Brief Intervention for Medication Overuse Headache

Chronic Headache Clinical Trial

— BIMOH  

Official title:

RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314768
• Other study ID #: BIMOH
• Status: Completed
• Phase: N/A
• First received: March 14, 2011
• Last updated: December 29, 2015
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The investigators will perform a cluster randomised controlled study of Brief intervention (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to perform a structured brief intervention after identifying patients with probable MOH using the severity of dependence scale. The control arm will include patients of GPs who have not been trained in BI. Patients will be recruited by prior short postal screening of patients listed on the GPs patient lists.

The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache as compared to no BI.

Main outcomes are:

• number of medication days per month

• number of headache days per month

• headache index

Description:

123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention Control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8 in intervention arm and placebo arm respectively, 4 and 2 in chronic headache Control and population Control respectively)

1 case was lost to follow up in each of the 4 Groups prior to first assessment. Thus 60 cases remained in intervention/placebo Control arms (24 in intervention and 36 in placebo Control) and 40 in non intervention Control arms (15 chronic headache Controls, 25 population Controls).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 years of age

• Screening positive for possible chronic headache (> 10 headache days per month) (not for population control arm)

• Screening positive for possible medication-overuse (> 15 medication days per month) (not for chronic headache control arm)

Exclusion Criteria:

• Other complicating pain with medication treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders, Secondary
• Medication-overuse Headache

Intervention

Behavioral:
• Brief intervention
Structured behavioural Brief intervention given by trained GPs

Other:
• Business as usual
GPs to treat patient as they have until now based on best established practice
• Screening and outcome evaluation only
No additional intervention
• Screening and outcome evaluation only
No additional intervention

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Dept of general medicine, University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of medication days per month		3 months	No
Primary	Number of headache days per month		3 months	No
Secondary	Proportion significantly improved	proportion improved >50% and >25% in terms of no headache days/month	3 month	No
Secondary	Headache medication days per month (diary reported)		3 months	No
Secondary	Headache days/month (diary reported)		3 months	No
Secondary	Average headache intensity (VAS)		3 months	No
Secondary	Quality of life		3 months	No
Secondary	Self-reported health related costs		3 months	No
Secondary	Long term follow up of same outcomes as above plus relapse rate		12 months	No
Secondary	Headache index	Headache intensity x frequency x duration	3 months	No
Secondary	Follow up of same outcomes as for 3 months	Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.	6 months	No