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

Abstract

BackgroundChronic 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/DesignA 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.DiscussionThere 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 registrationClinicalTrials.gov identifier: NCT01314768

Predictors of successful primary care detoxification treatment for medication-overuse headache

“…16 Thus, we suggest our main results to be both representative and valid. 16 Thus, we suggest our main results to be both representative and valid.…”

“…7,11,16 No power calculations were made for the rest of the outcomes. 7,11,16 No power calculations were made for the rest of the outcomes.…”

“…Further details of the methods have been published elsewhere. 7,8,16 A short screening questionnaire for headache and medication use was posted to all 18-to 50-year-old patients (n=25 486) on the 50 participating GPs' patient lists. The response rate of the screening questionnaire was 42%.…”

“…Power calculations performed on the basis of the primary outcomes in the first part of the intervention study suggested 18 patients per arm to be sufficient (80% power, 5% significance, intraclass correlation coefficient 0.5, effect size based on previous study). 7,11,16 No power calculations were made for the rest of the outcomes.…”

“…Strengths are as follows: the design, the external and internal validity with inclusion of representative GPs and patients from a large population sample. The methods have been thoroughly discussed elsewhere 7,8,16,23. The methods have been thoroughly discussed elsewhere 7,8,16,23.…”