The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

Fibromyalgia Clinical Trial

Official title: The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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.

Heart Rate Variability (HRV) and Fibromyalgia

The Autonomic Nervous System (ANS) is critical for control of homeostatic measures such as blood pressure, body temperature, and heart rate. HRV, or the variability in the beat-to-beat interval, can be used to assess the systemic relative contributions of the parasympathetic and sympathetic branches of the ANS. Parasympathetic effects on heart rate are mediated through the vagus nerve relatively quickly, thus classifying high frequency changes in heart rate (HF HRV; 0.15-0.40 Hz) as a marker of parasympathetic activity.

Interestingly, decreased HF HRV can provide a robust physiological correlate of the subjective experience of pain. In fact, decreased HF HRV is directly associated with a number of clinical pain conditions including fibromyalgia. Additionally, recent findings have shown that meditation directly increases HF HRV. 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.

Specific Aims

To examine the effects of a brief mindfulness meditation intervention on clinical pain (the primary outcome) and experimental pain (the secondary outcome) in FM patients as compared to a wait-list control condition. Investigators will also examine if the analgesic effects of mindfulness meditation are correlated with increases in HF HRV.

Hypotheses

Investigators hypothesize that a brief mindfulness meditation intervention will decrease clinical and experimental pain in FM patients when compared to a wait-list control condition. Investigators hypothesize that the analgesic effects of meditation will be correlated with increases in HF HRV. Investigators also predict that meditation will decrease depression, state anxiety, overall disease severity, and perceived stress, while increasing quality of sleep, and mindfulness skills in comparison to pre-intervention scores and the wait-list control group.

Study Objectives

Primary Objective: The primary objective of this study is to determine if a brief mindfulness meditation intervention can improve FM-related clinical pain. Based on prior research, investigators' working hypothesis is that this intervention will decrease the severity of FM-associated pain in comparison to pre-intervention scores and a wait-list control group.

Secondary Objective: The secondary objective of this study is to determine if a brief mindfulness-based meditation intervention can impact a number of factors associated with FM while proving to be a feasible intervention for this patient population, as measured by an attrition rate of less than 25%. First, investigators will test the hypothesis that mindfulness meditation, in comparison to the wait-list control group and pre-intervention experimental pain ratings, will reduce the subjective experience of experimentally induced pain in FM patients. Specifically, based on preliminary studies, investigators hypothesize that a brief mindfulness meditation intervention will decrease heat pain sensitivity and increase heat pain thresholds in this patient population (see Interventions and Interactions). Additionally, investigators will test the hypothesis that the decreases in clinical and/or experimental pain caused by mindfulness meditation will be associated with increases in HF HRV. Finally, investigators will test if a brief mindfulness-based meditation intervention can improve psychological disposition in FM patients. 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. ;

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT02581332
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Completion date: January 2017