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

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

Sponsors

Lead Sponsor: Hospital of South West Denmark

Source Hospital of South West Denmark
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.

Overall Status Completed
Start Date 2015-10-15
Completion Date 2019-01-01
Primary Completion Date 2018-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Headache frequency measured by self-reported headache diary on number of days with headache previous month baseline-36 weeks follow-up
Secondary Outcome
Measure Time Frame
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)
Medication intake baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
Enrollment 98
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Educational programme

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.

Arm Group Label: Educational programme

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Louise S. Mose, MHS Principal Investigator Hospital of South West Jutland, Denmark
Verification Date

2020-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital of South West Denmark

Investigator Full Name: Louise Schlosser Mose

Investigator Title: PhD student

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Educational programme

Type: Experimental

Description: Group 1: Educational programme + standard treatment

Label: Standard treatment

Type: No Intervention

Description: Standard treatment

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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