Clinical trial NCT01314768: Brief Intervention for Medication Overuse Headache
Official title: RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication-overuse Headache
Chronic Headache
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-03-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of medication days per month
timeFrame: 3 months
measure: Number of headache days per month
timeFrame: 3 months
Secondary outcomes:
measure: Proportion significantly improved
timeFrame: 3 month
measure: Headache medication days per month (diary reported)
timeFrame: 3 months
measure: Headache days/month (diary reported)
timeFrame: 3 months
measure: Average headache intensity (VAS)
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Self-reported health related costs
timeFrame: 3 months
measure: Long term follow up of same outcomes as above plus relapse rate
timeFrame: 12 months
measure: Headache index
timeFrame: 3 months
measure: Follow up of same outcomes as for 3 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Dept of general medicine, University of Oslo
Study officials:
affiliation: Akershus University Hospital and University of Oslo
name: Christofer Lundqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundqvist C, Gossop M, Russell MB, Straand J, Kristoffersen ES. Severity of Analgesic Dependence and Medication-overuse Headache. J Addict Med. 2019 Sep/Oct;13(5):346-353. doi: 10.1097/ADM.0000000000000504.
citation: Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Predictors of successful primary care detoxification treatment for medication-overuse headache. Acta Neurol Scand. 2017 Nov;136(5):486-494. doi: 10.1111/ane.12759. Epub 2017 Mar 28.
citation: Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.
citation: Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Disability, anxiety and depression in patients with medication-overuse headache in primary care - the BIMOH study. Eur J Neurol. 2016 Jan;23 Suppl 1:28-35. doi: 10.1111/ene.12850.
citation: Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.
citation: Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Study protocol: brief intervention for medication overuse headache--a double-blinded cluster randomised parallel controlled trial in primary care. BMC Neurol. 2012 Aug 10;12:70. doi: 10.1186/1471-2377-12-70.