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Brief Intervention for Medication Overuse Headache

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01314768
Acronym
BIMOH
Enrollment
123
Registered
2011-03-15
Start date
2011-03-31
Completion date
2013-12-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication-overuse Headache, Chronic Headache

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).

Interventions

BEHAVIORALBrief intervention

Structured behavioural Brief intervention given by trained GPs

GPs to treat patient as they have until now based on best established practice

OTHERScreening and outcome evaluation only

No additional intervention

Sponsors

University of Oslo
CollaboratorOTHER
University Hospital, Akershus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of medication days per month3 months
Number of headache days per month3 months

Secondary

MeasureTime frameDescription
Headache days/month (diary reported)3 months
Average headache intensity (VAS)3 months
Quality of life3 months
Proportion significantly improved3 monthproportion improved \>50% and \>25% in terms of no headache days/month
Long term follow up of same outcomes as above plus relapse rate12 months
Headache index3 monthsHeadache intensity x frequency x duration
Follow up of same outcomes as for 3 months6 monthsAdded extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.
Self-reported health related costs3 months
Headache medication days per month (diary reported)3 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026