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

NCT ID: NCT02768233

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-15

Study Completion Date

2019-01-31

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.

Conditions

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Secondary Headache Disorders Medication-overuse Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Educational programme

Group 1: Educational programme + standard treatment

Group Type EXPERIMENTAL

Educational programme

Intervention Type 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.

Standard treatment

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Louise Schlosser Mose

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louise S. Mose, MHS

Role: PRINCIPAL_INVESTIGATOR

Hospital of South West Jutland, Denmark

References

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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.

Reference Type DERIVED
PMID: 31661579 (View on PubMed)

Other Identifiers

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S-20140114

Identifier Type: -

Identifier Source: org_study_id

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