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

Primary Purpose

Secondary Headache Disorders, Medication-overuse Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational programme
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Headache Disorders focused on measuring Medication-overuse Headache, Educational Programme, Personality Profiles

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Educational programme

    Standard treatment

    Arm Description

    Group 1: Educational programme + standard treatment

    Standard treatment

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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)
    Coping Strategies
    CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
    Pain Intensity
    VAS (0: No pain, 10: Pain as bad as it can be)
    Bothersomeness
    VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
    Patient satisfaction
    Questionnarire
    Medication intake
    self reported intake (type, name of medication, dosis)

    Full Information

    First Posted
    May 9, 2016
    Last Updated
    January 2, 2023
    Sponsor
    Hospital of South West Jutland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02768233
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2015 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital of South West Jutland

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Headache Disorders, Medication-overuse Headache
    Keywords
    Medication-overuse Headache, Educational Programme, Personality Profiles

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational programme
    Arm Type
    Experimental
    Arm Description
    Group 1: Educational programme + standard treatment
    Arm Title
    Standard treatment
    Arm Type
    No Intervention
    Arm Description
    Standard treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational programme
    Intervention Description
    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 Outcome Measure Information:
    Title
    Headache frequency measured by self-reported headache diary on number of days with headache previous month
    Time Frame
    baseline-36 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    NEO-FFI-3 personality test
    Description
    self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)
    Time Frame
    Baseline
    Title
    Coping Strategies
    Description
    CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
    Time Frame
    Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
    Title
    Pain Intensity
    Description
    VAS (0: No pain, 10: Pain as bad as it can be)
    Time Frame
    Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
    Title
    Bothersomeness
    Description
    VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
    Time Frame
    Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
    Title
    Patient satisfaction
    Description
    Questionnarire
    Time Frame
    Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
    Title
    Medication intake
    Description
    self reported intake (type, name of medication, dosis)
    Time Frame
    baseline, Post intervention (16 weeks) and Follow-up (36 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Louise S. Mose, MHS
    Organizational Affiliation
    Hospital of South West Jutland, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31661579
    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.
    Results Reference
    derived

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