NCT06237595

Vagus Nerve Stimulation in Fibromyalgia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-30
• Primary completion: 2024-10-30
• Completion: 2025-02-28
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: Egypt