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The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581332
Recruitment Status : Withdrawn (Due to insufficient interest in the study and enrollment has been closed)
First Posted : October 20, 2015
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Mindfulness Meditation Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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.
Behavioral: Mindfulness Meditation Training
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.




Primary Outcome Measures :
  1. Clinical Pain [ Time Frame: 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.


Secondary Outcome Measures :
  1. Experimental Pain [ Time Frame: 17 days ]

    Heat Pain Sensitivity Testing: Investigators will examine data corresponding to the pre and post intervention sessions separately. Investigators will employ a univariate ANOVA to assess if there are baseline differences in pain between groups. With respect to the post-intervention session, investigators will employ a 2 (group) X 2 (rest vs. control/meditation) RM ANOVA to test the hypothesis that meditation will reduce pain ratings when compared to rest and the control group. Follow-up post-hoc tests will be conducted to examine significant main effects and interactions.

    Heat Pain Threshold Testing: In order to test the hypothesis that heat pain thresholds will increase after meditation training and when compared to the wait-list control group, investigators will conduct a 2 (group) X 2 ("pre" vs. "post-intervention") RM ANOVA. Follow-up post-hocs will be conducted to test significant main effects and interactions.


  2. Fibromyalgia-associated symptoms [ Time Frame: 17 days ]
    Investigators will use "pre" vs. "post" ratings (those obtained at sessions 1 and 8, respectively) on the BPI, PHQ-8, CES-D, FIQR, PSS, PCS, PSQI, MASQ, and FMI to test the hypothesis that mindfulness meditation decreases a) pain-related measures, b) depression, c) disease severity d) perceived stress, and e) pain catastrophizing while increasing f) quality of sleep, g) cognitive function, and h) mindfulness ratings. Investigators will use a 2 (group) X 2 ("pre" vs. "post-intervention") RM ANOVA for each of these scales to test the hypotheses. Follow-up post-hocs will be conducted to test significant main effects and interactions.

  3. Fibromyalgia-associated anxiety [ Time Frame: 17 days ]
    In order to test the hypothesis that mindfulness meditation will reduce SAI scores, investigators will perform a 7 (experimental sessions employing meditation) X 2 ("pre" vs. "post") RM ANOVA where "pre" corresponds to SAI scores prior to each intervention and "post" corresponds to SAI scores after each intervention. Follow-up post-hocs will be conducted to test significant main effects and interactions.

  4. High Frequency Heart Rate Variability (HF HRV) [ Time Frame: 17 days ]
    Separate multiple regression models (one for pain intensity and one for pain unpleasantness ratings) will be conducted to test the hypothesis that the analgesic effects of mindfulness meditation will be associated with increases in HF HRV. The regression model(s) will examine if group (wait-list control; meditation) is uniquely associated with the overall model examining the proposed relationship between pain ratings and HF HRV, respectively. Investigators will conduct similar regression models for heat pain thresholds, where the temperature at which a patient first feels pain during session 8 is entered as the dependent variable in the regression model. Investigators will also conduct a similar regression model for clinical pain, where session 8 VAS ratings (intensity and unpleasantness) relating to pain over the previous 2 weeks are entered as the dependent variable, respectively.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581332


Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Fadel Zeidan, PhD Wake Forest University Health Sciences
Principal Investigator: Dennis Ang, MD Wake Forest University Health Sciences
Publications:
Cohen BH, Lea RB (2004) Essentials of statistics for the social and behavioral sciences. Hoboken, N.J.: Wiley.
Cohen S, Williamson, G. (1988) Perceived stress in a probability sample of the United States. Newbury Park, CA: Sage.
Hays B (2008) A practical security analysis. In: SANS Institute.
Institute of Medicine (US) Committee on Advancing Pain Research C, and Education (2011) Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington D.C: National Academies Press.
Kabat-Zinn J (1990) Full Catastrophe Living. New York: Delta Trade Paperbacks.
Pizzo PAC, N.M. (2011) Relieving pain in America: A blueprint for transforming prevention, care, education, and research. In: Institute of Medicine.
Radloff LS (1977) The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 1.
Spielberger CD, Goruch, R.L., Lushene, R., Vagg, P.R. Jacobs, G.A. (1983) Manual for the state-trati anxiety inventory. Palo Alt, CA: Consulting Psychologists Press.
Sullivan MJL, Bishop SR, Pivik J (1995) The Pain Catastrophizing Scale: Development and validation. Psychol Assessment 7:524-532.
Walach H, Buchheld N, Buttenmuller V, Kleinknecht N, Schmidt S (2006) Measuring mindfulness - the Freiburg Mindfulness Inventory (FMI). Pers Indiv Differ 40:1543-1555.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02581332    
Other Study ID Numbers: 32852
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wake Forest University Health Sciences:
behavioral intervention
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases