The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.