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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Hospital of South West Denmark

Current Primary Outcome: Headache frequency measured by self-reported headache diary on number of days with headache previous month [ Time Frame: One month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NEO-FFI-3 personality test [ Time Frame: Baseline ]
    self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)
  • Coping Strategies [ Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks) ]
    CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
  • Pain Intensity [ Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks) ]
    VAS (0: No pain, 10: Pain as bad as it can be)
  • Bothersomeness [ Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks) ]
    VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
  • Patient satisfaction [ Time Frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks) ]
    Questionnarire
  • Medication intake [ Time Frame: One month ]
    self reported intake (type, name of medication, dosis)


Original Secondary Outcome: Same as current

Information By: Hospital of South West Denmark

Dates:
Date Received: May 9, 2016
Date Started: October 2015
Date Completion: March 2018
Last Updated: February 24, 2017
Last Verified: February 2017