Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Migraine

Treatments

Other: Mindfulness Based Stress Reduction
Other: Migraine/stress Education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02695498
K23AT008406
IRB00027845-B

Details and patient eligibility

About

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.

Full 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.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

89 participants in 2 patient groups

Mindfulness Based Stress Reduction
Experimental group
Description:
Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.
Treatment:
Other: Mindfulness Based Stress Reduction
Migraine/stress Education
Experimental group
Description:
This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Treatment:
Other: Migraine/stress Education

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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