Secondary Headache DisordersNCT02768233
Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
A study testing Educational programme in people with Secondary Headache Disorders and Medication-overuse Headache, run by Esbjerg Hospital - University Hospital of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondary Headache Disorders, Medication-overuse Headache
- What is being tested?
- Educational programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment
- Mental health disorders
About this study
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.
Read the 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.
- Being tested
- Educational programme
- Keywords
- Medication-overuse Headache, Educational Programme, Personality Profiles
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational programme | Experimental | Group 1: Educational programme + standard treatment Receives: Behavioral: Educational programme |
| Standard treatment | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency measured by self-reported headache diary on number of days with headache previous month
Measured: baseline-36 weeks follow-up
Secondary outcomes (6)
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)
Measured: Baseline
Coping Strategies
CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
Measured: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Pain Intensity
VAS (0: No pain, 10: Pain as bad as it can be)
Measured: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Bothersomeness
VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
Measured: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Patient satisfaction
Questionnarire
Measured: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Medication intake
self reported intake (type, name of medication, dosis)
Measured: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start15 Oct 2015
- Primary completion1 Jul 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Schlosser Mose, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Louise S. Mose, MHS, Principal investigator, Hospital of South West Jutland, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768233
- Sponsor's protocol ID
- S-20140114
- Status last verified
- Jan 2023
- First submitted
- 9 May 2016
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31661579
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
- ClinicalTrials.gov ID
- NCT02768233
- Acronym / sponsor ID
- S-20140114
- Keywords
- Medication-overuse Headache, Educational Programme, Personality Profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational programme | Experimental | Behavioral: Educational programmeGroup 1: Educational programme + standard treatment |
| Standard treatment | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment
- Mental health disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programmeThe 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. | Behavioural | Educational programme |
Primary outcome
Headache frequency measured by self-reported headache diary on number of days with headache previous month
Time frame: baseline-36 weeks follow-up
6 secondary outcomes
NEO-FFI-3 personality test
Time frame: Baseline
Coping Strategies
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Pain Intensity
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Bothersomeness
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Patient satisfaction
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Medication intake
Time frame: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 31661579Mose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise S. Mose, MHS principal investigator
Hospital of South West Jutland, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Educational programme in people with Secondary Headache Disorders and Medication-overuse Headache, run by Esbjerg Hospital - University Hospital of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency measured by self-reported headache diary on number of days with headache previous month (time frame: baseline-36 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.