Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment

Study Overview
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Brief Summary
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The aim of this study is to evaluate the influence of personality profiles in patients with MOH and to evaluate the effect of a custom-made educational programme as an add-on to standard treatment as compared to standard treatment alone in MOH patients using a randomized controlled trial (RCT) design.

Detailed Description
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Worldwide, two percent of the population suffers from medication-overuse headache (MOH), a paradox condition where the headache is caused by overuse of headache medication. Common treatment is withdrawal, but there is no consensus on what constitutes the best treatment. The study consists of a RCT with MOH patients randomized to standard treatment versus standard treatment + a 12-week, 6-session educational programme as add-on. The programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. Primary endpoint: Headache frequency measured by self-reported headache diary on number of days with headache pre-vious month. Secondary endpoints: NEO-FFI-3 personality test, coping strategies, pain intensity, bothersomeness, patient satis-faction and reported medication intake.

Official Title
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Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment

Conditions
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Secondary Headache Disorders, Medication-overuse Headache

Intervention / Treatment
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* Behavioral: Educational programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with medication-overuse headache (MOH) by neurologist (The International Classification of headache Disorders). Completed withdrawal (hospitalized of 8 days or at home). Age 18-65 years Understand and speak Danish Exclusion Criteria: Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment Mental health disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational programme<br>Group 1: Educational programme + standard treatment | Behavioral: Educational programme<br>* The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.<br>|
| No Intervention: Standard treatment<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency measured by self-reported headache diary on number of days with headache previous month |  | baseline-36 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEO-FFI-3 personality test | self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) | Baseline | 
| Coping Strategies | CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always) | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | 
| Pain Intensity | VAS (0: No pain, 10: Pain as bad as it can be) | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | 
| Bothersomeness | VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be) | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | 
| Patient satisfaction | Questionnarire | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | 
| Medication intake | self reported intake (type, name of medication, dosis) | baseline, Post intervention (16 weeks) and Follow-up (36 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication-overuse Headache, Educational Programme, Personality Profiles