Vagus Nerve Stimulation in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Comparative Study Between the Outcome of Noninvasive Vagus Nerve Stimulation and Medical Treatment in Fibromyalgia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237595
• Other study ID #: 492023
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Kasr El Aini Hospital
• Contact: Hadeel A Elegily, dr
• Phone: 00201066496611
• Email: hadilalielegily[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Vagus nerve stimulation
Electrical stimulation of the vagus nerve.

Drug:
• Medical treatment
Medical treatment for fibromyalgia patients

Combination Product:
• Combined vagus nerve stimulation and medical treatment
Combination of the two interventions

Locations

Country	Name	City	State
Egypt	Kasr Elainy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale 0-10	A 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme "worst pain imaginable". decrease i scale means improvement	2 months
Primary	Symptom severity scale score	A 0-12 score denoting the severity of symptoms. decrease in the score means improvement.	2 months
Primary	Widespread pain index	A 0 - 19 score denoting the number of areas the patient has had pain over the last week. decrease in value means improvement.	2 months
Primary	Fibromyalgia severity scale	Is the sum of both widespread pain index, and symptom severity scale score. A decrease in value means improvement	2 months
Secondary	Beck anxiety scale	a 21 -item self-report inventory for measuring the severity of anxiety. A decrease in value means improvement.	2 months
Secondary	Beck depression inventory	A 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations, decrease in the value means improvement	2 months
Secondary	Pittsburgh sleep quality index	A 19 items idex, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	2 months