Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Migraine Clinical Trial

Official title:

Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695498
• Other study ID #: IRB00027845-B
• Secondary ID: K23AT008406
• Status: Completed
• Phase: N/A
• Start date: August 26, 2016
• Est. completion date: July 17, 2019

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. This research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.

Description:

Migraine is a common and disabling pain condition. Affective/cognitive processes, such as pain catastrophizing and emotional reactivity, often play a major role in migraine pain and disability. These processes may be just as important to target as the sensory aspect given their impact on outcomes and disability. Because of this cognitive/affective load that builds over time in migraine, we hypothesize A) migraineurs perceive affective pain processing differently than non-migraineurs and B) mind/body therapies that target these factors may be especially beneficial and may differentially impact the affective component of migraine pain. Evidence shows that meditation decreases affective (e.g., pain unpleasantness) over sensory (e.g., pain intensity) response to experimental pain and reduces pain by engaging brain regions important for cognitive and affective modulation of pain. By measuring both experimental and clinical pain, the study team will be able to test these hypotheses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Diagnosis of migraine; =18yo; =1 yr of migraines; 4-20 days/month with migraines; able and willing to participate in 8 weekly sessions and daily homework 30-45min Exclusion Criteria: Current regular (weekly or more often) practice of meditation; any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.); other non-migraine chronic pain condition (e.g., fibromyalgia, low back pain, etc.) or sensory abnormalities (e.g., neuropathy, Raynaud's, etc.); diagnosis of medication overuse headache; volunteers with no pain ratings to frankly noxious stimuli (temperatures > 49°C) or excessive responses to threshold temperatures (~43°C); current or planned pregnancy or breastfeeding, any new medication started within 4 weeks of screening visit; unwilling to maintain stable current medication dosages for duration of trial; failure to complete baseline headache logs.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Mindfulness Based Stress Reduction
MBSR is a standardized course in mindfulness mediation and yoga. The participants will meet weekly for 8 weeks for 2.5 hours, plus a "mindfulness retreat day" (approximately 6 hours) after the 6th class [9 total classes.] Mindfulness is cultivated through meditation, body scan (sequential attention to parts of the body), and mindful movement (bodily awareness during gentle stretching, based on yoga). The instructor also gives information about stress and stress relief.
• Migraine/stress Education
The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014 Oct;54(9):1484-95. doi: 10.1111/head.12420. Epub 2014 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency of Migraine Days Per Month From Baseline	Change in frequency of migraine days from baseline: A migraine day is defined as a calendar day (00:00 to 23:59) when the patient reports 4 or more continuous hours of a moderate to severe headache (rating of 6-10 on 0-10 pain intensity scale) and/or they treated a headache with abortive medication; tracked with headache logs.	Baseline and immediately post-intervention (12 weeks)
Secondary	Change in Frequency of Migraine Days From Baseline	Change in frequency of migraine days from baseline: A migraine day is defined as a calendar day (00:00 to 23:59) when the patient reports 4 or more continuous hours of a moderate to severe headache (rating of 6-10 on 0-10 pain intensity scale) and/or they treated a headache with abortive medication; tracked with headache logs	3 months post-intervention
Secondary	Change in Frequency of Headache Days From Baseline	Change in frequency of any day with a headache tracked with headache logs	Baseline to Immediately post-intervention (12 weeks)
Secondary	Change in Headache Duration From Baseline to 12 Weeks	Modeled change in headache duration from baseline 4 weeks to weeks 8-12 by calculating the duration (in hours) of each headache attack and using a multivariable linear mixed model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.	From baseline to Immediately post-intervention (12 weeks)
Secondary	Change in Migraine Severity-pain Intensity From Baseline to Week 12	change in headache severity-pain intensity from baseline 4 weeks to weeks 8-12. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). We calculated the pain intensity of each headache attack and used a multivariable linear model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.	baseline to Week 12
Secondary	Change in Headache Severity-pain Intensity From Baseline to Week 12	Modeled change in headache severity-pain intensity from baseline 4 weeks to weeks 8-12. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). Higher scores mean a worse outcome in terms of pain intensity.	Baseline and 12 weeks
Secondary	Change in Migraine Severity-pain Unpleasantness From Baseline	Change in migraine severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)	Baseline to 6 months post-intervention
Secondary	Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks	Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 8-12 (tracked with headache logs).	Baseline and 12 weeks
