Vagus Nerve Stimulation in Fibromyalgia

January 24, 2024 updated by: Hadeel Ali Ramadan Moustafa Elegily, Kasr El Aini Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Recruiting
        • Kasr Elainy Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Vagus nerve stimulation
Electrical stimulation of the vagus nerve.
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.
Drug: Medical treatment
Medical treatment for fibromyalgia patients
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.
Combination product: Combined vagus nerve stimulation and medical treatment
Combination of the two interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale 0-10
Time Frame: 2 months
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
Symptom severity scale score
Time Frame: 2 months
A 0-12 score denoting the severity of symptoms. decrease in the score means improvement.
2 months
Widespread pain index
Time Frame: 2 months
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
Fibromyalgia severity scale
Time Frame: 2 months
Is the sum of both widespread pain index, and symptom severity scale score. A decrease in value means improvement
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck anxiety scale
Time Frame: 2 months
a 21 -item self-report inventory for measuring the severity of anxiety. A decrease in value means improvement.
2 months
Beck depression inventory
Time Frame: 2 months
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
Pittsburgh sleep quality index
Time Frame: 2 months
A 19 items idex, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Hadeel A Elegily, DR, Kasr Elainy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 492023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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