Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

Charles Ethan Paccione, Lien My Diep, Audun Stubhaug, Henrik Børsting Jacobsen, Charles Ethan Paccione, Lien My Diep, Audun Stubhaug, Henrik Børsting Jacobsen

Abstract

Background: Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM.

Methods: The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life.

Discussion: The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited.

Trial registration: ClinicalTrials.gov NCT03180554 . Registered on August 06, 2017.

Keywords: Chronic widespread pain; Fibromyalgia; Heart rate variability; Motivational nondirective resonance breathing; Pain intensity; Vagus nerve stimulation.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overview of study design
Fig. 2
Fig. 2
tVNS device. Nemos® transcutaneous vagus nerve stimulation (tVNS) device (Figure taken from [69])
Fig. 3
Fig. 3
Signal processing pipeline for CameraHRV (Table taken from [80])
Fig. 4
Fig. 4
BarTek design
Fig. 5
Fig. 5
Signal processing pipeline for BarTek device. Real-time signal processing is based on a zero-crossing algorithm with further modifications. It is important to note that zero-crossing detection is based on a dynamically adjusted threshold. The basic signal processing algorithm consists of seven steps
Fig. 6
Fig. 6
Clinical visitations. a Clinical visitation 1 (CVI). b Clinical visitation II (CVII)
Fig. 7
Fig. 7
Data collection timeline. a Heart rate variability. b Blood pressure. c Computerized cuff-pressure algometry
Fig. 8
Fig. 8
Daily home intervention procedure

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