Brief Intervention for Medication Overuse Headache

Not Applicable

Completed

• Conditions: Chronic Headache; Medication-overuse Headache
• Interventions: Behavioral: Brief intervention; Other: Business as usual; Other: Screening and outcome evaluation only

• Registration Number: NCT01314768
• Lead Sponsor: University Hospital, Akershus

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Primary Completion: 2012-11
• Study Completion: 2013-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief intervention	Brief intervention	Behavioural brief intervention delivered by GP
Business as usual	Business as usual	Business as usual according to individual GP
Population control	Screening and outcome evaluation only	Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Chronic headache control	Screening and outcome evaluation only	Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point

Primary Outcome Measures

Name	Time	Method
Number of medication days per month	3 months
Number of headache days per month	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dept of general medicine, University of Oslo; 🇳🇴 Oslo, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Norway