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

M

Modulex

Status

Completed

Conditions

Medication-overuse Headache
Secondary Headache Disorders

Treatments

Behavioral: Educational programme

Study type

Interventional

Funder types

Other

Identifiers

NCT02768233
S-20140114

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

Educational programme
Experimental group
Description:
Group 1: Educational programme + standard treatment
Treatment:
Behavioral: Educational programme
Standard treatment
No Intervention group
Description:
Standard treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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