Educational Intervention in Patients With Migraine (M01)

Effectiveness of a Group Educational Intervention in Patients With Migraine: a Randomised Controlled Trial

Introduction: Despite the numerous pharmacological treatment options available for migraine attacks and for the prevention of thereof, less than 30% of patients with migraine are highly satisfied with their current treatment.

In recent decades, there has been a radical change in the way we view pain, thanks to developments in neuroscience. It is currently considered that pain does not originate in the peripheral nociceptors, but rather in a network of brain regions (the pain neuromatrix), the synchronous activation of which is necessary and sufficient to generate the perception of pain. Migraine may be the expression of this exaggerated perception of threat, a perception that, from a cultural learning perspective, it may be possible to modify by adjusting beliefs and behaviours that favour the onset of an attack.

The aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of Alava.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Other: Educational programme; Other: Routine clinical practice

Detailed Description

The aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of Alava.

After recruitment, patients were interviewed by the research team members in charge of the assessments. In these interviews, data were collected on the following: demographic characteristics, beliefs regarding migraine, coping strategies for migraine attacks, the MIDAS questionnaire (16), medication taken, work leave, emergency department attendances and limitation of daily activities due to migraine, during the previous 3 months.

Subsequently, we carried out further assessments over the telephone after 3, 6 and 12 months. Very few studies assessing preventive treatments for migraine have performed assessments 12 months after initiating prophylactic treatment, most having followed-up patients for 6 months at most. We believe, however, it is necessary to continue assessments for at least 1 year to properly test the efficacy of treatment for chronic illnesses like migraine. The individuals carrying out the assessment were blinded to group allocation. The clinical follow-up was the same for both groups, the only difference in their management being the educational intervention itself.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-gasteiz, Alava, Spain
      • Iñaki Aguirrezabal Bazterrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Belong to one of these health centres of primary care: San Martín, Sansomendi, Lakuarriaga, Gazalbide and Zabalgana,
• Diagnosed with migraine (ICD-9-CM Diagnosis Code 346) who had at least one migraine attack every month despite treatment.

Exclusion Criteria:

• We excluded patients with mental illness, cognitive impairment or language deficits that might hinder completion of follow-up and patients that would not be able to attend to all the sessions of the intervention or had received training as part of the previous pilot study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.	Other: Educational programme; In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
Placebo Comparator: Control group; Routine clinical practice	Other: Routine clinical practice; Patients allocated to the control group will only receive the drugs used in the habitual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine-related disability given by the MIDAS score	The sum of responses to five questions on days missed or with reduced productivity at work/school, at home and in leisure activities.I If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity and frequency of the pain	Measured using the two supplementary questions of the MIDAS, the two supplementary questions of the MIDAS. If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.	12 months
Degree to which activities of daily life were limited by migraine	Measured using an ad hoc scale with six possible answers: not at all, very little, little, quite a lot, a lot, and totally.	12 months
costs associated with migraine-related treatment	Both preventive medication and medication for treating migraine attacks	12 months

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: IÑAKI AGUIRREZABAL, Basque Health Service

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Neuroscience; Educational models; Migraine disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: MIGRAINE01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No