The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Clinical Pain
研究概览
简要总结
The purpose of this study is to examine the effects of a brief mindfulness meditation intervention on clinical and experimental pain in fibromyalgia (FM) patients as compared to a wait-list control condition. Based on prior research, investigators' working hypothesis is that this intervention will decrease the severity of FM-associated clinical pain and experimentally induced pain in comparison to pre-intervention scores and a wait-list control group. Additionally, based on prior work, investigators postulate that mindfulness meditation training will decrease a) depression, b) state anxiety, c) overall disease severity, and d) perceived stress, while increasing e) quality of sleep, and f) mindfulness skills in comparison to pre-intervention scores and the wait-list control group.
Investigators will also be testing if decreases in pain ratings during meditation correspond to increases in parasympathetic activity. The relative systemic contributions of the parasympathetic and sympathetic branches of the Autonomic Nervous System (ANS) can be examined by measuring heart rate variability (HRV), or the variability in the beat-to-beat interval. Fast acting, parasympathetically-mediated high frequency (HF) changes in heart rate variability (HF HRV; 0.15-0.40 Hz) provide a reliable indicator of parasympathetic activity. Importantly, decreased HF HRV correlates with increased pain. Investigators therefore will employ psychophysical and physiological methodologies to test the hypothesis that the analgesic effects of mindfulness meditation in FM patients are associated with increases in HF HRV.
详细描述
Mindfulness and FM-Related Clinical Pain
The lack of clinical improvement in FM patients in response to pharmacologic therapy provides support for the development and validation of cost-effective, narcotic free, cognitive approaches to treating FM.
If the benefits of mindfulness-based interventions can be realized after brief mental training, then this technique could better facilitate treatment in pain patients and become more attractive to clinicians and health insurers. To this extent, investigators have previously shown that four days (20m/d) of mindfulness meditation training in healthy subjects significantly reduced experimental pain unpleasantness by 57% and pain intensity by 40% when compared to rest. Additionally, investigators found that four days of mindfulness-based mental training significantly reduced state anxiety, and these results were realized even after one meditation session. However, it remains unclear if brief mindfulness-based mental training can reliably reduce clinical pain in FM patients. To this extent, investigators will test the efficacy of a brief, mindfulness meditation intervention on FM-related pain. Providing a short, but potentially effective intervention could offset the physical, temporal, and financial barriers to treatment in FM patients.
Mindfulness and FM-Related Experimental Pain
FM patients have been found to have lower pain thresholds across multiple noxious stimulation modalities and suffer from hyperalgesia, an increased sensitivity to pain. While pain thresholds correspond to the point at which a stimulus is experienced as painful, sensitivity to pain refers to an individual's subjective experience of a noxious stimulus. Unfortunately, no known studies have examined the effects of mindfulness meditation on FM-related heat pain thresholds and heat pain sensitivity. The employment of experimentally induced pain manipulations could provide the means to disentangle the constellation of interactions that affect the subjective experience of FM-related pain. To this extent, in addition to examining the effects of mindfulness meditation on clinical pain, investigators will also employ psychophysical methodologies to determine if mindfulness meditation attenuates experimentally induced pain in FM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Sixty individuals (18-65 years old; male and female) of all ethnic backgrounds will be examined.
- •Participants should meet the 2010 revised American College of Rheumatology (ACR) criteria for FM.
- •Additionally, only patients who have been on the same medication regimen for FM for the past four weeks will be included.
- •Patients must also report a score of greater than or equal to 50 on the Revised FM Impact Questionnaire (FIQR) and a score of less than 20 on the Patient Health Questionnaire-8 (PHQ-8) to be included in the study.
- •Importantly, Dr. Dennis Ang will confirm FM diagnoses.
排除标准
- •Individuals with chronic heart or lung conditions, who are pregnant, smoke, are currently waiting for a response to an application for disability, have been diagnosed with schizophrenia, bipolar, or any other mental illness or personality disorder, or are planning on undergoing any major elective surgery in the next three months will be excluded.
- •Additionally, those patients who have ever meditated (excluding yoga) will be excluded.
研究组 & 干预措施
Behavioral: Mindfulness Meditation
Training will be held in groups of up to five participants. All of the participants within this group will receive up to 6 days (20m/d) of meditation training to be administered over 15 days. This is a paradigm similar to one employed in previous studies.
干预措施: Mindfulness Meditation Training (Behavioral)
结局指标
主要结局
Clinical Pain
时间窗: 17 days
Investigators will use "pre-intervention" vs. "post-intervention" VAS overall pain ratings for the previous two weeks (those obtained from sessions 1 and 8, respectively) to test the hypothesis that a mindfulness meditation intervention will decrease clinical pain in FM patients. Investigators will employ a 2 (meditation vs. control) X 2 ("pre" vs. "post-intervention") repeated measures ANOVA (RM ANOVA) to test hypothesized differences between groups. Follow-up post-hocs will be conducted to test significant main effects and interactions.
次要结局
- Experimental Pain(17 days)
- Fibromyalgia-associated symptoms(17 days)
- Fibromyalgia-associated anxiety(17 days)
- High Frequency Heart Rate Variability (HF HRV)(17 days)