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

Medication-overuse Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768233
• Other study ID #: S-20140114
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Secondary
• Medication-overuse Headache
• Secondary Headache Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of South West Jutland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency measured by self-reported headache diary on number of days with headache previous month		baseline-36 weeks follow-up
Secondary	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)	Baseline
Secondary	Coping Strategies	CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)	Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Secondary	Pain Intensity	VAS (0: No pain, 10: Pain as bad as it can be)	Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Secondary	Bothersomeness	VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)	Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Secondary	Patient satisfaction	Questionnarire	Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Secondary	Medication intake	self reported intake (type, name of medication, dosis)	baseline, Post intervention (16 weeks) and Follow-up (36 weeks)