Chronic Headache Clinical Trial
Official title:
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
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
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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