Medication-overuse Headache, Chronic Headache
Conditions
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
Structured behavioural Brief intervention given by trained GPs
GPs to treat patient as they have until now based on best established practice
No additional intervention
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of medication days per month | 3 months |
| Number of headache days per month | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache days/month (diary reported) | 3 months | — |
| Average headache intensity (VAS) | 3 months | — |
| Quality of life | 3 months | — |
| Proportion significantly improved | 3 month | proportion improved \>50% and \>25% in terms of no headache days/month |
| 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. |
| Self-reported health related costs | 3 months | — |
| Headache medication days per month (diary reported) | 3 months | — |
Countries
Norway