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Table 1 World Health Organization Trial Registration Data

From: Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

Data category

Information

Primary registry and trial identifying number

ClinicalTrials.gov

NCT03180554

Date of registry in primary registry

08/06/2017

Secondary identifying numbers

Southeast Regional Health Authority, Norway, Project Number: 2017/766

Cristin Project ID: 619480

Source of monetary and material support

Southeast Regional Health Authority, Norway

Primary sponsor

Southeast Regional Health Authority, Norway

Contact for public queries

Charles Ethan Paccione, M.S., M.A., Ph.D. Fellow

Email: charlespaccione@gmail.com

Contact for scientific queries

Charles Ethan Paccione, M.S., M.A., Ph.D. Fellow

Email: charlespaccione@gmail.com

Department of Pain Management and Research

Oslo University Hospital, Ullevål

Public title

Body versus Machine: Meditative Breathing versus Vagus Nerve Stimulation in the Treatment of Chronic Widespread Pain

Scientific title

Body versus Machine: Motivational Nondirective Resonance Breathing versus Transcutaneous Vagus Nerve Stimulation in the Treatment of Fibromyalgia

Country of recruitment

Norway

Health condition studied

Chronic widespread pain, fibromyalgia

Interventions

Motivational nondirective resonance breathing (active and Sham)

Transcutaneous vagus nerve stimulation (active and sham)

Key inclusion and exclusion 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); 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

Study type

Randomized controlled clinical trial

Interventional

Allocation: randomized

Intervention model: parallel assignment

Masking: double blind (subject, caregiver, investigator, outcomes assessor)

Primary purpose: treatment

Date of first enrolment

June 6, 2019

Target sample size

112

Recruitment status

Recruiting

Primary outcome

Heart rate variability (HRV)

Key secondary outcome

Numerical rating scale for average pain intensity; pain detection threshold; pain tolerance threshold; pressure pain limit; blood pressure; credibility/expectancy; health-related quality of life; stress and depression; interoceptive awareness; spirituality; catastrophizing; interference