RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Number of medication days per month
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of medication days per month
Time Frame: 3 months
Number of headache days per month
Time Frame: 3 months
Secondary Outcomes
- Quality of life(3 months)
- Proportion significantly improved(3 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)
- Follow up of same outcomes as for 3 months(6 months)
Investigators
Christofer Lundqvist
Principal investigator/Project leader
University Hospital, Akershus