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

January 2, 2023 updated by: Louise Schlosser Mose, Hospital of South West Jutland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational programme
Group 1: Educational programme + standard treatment
Behavioral: 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.
No Intervention: Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache frequency measured by self-reported headache diary on number of days with headache previous month
Time Frame: baseline-36 weeks follow-up
baseline-36 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
Coping Strategies
Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
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)
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Bothersomeness
Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Patient satisfaction
Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Questionnarire
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Medication intake
Time Frame: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
self reported intake (type, name of medication, dosis)
baseline, Post intervention (16 weeks) and Follow-up (36 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of South West Jutland

Investigators

  • Principal Investigator: Louise S. Mose, MHS, Hospital of South West Jutland, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20140114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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