Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia
Body Versus Machine: Deep Breathing Versus Vagus Stimulation for 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. Primary outcomes are
 photoplethysmography (PPG) measured heart rate variability (HRV) and self report numeric
 rating scale (NRS) pain intensity. Secondary outcomes are pain detection threshold (PDT) and
 pain tolerance threshold (PTT) determined by pressure cuff algometry, blood pressure, as well
 as 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