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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2020-10-09

Brief Summary

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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.

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Detailed Description

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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

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Chronic Widespread Pain Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

All statistical analyses will be performed by a statistician who is blinded by participants' ID and health record.

Study Groups

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tVNS version 1

Transcutaneous vagus nerve stimulation (tVNS) version 1 will be delivered non-invasively via a portable take-home stimulation device which attaches to the concha of the outer ear. Intensity, pulse duration, and frequency is optimised by the participant. Participants will receive a 15-minute stimulation twice a day (once in the morning upon waking and once in the evening before bed) for 2 weeks.

Group Type OTHER

Transcutaneous Vagal Nerve Stimulation (tVNS)

Intervention Type DEVICE

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).

tVNS version 2

Transcutaneous vagus nerve stimulation (tVNS) version 2 will be delivered non-invasively via a portable take-home stimulation device which attaches to the center of the left ear lobe. Intensity, pulse duration, and frequency is optimised by the participant. Participants will receive a 15-minute stimulation twice a day (once in the morning upon waking and once in the evening before bed) for 2 weeks.

Group Type OTHER

Transcutaneous Vagal Nerve Stimulation (tVNS)

Intervention Type DEVICE

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).

MNRB version 1

Motivational nondirective resonance breathing (MNRB) version 1 will be delivered via a take-home guided breathing apparatus. Participants will be guided through a deep breathing session. Participants will practice MNRB version 1 for 15-minutes twice a day (once in the morning upon waking and once in the evening before bed) for 2 weeks.

Group Type OTHER

Motivational nondirective resonance breathing (MNRB)

Intervention Type OTHER

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.

MNRB version 2

Motivational nondirective resonance breathing (MNRB) version 2 will be delivered via a take-home guided breathing apparatus. Participants will be guided through a paced breathing session. Participants will practice MNRB version 2 for 15-minutes twice a day (once in the morning upon waking and once in the evening before bed) for 2 weeks.

Group Type OTHER

Motivational nondirective resonance breathing (MNRB)

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Vagus Nerve Stimulation Diaphragmatic Breathing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No