NCT03381924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

December 14, 2017

Last Update Submit

December 21, 2017

Conditions

Migraine

Keywords

Migraine disordersEducational modelsNeuroscience

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intensity and frequency of the pain

    12 months

  • Degree to which activities of daily life were limited by migraine

    12 months

  • costs associated with migraine-related treatment

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.

Other: Educational programme

Control group

PLACEBO COMPARATOR

Routine clinical practice

Other: Routine clinical practice

Interventions

Educational programmeOTHER

In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.

Intervention group
Routine clinical practiceOTHER

Patients allocated to the control group will only receive the drugs used in the habitual clinical practice

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iñaki Aguirrezabal Bazterrica

Vitoria-Gasteiz, Alava, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • IÑAKI AGUIRREZABAL

    Basque Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Practitioner

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 22, 2017

Study Start

August 1, 2013

Primary Completion

May 30, 2016

Study Completion

May 30, 2016

Last Updated

December 22, 2017

Record last verified: 2017-12

Locations

ES(1)