Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia
CompletedNot applicableNCT03180554
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Body Versus Machine: Motivational Nondirective Resonance Breathing Versus Transcutaneous Vagus Nerve Stimulation in the Treatment of Fibromyalgia
- Conditions
- Interventions
- Device: Transcutaneous Vagal Nerve Stimulation (tVNS)
- Other: Motivational nondirective resonance breathing (MNRB)
- Sponsor
- Charles Ethan Paccione, M.S., M.A.
- Organization
- Oslo University Hospital
- Start date
- 2019-03-15
- Primary completion
- 2020-10-09
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Confirmatory diagnosis of chronic widespread pain, including fibromyalgia * Widespread pain index (WPI) ≥ 7 and symptom severity scale (SSS) score ≥ 5 OR WPI of 4-6 and SSS score ≥ 9 * Generalized pain in at least 4 of 5 body regions must be present * Pain symptoms have been generally present for at least 3 months * Average pain intensity ≥ 6 on a 0-10 numerical rating scale, where 0 represents "no pain" and 10 represents the "worst pain imaginable" Exclusion Criteria: * History and/or presence of comorbid severe neurological or psychiatric disorders (e.g., mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) * Neurodegenerative disorders (e.g., Parkinson´s, Alzheimer´s, Huntington´s disease) * Pregnancy or planned pregnancy * Planned surgery * Eating disorder (e.g., obesity, anorexia nervosa, etc.) * Head trauma * Migraine * Active heart implants (e.g., pacemaker) * Active ear implants (e.g., cochlear implant) * Individuals who have practiced meditation consistently (for more than 20 min/day) within the last 6 months
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03180554