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

This study has been completed.
Sponsor:
Collaborators:
Department of General Practice and Community Medicine, Oslo
Head and Neck Research Group, Lørenskog
Information provided by (Responsible Party):
Christofer Lundqvist, Akershus University College
ClinicalTrials.gov Identifier:
NCT01078012
First received: March 1, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Medication Overuse Headache
 Behavioral: Trained counselling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Short Intervention for Medication Overuse Headache in General Practice

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Qualitative comments of participants on acceptability and utility [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative comments of participants on acceptability and utility. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Number of medication days per month [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trained counselling
Comparison of outcomes before intervention vs. 2 months after
 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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with medication overuse headache

Exclusion Criteria:

  • Other complicating pain condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christofer Lundqvist, Principal Investigator, Akershus University College
ClinicalTrials.gov Identifier: NCT01078012     History of Changes
Other Study ID Numbers: SIMOH pilot
Study First Received: March 1, 2010
Last Updated: January 9, 2013
Health Authority: Norway: Norwegian Directory of Health
Norway: Data Protection Authority

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013