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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational programme | Experimental | Group 1: Educational programme + standard treatment |
|
| Standard treatment | No Intervention | Standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational programme | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise S. Mose, MHS | Hospital of South West Jutland, Denmark | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31661579 | Derived | 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. |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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) |