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Trial record 20 of 96 for:    fibromyalgia | Open Studies | Interventional Studies

The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Dennis C. Ang, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT02581332
First received: October 14, 2015
Last updated: October 19, 2015
Last verified: October 2015
  Purpose

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 Intervention
Fibromyalgia
Behavioral: Mindfulness Meditation Training
Other: Wait-list Control/Usual Care Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Clinical Pain [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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:
  • Experimental Pain [ Time Frame: 17 days ] [ Designated as safety issue: No ]

    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.


  • Fibromyalgia-associated symptoms [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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.

  • Fibromyalgia-associated anxiety [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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.

  • High Frequency Heart Rate Variability (HF HRV) [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: October 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Meditation Training 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.
Wait-list Control/Usual Care Group Other: Wait-list Control/Usual Care Group
If assigned to the wait-list control group, participants may complete sessions 1 and 8 of the study. No behavioral intervention will be performed, and subjects will continue their usual treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02581332

Contacts
Contact: Adrienne Adler, MPH 336-716-9302 aadler@wakehealth.edu
Contact: Dennis Ang, MD 336-713-4264 dang@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Dennis Ang, MD         
Principal Investigator: Fadel Zeidan, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Fadel Zeidan, PhD Wake Forest Baptist Health
Principal Investigator: Dennis Ang, MD Wake Forest Baptist Health
  More Information

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.
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.

Responsible Party: Dennis C. Ang, Section Chief, Rheumatology and Immunology; Associate Professor, Rheumatology and Immunology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT02581332     History of Changes
Other Study ID Numbers: 32852 
Study First Received: October 14, 2015
Last Updated: October 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
behavioral intervention

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 08, 2016