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Short Intervention for Medication Overuse Headache (MOH) - Pilot (SIMOHpilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01078012
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : December 30, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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".

Condition or disease Intervention/treatment
Medication Overuse Headache Behavioral: Trained counselling

Detailed 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).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Short Intervention for Medication Overuse Headache in General Practice
Study Start Date : March 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Trained counselling
Comparison of outcomes before intervention vs. 2 months after
Behavioral: Trained counselling


Outcome Measures

Primary Outcome Measures :
  1. Qualitative comments of participants on acceptability and utility [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Qualitative comments of participants on acceptability and utility. [ Time Frame: 2 months ]
  2. Number of medication days per month [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with medication overuse headache

Exclusion Criteria:

  • Other complicating pain condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078012


Locations
Norway
Department of General Practice and Community Medicine
Oslo, Norway, 0318
Sponsors and Collaborators
University Hospital, Akershus
Department of General Practice and Community Medicine, Oslo
Head and Neck Research Group, Lørenskog
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christofer Lundqvist, Principal Investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01078012     History of Changes
Other Study ID Numbers: SIMOH pilot
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Headache
Headache Disorders, Secondary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases