Clinical trial NCT06237595: Vagus Nerve Stimulation in Fibromyalgia
Official title: Comparative Study Between the Outcome of Noninvasive Vagus Nerve Stimulation and Medical Treatment in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: vagus nerve stimulation
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Visual analogue scale 0-10
timeFrame: 2 months
measure: Symptom severity scale score
timeFrame: 2 months
measure: Widespread pain index
timeFrame: 2 months
measure: Fibromyalgia severity scale
timeFrame: 2 months
Secondary outcomes:
measure: Beck anxiety scale
timeFrame: 2 months
measure: Beck depression inventory
timeFrame: 2 months
measure: Pittsburgh sleep quality index
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Elainy Hospital
Study officials:
affiliation: kasr Elainy Hospital
name: Hadeel A Elegily, DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095.
citation: Kutlu N, Ozden AV, Alptekin HK, Alptekin JO. The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome. Biomed Res Int. 2020 Feb 28;2020:8656218. doi: 10.1155/2020/8656218. eCollection 2020.
citation: Drewes AM, Brock C, Rasmussen SE, Moller HJ, Brock B, Deleuran BW, Farmer AD, Pfeiffer-Jensen M. Short-term transcutaneous non-invasive vagus nerve stimulation may reduce disease activity and pro-inflammatory cytokines in rheumatoid arthritis: results of a pilot study. Scand J Rheumatol. 2021 Jan;50(1):20-27. doi: 10.1080/03009742.2020.1764617. Epub 2020 Oct 13.
citation: Bonaz B, Picq C, Sinniger V, Mayol JF, Clarencon D. Vagus nerve stimulation: from epilepsy to the cholinergic anti-inflammatory pathway. Neurogastroenterol Motil. 2013 Mar;25(3):208-21. doi: 10.1111/nmo.12076. Epub 2013 Jan 29.
citation: Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.