NCT03180554

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Charles Ethan Paccione, M.S., M.A. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Widespread Pain
• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	Transcutaneous Vagal Nerve Stimulation (tVNS)	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).
OTHER	Motivational nondirective resonance breathing (MNRB)	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.

Timeline

• Start date: 2019-03-15
• Primary completion: 2020-10-09
• Completion: 2020-10-09
• First posted: 2017-06-08
• Last updated: 2022-01-04

Locations

1 site across 1 country: Norway