Vagus Nerve Stimulation in Fibromyalgia
CompletedNot applicableNCT06237595
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Comparative Study Between the Outcome of Noninvasive Vagus Nerve Stimulation and Medical Treatment in Fibromyalgia Patients
- Conditions
- Interventions
- Device: Vagus nerve stimulation
- Drug: Medical treatment
- Combination product: Combined vagus nerve stimulation and medical treatment
- Sponsor
- Kasr El Aini Hospital
- Start date
- 2023-09-30
- Primary completion
- 2025-02-15
- Sex
- Female
- Age range
- from 18 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- Egypt
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06237595