Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
1 other identifier
interventional
98
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2015
CompletedFirst Submitted
Initial submission to the registry
May 9, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJanuary 4, 2023
January 1, 2023
2.7 years
May 9, 2016
January 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache frequency measured by self-reported headache diary on number of days with headache previous month
baseline-36 weeks follow-up
Secondary Outcomes (6)
NEO-FFI-3 personality test
Baseline
Coping Strategies
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Pain Intensity
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Bothersomeness
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Patient satisfaction
Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
- +1 more secondary outcomes
Study Arms (2)
Educational programme
EXPERIMENTALGroup 1: Educational programme + standard treatment
Standard treatment
NO INTERVENTIONStandard treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment
- Mental health disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31661579DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise S. Mose, MHS
Hospital of South West Jutland, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
May 9, 2016
First Posted
May 11, 2016
Study Start
October 15, 2015
Primary Completion
July 1, 2018
Study Completion
January 1, 2019
Last Updated
January 4, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share