Investigation of the Effects of Transcutaneous Vagus Nerve Stimulation on Fibromyalgia. A Double Blind, Sham-controlled Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Stimulation of the vagus nerve, a parasympathetic nerve that controls the digestive, the vascular and immune systems, produces pain relief in various clinical conditions. Transmission via vagal afferents to the nucleus of the solitary tract has been proposed as the primary physiological mechanism that reduces pain intensity following vagal stimulation. Medication is one of the pillars of dealing with chronic pain, with several benefits, but also side effects. Fibromyalgia is an idiopathic chronic pain syndrome with few, effective and safe treatments. However, current research in the field of vagal innervation suggests psychophysiological and electrical ways by which the syndrome may be treated.The chronic pain symptoms of fibromyalgia patients may benefit from vagus nerve stimulation, by normalizing the autonomic and immune system dysfunction that causes their respective symptoms. However, the effects of multiple sessions of transcutaneous vagus nerve stimulation (tVNS) in fibromyalgia have not been evaluated in randomized clinical trials. The hypothesis of our study is to evaluate if the addition of transcutaneous stimulation of the auricular branch of the vagus nerves in patients with fibromyalgia, can lead to better pain control and quality of life. We will offer a 2-week treatment (14 sessions of 30 minutes) in a randomized double-blind controlled trial. The sample of the study, which will be conducted in the pain clinic of the Aretaieion University General Hospital, will be consisted of 120 patients, who will be divided into 2 groups (1st group: standard pharmacological treatment + active tVNS, 2nd group: standard pharmacological treatment + sham tVNS). The study is designed to determine, if standard pharmacological treatment combined with 14 sessions of tVNS is able to improve pain symptomatology in fibromyalgia and all symptoms of this syndrome, by using appropriate scales. This study examines a new and potentially impactful way to address a major public health issue where prevalence is high in given groups, its impact is multidimensional and treatment options are limited. The holistic treatment of chronic pain, including its neurobiological, cognitive, behavioral and psychological components, may become a valuable aid in the completion of the research project, with the ultimate aim of the study being the establishment of non-invasive stimulation of the vagus nerve for the treatment of chronic pain in clinical practice in the future.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Women between 18-79 years old

• Women diagnosed with Fibromyalgia according to the ACR 2016 Revised Classification Criteria

• Moderate to high pain intensity according to analog pain scales (above 4 points over 10), for more than 6 months

• Cognitive function sufficient to understand the experiments and follow instructions

• Ability to read and understand all information on the device display.

• Ability to adjust the strength of the stimulation or give feedback regarding their response to the device (feeling tingling/pulsating/pain).

• Ability to comply with the recommended therapy regiment of 30 min per day.

• The ear electrode needs to fit the patient.

• Patients with physical or mental disabilities

• The patient must be able to use the device by themselves or

• The patients' caretaker can operate the device on the patient. In this case the patient --must still be able to give feedback regarding their response to the device

Locations
Other Locations
Greece
Aretaieion University Hospital
RECRUITING
Athens
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 120
Treatments
Active_comparator: active tVNS group
1st group Standard pharmacological Treatment according to EULAR + active tVNS, 30min/session, 7 days/week for 2 weeks (14 sessions total) Regarding the standard pharmacological treatment we will follow a stepwise approach according to the EULAR (European League Against Rheumatism) recommendations. The patients will be randomized by using randomization.org
Sham_comparator: sham tVNS group
2nd group Standard pharmacological Treatment according to EULAR + sham tVNS, 30min/session, 7 days/week for 2 weeks (14 sessions total) Regarding the standard pharmacological treatment we will follow a stepwise approach according to the EULAR (European League Against Rheumatism) recommendations. The patients will be randomized by using randomization.org
Related Therapeutic Areas
Sponsors
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov