyalgia

NCT00294281

Fibromyalgia

COMPLETED PHASE1

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia- Double-blind, Sham-controlled Randomized Clinical Trial

NCT06912334

Transcutaneous Vagus Nerve Stimulation on Fibromyalgia

RECRUITING NA

Auricular Vagus Nerve Stimulation For Fibromyalgia Syndrome

NCT04260906

Fibromyalgia Myofascial Pain Syndrome

COMPLETED NA

taVNS Treatment for Fibromyalgia

NCT04777500

Fibromyalgia

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the current study, the investigators will investigate the effects of transcutaneous cervical vagus stimulation (t-VNS) on 90 Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 American College of Rheumatology (ACR) fibromyalgia diagnostic criteria.

The ninety patients will be divided into 3 groups:

Group A: will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a transcutaneous electrical nerve stimulation (TENS) device, using a small self-adhesive surface electrodes (1 cm diameter). The electrodes will be positioned on the surface of the neck that corresponds to the position of the left cervical branch of the vagus nerve, using a biphasic, asymmetrical waveform with a pulse duration that is less than 250 microseconds and a frequency of 20 hertz. Intensity is adjusted according to the sensory threshold level of each patient, each session lasts for 30 minutes. All patients will receive 3 sessions per week for a total of 12 sessions, The sessions will be carried on at Department of Rheumatology and Rehabilitation, Cairo University Hospital.

Group B will receive cervical t-VNS in the same protocol like group A, in addition to medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

Group C will receive medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

All the patients in the 3 groups will be advised to stop any medication one week before intervention, and to report if any kind of medications is taken during the study period. They will be assessed before starting intervention (at baseline), just after completion of intervention (at one month), and one month after stoppage of intervention (at 2 months).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 Vagus nerve stimulation

The first group will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a TENS device, using a small self-adhesive surface electrodes (1 cm diameter). The electrodes will be positioned on the surface of the neck that corresponds to the position of the left cervical branch of the vagus nerve, over the carotid pulse just medial to the sternocleidomastoid muscle (Molero-Chamizo et al., 2022) using a biphasic, asymmetrical waveform with a pulse duration that is less than 250 microseconds and a frequency of 20 hertz. Intensity is adjusted according to the sensory threshold level of each patient, each session lasts for 30 minutes (Kutlu et al., 2020). All patients will receive 3 sessions per week for a total of 12 sessions, The sessions will be carried on at Department of Rheumatology and Rehabilitation, Cairo University Hospital

Group Type ACTIVE_COMPARATOR

Vagus nerve stimulation

Intervention Type DEVICE

Electrical stimulation of the vagus nerve.

2 Medical treatment

This group will receive medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type DRUG

Medical treatment for fibromyalgia patients

3 Combined vagus nerve stimulation and medical treatment

This group will receive cervical t-VNS in the same protocol like the vagus nerve stimulation group, in addition to medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

Group Type ACTIVE_COMPARATOR

Combined vagus nerve stimulation and medical treatment

Intervention Type COMBINATION_PRODUCT

Combination of the two interventions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vagus nerve stimulation

Electrical stimulation of the vagus nerve.

Intervention Type DEVICE

Medical treatment

Medical treatment for fibromyalgia patients

Intervention Type DRUG

Combined vagus nerve stimulation and medical treatment

Combination of the two interventions

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study.

Exclusion Criteria

* \- Pregnant, and postmenopausal women.
* Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease).
* Cancer diagnosis within the preceding 5 years.
* Planned surgery.
* Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain.
* Electrocardiogram (ECG) abnormalities.
* History of Electroconvulsive therapy (ECT).
* Symptomatic orthostatic hypotension, or history of recurrent vagal syncope.
* History of vagotomy.
* Uncontrolled hypertension or hypotension.
* Documented sleep apnea.
* Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No