Secondary	Percent Change in Score in Response to Experimental Heat Pain on Pain Intensity Measure From Baseline (0-10) Visual Analogue Scale (VAS Scale ) to 12 Weeks	Using a 10 cm sliding visual analogue scale, participants quantified intensity (from "no pain sensation" to "most intense imaginable"), at baseline and at 12 weeks for each of 6 measures at 49 °C. A multivariable linear mixed model was used to model the percent change from baseline in perceived pain intensity at each visit for each of 6 measures at 49 °C. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.	Baseline to week 12
Secondary	Percent Change in Response Score to Experimental Heat Pain on Pain Unpleasantness Measure From Baseline (0-10) Visual Analogue Scale (VAS Scale) From Baseline to 12 Weeks	Using a 10 cm sliding visual analogue scale, participants quantified unpleasantness (from "not at all unpleasant" to "most unpleasant imaginable"). Participants rated perceived pain unpleasantness at baseline and at 12 weeks for each of 6 measures at 49 °C. A multivariable linear mixed model was used to model the percent change from baseline in perceived pain intensity at each visit for each of 6 measures at 49 °C. Change scores were modeled as a function of treatment group and visit, controlling for baseline. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.	Baseline to week 12
Secondary	Change in Experimental Heat Pain Threshold From Baseline to Week 12	Change in Experimental Heat Pain Threshold From Baseline to 12 weeks	Baseline to week 12
Secondary	Change in Headache-related Disability From Baseline	Change in headache-related disability from baseline (Migraine Disability Assessment (MIDAS)-one month) Score range is 0-21+; 0 to 5: MIDAS grade I, little or no disability 6 to 10: MIDAS grade II, mild disability 11 to 20: MIDAS grade III, moderate disability 21 or higher: MIDAS grade IV, severe disability	Baseline to Immediately post-intervention
Secondary	Change in Headache Disability Scores From Baseline	Change in headache-related disability from baseline ( Headache Impact Test (HIT)-6); Headache impact severity level can be categorized using score ranges based on the HIT-6 interpretation guide (29), The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78). Range is 10-78 with higher score = more disability	Baseline to Immediately post-intervention
Secondary	Change in Headache-related Quality of Life Scores From Baseline	Change in headache-related quality of life from baseline (Migraine Specific Quality of Life, v2.1); The Migraine Specific Quality of Life (MSQoL) is a patient-reported outcome measure (PRO or PROM) which assesses the quality of life of migraineurs. It is a 25-item questionnaire which is filled out by the patient and is used to determine how the patient's life has been affected by their migraines - larger scores reflecting greater impact - scores = 49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact, and scores = 60 indicate severe impact	Baseline to Immediately post-intervention
Secondary	Change in Mindfulness Scores From Baseline	Change in mindfulness from baseline (Five-Facet Mindfulness Scale) - measures the trait-like tendency to be mindful in daily life. It is comprised of the following five related facets: observing, describing, acting with awareness, nonjudging, and nonreactivity - The 39 items of the Five Facet Mindfulness Questionnaire (FFMQ) are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true).; Higher scores reflect higher mindfulness scores; Range 39-195; Subscales are summed for the total score	Baseline to Immediately post-intervention
Secondary	Change in Emotion Regulation Scores From Baseline to 12 Weeks	Change in emotion regulation from baseline (Difficulty Emotion Regulation Scale), Higher scores suggest greater problems with emotion regulation - The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation	Baseline to week 12
Secondary	Change in Pain Catastrophizing From Baseline to 12 Weeks	Change in pain catastrophizing from baseline (Pain Catastrophizing Scale); Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52 - higher scores relating to more pain	Baseline to Immediately post-intervention (12 weeks)
Secondary	Change in Pain Acceptance From Baseline to 12 Weeks	Change in pain acceptance from baseline (Chronic Pain Acceptance Questionnaire), higher scores reflect higher levels of pain acceptance; total range 0-156.	Baseline and week 12
Secondary	Change in Perceived Stress From Baseline to 12 Weeks	Change in perceived stress from baseline (Perceived Stress Scale); Score Range: 0-40 with lower scores reflecting lower perceived stress. Ranges: 0-13 Low Stress; 14-26 Moderate Stress; 27-40 High perceived stress.	Baseline and week 12
Secondary	Change in Depression Scores From Baseline	Change in depression from baseline (Patient health-related Questionnaire-depression module, PHQ-9); Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression - The Patient Health Questionnaire-9 (PHQ-9) total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; = 20 as severe depression)	Baseline to Immediately post-intervention
Secondary	Change in Anxiety Scores From Baseline	Change in anxiety from baseline (Generalized Anxiety Disorder (GAD-7). Higher Scores suggest a greater level of anxiety.; Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)	Baseline to Immediately post-intervention
