Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia
Condition: Chronic Widespread Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Transcutaneous Vagal Nerve Stimulation (tVNS); Motivational nondirective resonance breathing (MNRB)
Intervention type(s): Device; Other
Intervention description(s): The tVNS system consists of a non-invasive, handheld stimulator and ear electrode that participants wear like an earphone. Intensity, pulse duration, and frequency of the tVNS stimulation is optimized in order to induce signals in thick-myelinated Aβ fibres of the auricular branch of the vagus nerve (ABVN).; Motivational nondirective resonance breathing (MNRB) is a type of diaphragmatic breathing technique that trains the body to breathe at resonance frequency with a mental state of open-awareness.
Other intervention name(s): Vagus Nerve Stimulation; Diaphragmatic Breathing
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study will use a randomized controlled experimental design. A total of N=112 consenting CWP patients will be consecutively recruited from the Department of Pain Management and Research at Oslo University Hospital, Norway, and randomized to one of four intervention groups. Participants will be randomized to either a version 1 tVNS group, a version 2 tVNS group, a version 1 MNRB group, or a version 2 MNRB group. Both version 1 and 2 treatment interventions will be delivered at home, twice a day, for 15 min in the morning and for 15 min in the evening, for a total duration of 2 weeks. The participants' adherence to both interventions will be monitored electronically. An 80 % completion of tVNS stimulation and MNRB training will be regarded as adequate adherence in this project. Participants are invited to the clinic twice for pre- and post-intervention data collection.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic widespread pain; heart rate variability; pain intensity; diaphragmatic breathing; vagus nerve stimulation; fibromyalgia