N/A N=89 Randomized Quadruple-blind Treatment

Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT02695498 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Change in Frequency of Migraine Days Per Month From Baseline — -1.6; -2.0 number of days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness Based Stress Reduction (Other); Migraine/stress Education (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Frequency of Migraine Days Per Month From Baseline	-1.6; -2.0	—
SECONDARY Change in Frequency of Migraine Days From Baseline	-2.2; -1.98	—
SECONDARY Change in Frequency of Headache Days From Baseline	—	—
SECONDARY Change in Headache Duration From Baseline to 12 Weeks	—	—
SECONDARY Change in Migraine Severity-pain Intensity From Baseline to Week 12	-0.142; -.177	—
SECONDARY Change in Headache Severity-pain Intensity From Baseline to Week 12	0.142; -0.177	—
SECONDARY Change in Migraine Severity-pain Unpleasantness From Baseline	—	—
SECONDARY Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks	.1745; -0.0884	—
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	-36.3; 13.5	—
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	-30.4; 11.2	—
SECONDARY Change in Experimental Heat Pain Threshold From Baseline to Week 12	0.096; 0.162	—
SECONDARY Change in Headache-related Disability From Baseline	-7.6; -1.7	—
SECONDARY Change in Headache Disability Scores From Baseline	-6.5; -1.2	—
SECONDARY Change in Headache-related Quality of Life Scores From Baseline	33.6; 38.6	—
SECONDARY Change in Mindfulness Scores From Baseline	4.1; 0.4	—
SECONDARY Change in Emotion Regulation Scores From Baseline to 12 Weeks	-3.4; 0.46	—
SECONDARY Change in Pain Catastrophizing From Baseline to 12 Weeks	-6.4; -0.7	—
SECONDARY Change in Pain Acceptance From Baseline to 12 Weeks	5.36; 1.89	—
SECONDARY Change in Perceived Stress From Baseline to 12 Weeks	-2.65; -1.78	—
SECONDARY Change in Depression Scores From Baseline	-1.0; 0.6	—
SECONDARY Change in Anxiety Scores From Baseline	-1.6; -0.2	—
SECONDARY Change in Self-efficacy Scores From Baseline	15.6; 6.8	—
SECONDARY Change in Hope Scores From Baseline to 12 Weeks	0.165; -0.046	—
SECONDARY Change in Optimism From Baseline to 12 Weeks	-0.771; -0.171	—
SECONDARY Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12	-1.68; 0.9784	—
SECONDARY Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to 12 Weeks	—	—
SECONDARY Change in Global Health From Baseline to 12 Weeks	3.48; 3.23	—
SECONDARY Change in Social Connectedness From Baseline to 12 Weeks	-1.00; -.447	—
SECONDARY Change in Flourishing From Baseline to 12 Weeks	1.07; -0.10	—
SECONDARY Change in Resilience Scores From Baseline to 12 Weeks	0.238; -0.486	—
SECONDARY Change in Allodynia From Baseline to 12 Weeks	—	—
SECONDARY Change in Number of Migraine Days From Baseline	-2.2; -2.7	—
SECONDARY Change in Number of Headache Days From Baseline	-3.2; -4.1	—
SECONDARY Change in Number of Headache Days From Baseline	-3.2; -4.1	—
SECONDARY Change in Headache Duration From Baseline to 24 Weeks	—	—
SECONDARY Change in Headache Duration From Baseline to 36 Weeks	—	—
SECONDARY Change in Headache Severity-pain Intensity From Baseline to 24 Weeks	0.111; -0.1666	—
SECONDARY Change in Headache Severity-pain Intensity From Baseline to 36 Weeks	0.1049; 0.047	—
SECONDARY Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks	-0.107; -0.046	—
SECONDARY Change in Headache Severity-pain Unpleasantness From Baseline to Week 36	-0.0811; 0.0977	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02695498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.