Educational Intervention in Patients With Migraine

Migraine Clinical Trial

— M01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381924
• Other study ID #: MIGRAINE01
• Status: Completed
• Phase: N/A
• First received: December 14, 2017
• Last updated: December 21, 2017
• Start date: August 1, 2013
• Est. completion date: May 30, 2016

Study information

• Verified date: December 2017
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Educational programme
In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
• Routine clinical practice
Patients allocated to the control group will only receive the drugs used in the habitual clinical practice

Locations

Country	Name	City	State
Spain	Iñaki Aguirrezabal Bazterrica	Vitoria-gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	costs associated with migraine-related treatment	Both preventive medication and medication for treating migraine attacks	12 months