Clinical trial NCT03381924: Educational Intervention in Patients With Migraine
Official title: Effectiveness of a Group Educational Intervention in Patients With Migraine: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine disorders
Educational models
Neuroscience
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2017-12-22
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Migraine-related disability given by the MIDAS score
timeFrame: 12 months
Secondary outcomes:
measure: Intensity and frequency of the pain
timeFrame: 12 months
measure: Degree to which activities of daily life were limited by migraine
timeFrame: 12 months
measure: costs associated with migraine-related treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Iñaki Aguirrezabal Bazterrica
state: Alava
Study officials:
affiliation: Basque Health Service
name: IÑAKI AGUIRREZABAL
role: PRINCIPAL_INVESTIGATOR
References: