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NCT Number: NCT02768233

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

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.

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Key information

Conditions

Secondary Headache Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Medication-overuse Headache Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Headache frequency measured by self-reported headache diary on number of days with headache previous month

    Time frame: baseline-36 weeks follow-up

Secondary outcomes

  1. NEO-FFI-3 personality test

    Time frame: Baseline

    self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)

  2. Coping Strategies

    Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)

    CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)

  3. Pain Intensity

    Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)

    VAS (0: No pain, 10: Pain as bad as it can be)

  4. Bothersomeness

    Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)

    VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)

  5. Patient satisfaction

    Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)

    Questionnarire

  6. Medication intake

    Time frame: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)

    self reported intake (type, name of medication, dosis)

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 11, 2016
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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