Short Intervention for Medication Overuse Headache (MOH) - Pilot

Medication Overuse Headache Clinical Trial

— SIMOHpilot  

Official title:

Pilot Study of Short Intervention for Medication Overuse Headache in General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078012
• Other study ID #: SIMOH pilot
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: December 29, 2015
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Directory of HealthNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate whether training of GPs in the detection and treatment of medication overuse headache leads to improved care for these patients as compared to "business as usual".

Description:

The present pilot study focuses on testing the logistics and the methodology of short intervention on a pilot group of GPs and their patients.

Due to low recruitment and the pilot study focus on logistics and methodology, the study was changed to not include a control (business as usual) arm. The outcomes were evaluated as "before - after" data and qualitative comments on acceptability and utility of the method. Primary outcomes were changed to be the acceptability and utility (previously listed as secondary outcomes) while secondary outcomes were headache days and medication days (previously listed as primary).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Diagnosed with medication overuse headache

Exclusion Criteria:

• Other complicating pain condition

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

Behavioral:
• Trained counselling

Locations

Country	Name	City	State
Norway	Department of General Practice and Community Medicine	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	Department of General Practice and Community Medicine, Oslo, Head and Neck Research Group, Lørenskog

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative comments of participants on acceptability and utility		2 months	No
Secondary	Qualitative comments of participants on acceptability and utility.		2 months	No
Secondary	Number of medication days per month		2 months	No