Back to resultsShort Intervention for Medication Overuse Headache (MOH) - Pilot (SIMOHpilot)
Primary Purpose
Medication Overuse Headache
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Trained counselling
Sponsored by
About this trial
This is an interventional treatment trial for Medication Overuse Headache
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with medication overuse headache
Exclusion Criteria:
- Other complicating pain condition
Sites / Locations
- Department of General Practice and Community Medicine
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Trained counselling
Arm Description
Comparison of outcomes before intervention vs. 2 months after
Outcomes
Primary Outcome Measures
Qualitative comments of participants on acceptability and utility
Secondary Outcome Measures
Qualitative comments of participants on acceptability and utility.
Number of medication days per month
Full Information
NCT ID
NCT01078012
First Posted
March 1, 2010
Last Updated
December 29, 2015
Sponsor
University Hospital, Akershus
Collaborators
Department of General Practice and Community Medicine, Oslo, Head and Neck Research Group, Lørenskog
1. Study Identification
Unique Protocol Identification Number
NCT01078012
Brief Title
Short Intervention for Medication Overuse Headache (MOH) - Pilot
Acronym
SIMOHpilot
Official Title
Pilot Study of Short Intervention for Medication Overuse Headache in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Department of General Practice and Community Medicine, Oslo, Head and Neck Research Group, Lørenskog
4. Oversight
Data Monitoring Committee
No
5. 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".
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trained counselling
Arm Type
Active Comparator
Arm Description
Comparison of outcomes before intervention vs. 2 months after
Intervention Type
Behavioral
Intervention Name(s)
Trained counselling
Primary Outcome Measure Information:
Title
Qualitative comments of participants on acceptability and utility
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Qualitative comments of participants on acceptability and utility.
Time Frame
2 months
Title
Number of medication days per month
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with medication overuse headache
Exclusion Criteria:
Other complicating pain condition
Facility Information:
Facility Name
Department of General Practice and Community Medicine
City
Oslo
ZIP/Postal Code
0318
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
24646429
Citation
Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Feasibility of a brief intervention for medication-overuse headache in primary care--a pilot study. BMC Res Notes. 2014 Mar 20;7:165. doi: 10.1186/1756-0500-7-165.
Results Reference
derived
Learn more about this trial
Short Intervention for Medication Overuse Headache (MOH) - Pilot
We'll reach out to this number within 24 hrs