Secondary	Change in Self-efficacy Scores From Baseline	Change in self-efficacy from baseline (Headache Management Self-Efficacy scale). Higher scores reflect more self-efficacy.; The Headache Self-Efficacy Scale is a 51 item scale designed specifically for recurrent headache sufferers. It assesses individuals' belief that they are able to do the things necessary to prevent a moderately painful headache when confronted with personally relevant headache precipitants - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise	Baseline to Immediately post-intervention
Secondary	Change in Hope Scores From Baseline to 12 Weeks	Change in hope from baseline (Herth Hope Index); Higher scores suggest higher levels of "Hope."; Herth Hope Scale (HHS) is a measure that attempts to capture the multidimensional aspects of hope. This is a 4-point summated rating scale.; Each item in the 30-item instrument is scored on a scale from 0 to 3, a score of 3 indicates that the item often applies and a score of 0 indicates that the statement never applies to the respondent. Summative scores can range from 0 to 90; higher scores denote greater hope. In terms of item order, no two consecutive items are from the same subscale.	Baseline and week 12
Secondary	Change in Optimism From Baseline to 12 Weeks	Change in optimism from baseline (Life Orientation Test-revised); Higher scores indicate greater levels of optimism.; The Life Orientation Test (LOT) was developed to measure individual differences in optimism versus pessimism. Response options: 5-point Likert scale ranging from 0, "Strongly disagree" to 4, "Strongly agree". Total score: Items are summed, yielding a range from 0 to 32.	Baseline to week 12
Secondary	Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12	Change in sleep from baseline measured with by NIH Promis Sleep Disturbance; Higher scores indicate greater severity of sleep disturbance; Range from 8-40.	Baseline and week 12
Secondary	Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to 12 Weeks	Change in sleep from baseline measured with by NIH Promis Sleep Disturbance; Higher scores indicate greater severity of sleep disturbance; Range from 8-40.	Baseline and week 12
Secondary	Change in Global Health From Baseline to 12 Weeks	Change in global health from baseline (NIH Promis Global Health-1st question); Range 0-5, 5 highest.	Baseline and week 12
Secondary	Change in Social Connectedness From Baseline to 12 Weeks	Change in social connectedness from baseline (Social Connectedness Scale-revised); Higher scores reflect a higher level of social connection.; It is on a likert scale with 1 being strongly disagree to 6 being strongly agree.	Baseline to week 12
Secondary	Change in Flourishing From Baseline to 12 Weeks	Change in flourishing from baseline (Flourishing scale); Higher scores represents a person with many psychological resources and strength; Range from 8-56.	Baseline and week 12
Secondary	Change in Resilience Scores From Baseline to 12 Weeks	Change in resilience from baseline (Brief Resilience scale); higher scores indicate greater levels of resilience; scores range from 6-30	Baseline to week 12
Secondary	Change in Allodynia From Baseline to 12 Weeks	Change in allodynia from baseline (Allodynia Symptom Checklist), score range 0-24, 0-2 none; 3-5 mild; 6-8 moderate; 9+ severe; Cutaneous allodynia (CA) scale defining no CA (scores 0-2), mild CA (3-5), moderate CA (6-8), and severe CA (=9).	Baseline to week 12
Secondary	Change in Number of Migraine Days From Baseline	Change in frequency of migraine days from baseline: A migraine day is defined as a calendar day (00:00 to 23:59) when the patient reports 4 or more continuous hours of a moderate to severe headache (rating of 6-10 on 0-10 pain intensity scale) and/or they treated a headache with abortive medication; tracked with headache logs	Baseline to 6 months post-intervention
Secondary	Change in Number of Headache Days From Baseline	Change in frequency of any day with a headache tracked with headache logs	Baseline to 3 Months post-intervention
Secondary	Change in Number of Headache Days From Baseline	Change in frequency of any day with a headache tracked with headache logs	Baseline to 6 Months post-intervention
Secondary	Change in Headache Duration From Baseline to 24 Weeks	Modeled change in headache duration from baseline 4 weeks to weeks 20-24 by calculating the duration (in hours) of each headache attack	Baseline to 3 Months post-intervention (24 weeks)
Secondary	Change in Headache Duration From Baseline to 36 Weeks	Modeled change in headache duration from baseline 4 weeks to weeks 32-36 by calculating the duration (in hours) of each headache attack	Baseline to 6 Months post-intervention (36 weeks)
Secondary	Change in Headache Severity-pain Intensity From Baseline to 24 Weeks	change in headache severity-pain intensity from baseline 4 weeks to weeks 20-24 weeks. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). We calculated the pain intensity of each headache attack and used a multivariable linear mixed model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.	Baseline and 24 weeks
Secondary	Change in Headache Severity-pain Intensity From Baseline to 36 Weeks	change in headache severity-pain intensity from baseline 4 weeks to weeks 32-36. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). We calculated the pain intensity of each headache attack and used a multivariable linear mixed model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.	Baseline and 36 weeks
Secondary	Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks	Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 20-24 (tracked with headache logs).	Baseline and 24 weeks
Secondary	Change in Headache Severity-pain Unpleasantness From Baseline to Week 36	Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 32-36 (tracked with headache logs).	Baseline and week 36