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

Not Applicable

Completed

• Conditions: Medication-overuse Headache; Secondary Headache Disorders
• Interventions: Behavioral: Educational programme

• Registration Number: NCT02768233
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10-15
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2018-07-01
• Study Completion: 2019-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational programme	Educational programme	Group 1: Educational programme + standard treatment

Primary Outcome Measures

Name	Time	Method
Headache frequency measured by self-reported headache diary on number of days with headache previous month	baseline-36 weeks follow-up

Secondary Outcome Measures

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