Medication-overuse Headache, Secondary Headache Disorders
Conditions
Keywords
Medication-overuse Headache, Educational Programme, Personality Profiles
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.
Interventions
BEHAVIORALEducational programme
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.
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache frequency measured by self-reported headache diary on number of days with headache previous month | baseline-36 weeks follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Coping Strategies | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always) |
| Pain Intensity | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | VAS (0: No pain, 10: Pain as bad as it can be) |
| Bothersomeness | Baseline, Post intervention (16 weeks), Follow-up (36 weeks) | VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be) |
| 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) |
Outcome results
None listed