Clinical trial NCT02768233: Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
Official title: Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Headache Disorders
Medication-overuse Headache
Keywords: Medication-overuse Headache
Educational Programme
Personality Profiles
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache frequency measured by self-reported headache diary on number of days with headache previous month
timeFrame: baseline-36 weeks follow-up
Secondary outcomes:
measure: NEO-FFI-3 personality test
timeFrame: Baseline
measure: Coping Strategies
timeFrame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
measure: Pain Intensity
timeFrame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
measure: Bothersomeness
timeFrame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
measure: Patient satisfaction
timeFrame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
measure: Medication intake
timeFrame: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Hospital of South West Jutland, Denmark
name: Louise S. Mose, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mose LS, Pedersen SS, Jensen RH, Gram B. Medication-overuse headache: The effect of a patient educational programme-A randomized controlled trial. Eur J Pain. 2020 Feb;24(2):435-447. doi: 10.1002/ejp.1500. Epub 2019 Nov 21.