Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia

Body Versus Machine: Motivational Nondirective Resonance Breathing Versus Transcutaneous Vagus Nerve Stimulation in the Treatment of Fibromyalgia

This randomized controlled trial aims to compare the efficacy of two vagal nerve innervation treatments, motivational nondirective resonance breathing and transcutaneous vagus nerve stimulation, on heart rate variability and pain intensity in patients suffering from CWP. This project tests new and potentially effective means of treating a major global and public health concern where prevalence is high, disability is severe, and treatment options are limited.

The primary objective of this randomized controlled trial is to investigate the effects of motivational nondirective resonance breathing (MNRB) and transcutaneous vagus nerve stimulation (tVNS) on autonomic health and pain intensity in participants diagnosed with chronic widespread pain (CWP). Two versions of MNRB and two versions of tVNS will be delivered and practiced by participants at home for two weeks. The primary outcome is photoplethysmography (PPG) measured heart rate variability (HRV). Secondary outcomes are self report numeric rating scale (NRS) pain intensity, FM pain severity and associated parameters, computerized cuff pressure algometry, blood pressure, psychological distress and health related quality of life.

Inclusion Criteria:

• Confirmatory diagnosis of chronic widespread pain, including fibromyalgia
• Widespread pain index (WPI) ≥ 7 and symptom severity scale (SSS) score ≥ 5 OR WPI of 4-6 and SSS score ≥ 9
• Generalized pain in at least 4 of 5 body regions must be present
• Pain symptoms have been generally present for at least 3 months
• Average pain intensity ≥ 6 on a 0-10 numerical rating scale, where 0 represents "no pain" and 10 represents the "worst pain imaginable"

Exclusion Criteria:

• History and/or presence of comorbid severe neurological or psychiatric disorders (e.g., mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders)
• Neurodegenerative disorders (e.g., Parkinson´s, Alzheimer´s, Huntington´s disease)
• Pregnancy or planned pregnancy
• Planned surgery
• Eating disorder (e.g., obesity, anorexia nervosa, etc.)
• Head trauma
• Migraine
• Active heart implants (e.g., pacemaker)
• Active ear implants (e.g., cochlear implant)
• Individuals who have practiced meditation consistently (for more than 20 min/day) within the last 6 months