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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief intervention | Active Comparator | Behavioural brief intervention delivered by GP |
|
| Business as usual | Placebo Comparator | Business as usual according to individual GP |
|
| Chronic headache control | Other | Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point |
|
| Population control | Other | Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief intervention | Behavioral | Structured behavioural Brief intervention given by trained GPs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of medication days per month | 3 months | |
| Number of headache days per month | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion significantly improved | proportion improved >50% and >25% in terms of no headache days/month | 3 month |
| Headache medication days per month (diary reported) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christofer Lundqvist, MD, PhD | Akershus University Hospital and University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Norway | ||||
| Dept of general medicine, University of Oslo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30724760 | Derived | 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. | |
| 28369734 | Derived | 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. |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| D003132 | Commerce |
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013676 | Technology, Industry, and Agriculture |
| D019937 | Diagnostic Techniques and Procedures |
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| Business as usual | Other | GPs to treat patient as they have until now based on best established practice |
|
| Screening and outcome evaluation only | Other | No additional intervention |
|
| Screening and outcome evaluation only | Other | No additional intervention |
|
| Headache days/month (diary reported) | 3 months |
| Average headache intensity (VAS) | 3 months |
| Quality of life | 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 | Headache intensity x frequency x duration | 3 months |
| Follow up of same outcomes as for 3 months | Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months. | 6 months |
| Oslo |
| Norway |
| 26645391 | Derived | 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. |
| 26563095 | Derived | 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. |
| 25112307 | Derived | 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. |
| 22883540 | Derived | 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. |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |