Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

NCT ID: NCT02695498

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-26
• Study Completion Date: 2019-07-17

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mindfulness Based Stress Reduction

Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: OTHER

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

This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Group Type: EXPERIMENTAL

Migraine/stress Education

Intervention Type: OTHER

The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Interventions

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.

Intervention Type: OTHER

Migraine/stress Education

The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca E Wells, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25041058 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33315046 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23AT008406

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00027845-B

Identifier Type: -

Identifier Source: org_study_id