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FibromyalgiaNCT02581332

The Effects of Mindfulness Meditation on Fibromyalgia-Related Pain

A study testing Mindfulness Meditation Training in people with Fibromyalgia, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia
What is being tested?
Mindfulness Meditation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2017to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions
Fibromyalgia
Being tested
Mindfulness Meditation Training
Keywords
behavioral intervention
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Meditation TrainingBehavioural

    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.

Study groups in NCT02581332
Study groupRoleWhat they receive
Behavioral: Mindfulness MeditationOtherTraining 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.
Receives: Behavioral: Mindfulness Meditation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 17 days

Secondary outcomes (4)
  1. Experimental Pain

    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.

    Measured: 17 days

  2. Fibromyalgia-associated symptoms

    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.

    Measured: 17 days

  3. Fibromyalgia-associated anxiety

    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.

    Measured: 17 days

  4. High Frequency Heart Rate Variability (HF HRV)

    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.

    Measured: 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: Due to insufficient interest in the study and enrollment has been closed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02581332
Sponsor's protocol ID
32852
Status last verified
Jan 2017
First submitted
14 Oct 2015
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Abeles AM, Pillinger MH, Solitar BM, Abeles M. Narrative review: the pathophysiology of fibromyalgia. Ann Intern Med. 2007 May 15;146(10):726-34. doi: 10.7326/0003-4819-146-10-200705150-00006.

    PubMed 17502633
  • Ang DC, Kaleth AS, Bigatti S, Mazzuca SA, Jensen MP, Hilligoss J, Slaven J, Saha C. Research to encourage exercise for fibromyalgia (REEF): use of motivational interviewing, outcomes from a randomized-controlled trial. Clin J Pain. 2013 Apr;29(4):296-304. doi: 10.1097/AJP.0b013e318254ac76.

    PubMed 23042474
  • Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, Goldstein DJ. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum. 2004 Sep;50(9):2974-84. doi: 10.1002/art.20485.

    PubMed 15457467
  • Arroyo JF, Cohen ML. Abnormal responses to electrocutaneous stimulation in fibromyalgia. J Rheumatol. 1993 Nov;20(11):1925-31.

    PubMed 7848390
  • Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res. 2002 Sep;53(3):737-40. doi: 10.1016/s0022-3999(02)00330-6.

    PubMed 12217446
  • Bair MJ, Matthias MS, Nyland KA, Huffman MA, Stubbs DL, Kroenke K, Damush TM. Barriers and facilitators to chronic pain self-management: a qualitative study of primary care patients with comorbid musculoskeletal pain and depression. Pain Med. 2009 Oct;10(7):1280-90. doi: 10.1111/j.1526-4637.2009.00707.x.

    PubMed 19818038
  • Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

    PubMed 19369473
  • Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness meditation and improvement in sleep quality and daytime impairment among older adults with sleep disturbances: a randomized clinical trial. JAMA Intern Med. 2015 Apr;175(4):494-501. doi: 10.1001/jamainternmed.2014.8081.

    PubMed 25686304
  • Buhrman M, Skoglund A, Husell J, Bergstrom K, Gordh T, Hursti T, Bendelin N, Furmark T, Andersson G. Guided internet-delivered acceptance and commitment therapy for chronic pain patients: a randomized controlled trial. Behav Res Ther. 2013 Jun;51(6):307-15. doi: 10.1016/j.brat.2013.02.010. Epub 2013 Mar 14.

    PubMed 23548250
  • Chaves JF, Brown JM. Spontaneous cognitive strategies for the control of clinical pain and stress. J Behav Med. 1987 Jun;10(3):263-76. doi: 10.1007/BF00846540.

    PubMed 3612783
  • Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

    PubMed 24737367
  • Coghill RC, Eisenach J. Individual differences in pain sensitivity: implications for treatment decisions. Anesthesiology. 2003 Jun;98(6):1312-4. doi: 10.1097/00000542-200306000-00003. No abstract available.

    PubMed 12766637
  • Coghill RC, McHaffie JG, Yen YF. Neural correlates of interindividual differences in the subjective experience of pain. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8538-42. doi: 10.1073/pnas.1430684100. Epub 2003 Jun 24.

    PubMed 12824463
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation Training in people with Fibromyalgia, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Pain (time frame: 17 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02581332, which also lists 67 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

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