Clinical Trials Directory

Trials / Completed

CompletedNCT03381924

Educational Intervention in Patients With Migraine

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
116 (actual)
Sponsor
Basque Health Service · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEREducational programmeIn each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
OTHERRoutine clinical practicePatients allocated to the control group will only receive the drugs used in the habitual clinical practice

Timeline

Start date
2013-08-01
Primary completion
2016-05-30
Completion
2016-05-30
First posted
2017-12-22
Last updated
2017-12-22

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03381924. Inclusion in this directory is not an endorsement.