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Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia

NCT03180554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-01-04

No results posted yet for this study

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.

Conditions

  • Chronic Widespread Pain
  • Fibromyalgia

Interventions

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.

Sponsors & Collaborators

  • Charles Ethan Paccione, M.S., M.A.

    lead OTHER

Principal Investigators

  • Audun Stubhaug, M.D., D.Med.Sci. · Oslo University Hospital

  • Leiv Arne Rosseland, M.D.,Ph.D. · Oslo University Hospital

  • Henrik B Jacobsen, Ph.D. · Oslo University Hospital

  • Charles E Paccione, M.S., M.A. · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2020-10-09
Completion
2020-10-09

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180554 on ClinicalTrials.gov