Body Versus Machine: Motivational Nondirective Resonance Breathing Versus Transcutaneous Vagus Nerve Stimulation in the Treatment of Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change from Baseline Heart Rate Variability (HRV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All statistical analyses will be performed by a statistician who is blinded by participants' ID and health record.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
排除标准
- •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
- •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
结局指标
主要结局
Change from Baseline Heart Rate Variability (HRV)
时间窗: Baseline (Pre-2 week Intervention); Post-2 week Intervention
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.
次要结局
- Patient Global Impression of Change (PGIC)(Post-2 week Intervention)
- Change from Baseline Fibromyalgia severity (FS)(Baseline (Pre-2 week Intervention); Post-2 week Intervention)
- Change from Baseline Numeric Rating Scale (NRS) for Average Pain Intensity(Baseline (Pre-2 week Intervention); Post-2 week Intervention)
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Baseline (Pre-2 week Intervention); Post-2 week Intervention)
- Spirituality and Coping (SpREUK-15)(Baseline (Pre-2 week Intervention); Post-2 week Intervention)
- EQ-5D-5L(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)
- Credibility / Expectancy Questionnaire (CEQ)(Baseline (Pre-2 week Intervention))
研究者
Charles Ethan Paccione, M.S., M.A.
Ph.D. Fellow in Medicine and Health Sciences
Oslo University Hospital