Clinical trial NCT02695498: Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
Official title: Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine with aura
migraine without aura
pain
controls
mind-body
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-03-01
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Frequency of Migraine Days Per Month From Baseline
timeFrame: Baseline and immediately post-intervention (12 weeks)
Secondary outcomes:
measure: Change in Frequency of Migraine Days From Baseline
timeFrame: 3 months post-intervention
measure: Change in Frequency of Headache Days From Baseline
timeFrame: Baseline to Immediately post-intervention (12 weeks)
measure: Change in Headache Duration From Baseline to 12 Weeks
timeFrame: From baseline to Immediately post-intervention (12 weeks)
measure: Change in Migraine Severity-pain Intensity From Baseline to Week 12
timeFrame: baseline to Week 12
measure: Change in Headache Severity-pain Intensity From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Change in Migraine Severity-pain Unpleasantness From Baseline
timeFrame: Baseline to 6 months post-intervention
measure: Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline to week 12
measure: 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
timeFrame: Baseline to week 12
measure: Change in Experimental Heat Pain Threshold From Baseline to Week 12
timeFrame: Baseline to week 12
measure: Change in Headache-related Disability From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Headache Disability Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Headache-related Quality of Life Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Mindfulness Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Emotion Regulation Scores From Baseline to 12 Weeks
timeFrame: Baseline to week 12
measure: Change in Pain Catastrophizing From Baseline to 12 Weeks
timeFrame: Baseline to Immediately post-intervention (12 weeks)
measure: Change in Pain Acceptance From Baseline to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Perceived Stress From Baseline to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Depression Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Anxiety Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Self-efficacy Scores From Baseline
timeFrame: Baseline to Immediately post-intervention
measure: Change in Hope Scores From Baseline to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Optimism From Baseline to 12 Weeks
timeFrame: Baseline to week 12
measure: Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12
timeFrame: Baseline and week 12
measure: Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Global Health From Baseline to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Social Connectedness From Baseline to 12 Weeks
timeFrame: Baseline to week 12
measure: Change in Flourishing From Baseline to 12 Weeks
timeFrame: Baseline and week 12
measure: Change in Resilience Scores From Baseline to 12 Weeks
timeFrame: Baseline to week 12
measure: Change in Allodynia From Baseline to 12 Weeks
timeFrame: Baseline to week 12
measure: Change in Number of Migraine Days From Baseline
timeFrame: Baseline to 6 months post-intervention
measure: Change in Number of Headache Days From Baseline
timeFrame: Baseline to 3 Months post-intervention
measure: Change in Number of Headache Days From Baseline
timeFrame: Baseline to 6 Months post-intervention
measure: Change in Headache Duration From Baseline to 24 Weeks
timeFrame: Baseline to 3 Months post-intervention (24 weeks)
measure: Change in Headache Duration From Baseline to 36 Weeks
timeFrame: Baseline to 6 Months post-intervention (36 weeks)
measure: Change in Headache Severity-pain Intensity From Baseline to 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Headache Severity-pain Intensity From Baseline to 36 Weeks
timeFrame: Baseline and 36 weeks
measure: Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change in Headache Severity-pain Unpleasantness From Baseline to Week 36
timeFrame: Baseline and week 36
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rebecca E Wells, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wells RE, O'Connell N, Pierce CR, Estave P, Penzien DB, Loder E, Zeidan F, Houle TT. Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. JAMA Intern Med. 2021 Mar 1;181(3):317-328. doi: 10.1001/jamainternmed.2020.7090.