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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug, Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
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• Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study.

Locations
Other Locations
Egypt
Kasr Elainy Hospital
RECRUITING
Cairo
Contact Information
Primary
Hadeel A Elegily, dr
hadilalielegily@gmail.com
00201066496611
Time Frame
Start Date: 2023-09-30
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 90
Treatments
Active_comparator: 1 Vagus nerve stimulation
The first group will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a 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, over the carotid pulse just medial to the sternocleidomastoid muscle (Molero-Chamizo et al., 2022) 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 (Kutlu et al., 2020). 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
Active_comparator: 2 Medical treatment
This group 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.
Active_comparator: 3 Combined vagus nerve stimulation and medical treatment
This group will receive cervical t-VNS in the same protocol like the vagus nerve stimulation group, 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.
Related Therapeutic Areas
Sponsors
Leads: Kasr El Aini Hospital

This content was sourced from clinicaltrials.gov