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

NCT03180554 | Completed

• 2 other identifiers: 2017/88922017046
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic widespread pain; heart rate variability; pain intensity; diaphragmatic breathing; vagus nerve stimulation; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Heart Rate Variability (HRV)

  The root mean square of successive differences (RMSSD) will be derived from photoplethysmography (PPG) recordings and serve as the primary HRV outcome of interest. RMSSD corresponds to the parasympathetic regulation of heart beats (i.e. vagal activity) which is associated with self-report average pain intensity in CWP patients. Three readings on the right index finger are taken in a sitting position, separated by a one minute intervals, and after a five minute acclimatization (resting) period. The average of the last two measurements will be used in the final analyses.

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

Secondary Outcomes (10)

• Change from Baseline Numeric Rating Scale (NRS) for Average Pain Intensity

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

• Change from Baseline Fibromyalgia severity (FS)

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

• Change from Baseline Pain Detection Threshold (PDT), Pain Tolerance Threshold (PTT), and Pressure-Pain Limit (PPL)

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

• The Hopkins Symptom Checklist-25 (HSCL-25)

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

• Change from Baseline Blood Pressure (BP)

  Baseline (Pre-2 week Intervention); Post-2 week Intervention

Study Arms (4)

tVNS version 1

OTHER

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.

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

tVNS version 2

OTHER

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.

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

MNRB version 1

OTHER

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.

Other: Motivational nondirective resonance breathing (MNRB)

MNRB version 2

OTHER

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.

Other: Motivational nondirective resonance breathing (MNRB)

Interventions

Transcutaneous Vagal Nerve Stimulation (tVNS) 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).

Also known as: Vagus Nerve Stimulation

tVNS version 1; tVNS version 2

Motivational nondirective resonance breathing (MNRB) 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.

Also known as: Diaphragmatic Breathing

MNRB version 1; MNRB version 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital, Department of Pain Management and Research

Oslo, 0450, Norway

Location

Related Publications (2)

• Paccione CE, Stubhaug A, Diep LM, Rosseland LA, Jacobsen HB. Meditative-based diaphragmatic breathing vs. vagus nerve stimulation in the treatment of fibromyalgia-A randomized controlled trial: Body vs. machine. Front Neurol. 2022 Nov 3;13:1030927. doi: 10.3389/fneur.2022.1030927. eCollection 2022.

  PMID: 36438970 DERIVED

• Paccione CE, Diep LM, Stubhaug A, Jacobsen HB. Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial. Trials. 2020 Sep 23;21(1):808. doi: 10.1186/s13063-020-04703-6.

  PMID: 32967704 DERIVED

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Pain

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Audun Stubhaug, M.D., D.Med.Sci.

  Oslo University Hospital

  STUDY DIRECTOR

• Leiv Arne Rosseland, M.D.,Ph.D.

  Oslo University Hospital

  STUDY CHAIR

• Henrik B Jacobsen, Ph.D.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Charles E Paccione, M.S., M.A.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All statistical analyses will be performed by a statistician who is blinded by participants' ID and health record.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. Fellow in Medicine and Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: March 15, 2019
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

NO (1)