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

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

Status: Completed

Conditions: Fibromyalgia; Chronic Widespread Pain

Treatments: Device: Transcutaneous Vagal Nerve Stimulation (tVNS); Other: Motivational nondirective resonance breathing (MNRB)

Study type: Interventional

Funder types: Other

Identifiers

NCT03180554

2017/8892

2017046 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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105 participants in 4 patient groups

tVNS version 1

Other group

Description:

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.

Treatment:

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

tVNS version 2

Other group

Description:

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.

Treatment:

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

MNRB version 1

Other group

Description:

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.

Treatment:

Other: Motivational nondirective resonance breathing (MNRB)

MNRB version 2

Other group

Description:

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.

Treatment:

Other: Motivational nondirective resonance breathing (MNRB)