CompletedNot Applicable

Vagus Nerve Stimulation in Fibromyalgia

Egypt87 participantsStarted 2023-09-30

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analogue scale 0-10

Timeframe: 0,1,2 months

Symptom severity scale score

Timeframe: 0,1,2 months

Widespread pain index

Timeframe: 0,1,2 months

Fibromyalgia severity scale

Timeframe: 0,1,2 months

Fibromyalgia impact questionnaire

Timeframe: 0,1,2 months

Trial details

NCT IDNCT06237595

SponsorKasr El Aini Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-15

View on ClinicalTrials.gov More Fibromyalgia trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.