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BMC Neurology

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Open Access 01-12-2012 | Study protocol

Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

Authors: Espen Saxhaug Kristoffersen, Jørund Straand, Jūratė Saltytė Benth, Michael Bjørn Russell, Christofer Lundqvist

Published in: BMC Neurology | Issue 1/2012

Abstract

Background

Chronic headache (headache ≥ 15 days/month for at least 3 months) affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH) can be identified by using the Severity of Dependence Scale (SDS). A “brief intervention” scheme (BI) has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI) scheme to be used for MOH in primary care.

Methods/Design

A double-blinded cluster randomised parallel controlled trial (RCT) of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months.

Discussion

There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication withdrawal method. To our knowledge this is the first RCT of structured non-pharmacological MOH treatment in primary care. Results may hold the potential of offering an instrument for treating MOH patients in the general population by GPs.

Trial registration

ClinicalTrials.gov identifier: NCT01314768

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/12/70/prepub

Title: Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care
Authors: Espen Saxhaug Kristoffersen
Jørund Straand
Jūratė Saltytė Benth
Michael Bjørn Russell
Christofer Lundqvist
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: BMC Neurology / Issue 1/2012
Electronic ISSN: 1471-2377
DOI: https://doi.org/10.1186/1471-2377-12-70

At a glance: The STEP trials

Springer Medicine

Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

Abstract

Background

Methods/Design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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