Clinical trial NCT03180554: Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia
Official title: Body Versus Machine: Motivational Nondirective Resonance Breathing Versus Transcutaneous Vagus Nerve Stimulation in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Widespread Pain
Fibromyalgia
Keywords: chronic widespread pain
heart rate variability
pain intensity
diaphragmatic breathing
vagus nerve stimulation
fibromyalgia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Heart Rate Variability (HRV)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
Secondary outcomes:
measure: Change from Baseline Numeric Rating Scale (NRS) for Average Pain Intensity
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Change from Baseline Fibromyalgia severity (FS)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Change from Baseline Pain Detection Threshold (PDT), Pain Tolerance Threshold (PTT), and Pressure-Pain Limit (PPL)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: The Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Change from Baseline Blood Pressure (BP)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: EQ-5D-5L
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Spirituality and Coping (SpREUK-15)
timeFrame: Baseline (Pre-2 week Intervention); Post-2 week Intervention
measure: Patient Global Impression of Change (PGIC)
timeFrame: Post-2 week Intervention
measure: Credibility / Expectancy Questionnaire (CEQ)
timeFrame: Baseline (Pre-2 week Intervention)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Pain Management and Research
Study officials:
affiliation: Oslo University Hospital
name: Audun Stubhaug, M.D., D.Med.Sci.
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Leiv Arne Rosseland, M.D.,Ph.D.
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Henrik B Jacobsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Charles E Paccione, M.S., M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.