Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
116 participants
INTERVENTIONAL
2013-08-01
2016-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
Educational programme
In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
Control group
Routine clinical practice
Routine clinical practice
Patients allocated to the control group will only receive the drugs used in the habitual clinical practice
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed with migraine (ICD-9-CM Diagnosis Code 346) who had at least one migraine attack every month despite treatment.
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Basque Health Service
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iñaki Aguirrezabal Bazterrica
General Practitioner
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
IÑAKI AGUIRREZABAL
Role: PRINCIPAL_INVESTIGATOR
Basque Health Service
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Iñaki Aguirrezabal Bazterrica
Vitoria-Gasteiz, Alava, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MIGRAINE01
Identifier Type: -
Identifier Source: org_study_id