Body versus Machine: Motivational Nondirective Resonance Breathing versus Transcutaneous Vagus Nerve Stimulation for the Treatment of Chronic Widespread Pain

Chronic widespread pain (CWP), including Fibromyalgia, affects one in ten individuals within the general population and has the highest prevalence in Norway. CWP is a leading cause of long-term sick leave and emotional as well as physical distress. Many CWP treatments today are invasive, ineffective, and cause several adverse side effects. "Body versus Machine" is a study which investigates how two noninvasive, safe, portable, and potentially effective treatments for CWP increases wellbeing and decreases pain either through meditative-based deep breathing or noninvaisve electrical stimulation. These two treatments are called Motivational Nondirective Resonance Breathing (MNRB) and Transcutaneous Vagus Nerve Stimulation (tVNS). Individuals who have CWP and/or Fibromylagia who are interested in participating in this study are invited to submit a diagnostic study form via Nettskjema to the study coordinators. If eligible, participants will then be officially referred to the Department of Pain Management and Research at Oslo University Hospital, Ullevål, for their first clinical visitation. At the first clinical visitation, participants will undergo various testing procedures which will investigate the current state of their pain along with stress and overall wellbeing. Participants will then take their portable MNRB or tVNS treatments home to use everyday, 15 min in the morning and 15 min in the evening, for 2 weeks. After 2 weeks, participants will come back to the clinic for their second clinical visitation to see how their pain, stress, and overall wellbeing has changed.

This study will use a randomized single-blind controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB) and transcutaneous vagus nerve stimulation (tVNS) on patients diagnosed with chronic widespread pain (including fibromyalgia). Consenting CWP patients (N=112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, Ullevål, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N=56) will be randomized to one of two experimental tVNS groups. The other half (N=56) will be randomized to one of two MNRB groups. The interventions will be self-administered twice per day, at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks. Participants are invited to the clinic twice for pre- and post-intervention data collection. The primary outcomes are changes in photoplethysmography measured heart rate variability and self-reported pain intensity measured by the pain numeric rating scale. Secondary outcomes include changes in pain detection threshold and pain tolerance threshold determined by pressure cuff algometry, long-term stress regulation through hair cortisol, blood pressure, and health related quality of life and behavior.