The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

NCT02581332 | Withdrawn DMC

• 1 other identifier: 32852
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Clinical Pain

  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.

  17 days

Secondary Outcomes (4)

• Experimental Pain

  17 days

• Fibromyalgia-associated symptoms

  17 days

• Fibromyalgia-associated anxiety

  17 days

• High Frequency Heart Rate Variability (HF HRV)

  17 days

Study Arms (1)

Behavioral: Mindfulness Meditation

OTHER

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.

Behavioral: Mindfulness Meditation Training

Interventions

Mindfulness Meditation Training BEHAVIORAL

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.

Behavioral: Mindfulness Meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

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MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Fadel Zeidan, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Dennis Ang, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 20, 2015
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)