Medication-overuse HeadacheBIMOHNCT01314768
Brief Intervention for Medication Overuse Headache
A study testing Brief intervention, Business as usual and Screening and outcome evaluation only in people with Medication-overuse Headache and Chronic Headache, run by University Hospital, Akershus at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Medication-overuse Headache, Chronic Headache
- What is being tested?
- Brief intervention, Business as usual and Screening and outcome evaluation only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 2 sitesNorway
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Other complicating pain with medication treatment
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog
Dept of general medicine, University of Oslo
Oslo
About this study
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.
Read more
Main outcomes are:
- number of medication days per month
- number of headache days per month
- headache index
Read the 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).
- Conditions
- Medication-overuse Headache, Chronic Headache
- Being tested
- Brief intervention, Business as usual, Screening and outcome evaluation only
- Medical subject headings
- Headache Disorders, Secondary, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
Structured behavioural Brief intervention given by trained GPs
Business as usualOther
GPs to treat patient as they have until now based on best established practice
Screening and outcome evaluation onlyOther
No additional intervention
Screening and outcome evaluation onlyOther
No additional intervention
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention | Active comparator | Behavioural brief intervention delivered by GP Receives: Behavioral: Brief intervention |
| Business as usual | Placebo comparator | Business as usual according to individual GP Receives: Other: Business as usual |
| Chronic headache control | Other | Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point Receives: Other: Screening and outcome evaluation only |
| Population control | Other | Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point Receives: Other: Screening and outcome evaluation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medication days per month
Measured: 3 months
Number of headache days per month
Measured: 3 months
Secondary outcomes (9)
Proportion significantly improved
proportion improved >50% and >25% in terms of no headache days/month
Measured: 3 month
Headache medication days per month (diary reported)
Measured: 3 months
Headache days/month (diary reported)
Measured: 3 months
Average headache intensity (VAS)
Measured: 3 months
Quality of life
Measured: 3 months
Self-reported health related costs
Measured: 3 months
Long term follow up of same outcomes as above plus relapse rate
Measured: 12 months
Headache index
Headache intensity x frequency x duration
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Medication-overuse HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Christofer Lundqvist, University Hospital, Akershus
- Investigators
- Christofer Lundqvist, MD, PhD, Principal investigator, Akershus University Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314768
- Sponsor's protocol ID
- BIMOH
- Acronym
- BIMOH
- Status last verified
- Dec 2015
- First submitted
- 14 Mar 2011
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30724760Kristoffersen 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.
PubMed 28369734Kristoffersen 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.
PubMed 26645391Kristoffersen 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.
PubMed 26563095Kristoffersen 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.
PubMed 25112307Kristoffersen 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.
PubMed 22883540
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
- ClinicalTrials.gov ID
- NCT01314768
- Acronym / sponsor ID
- BIMOH / BIMOH
- Conditions
- Medication-overuse Headache, Chronic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brief intervention | Active comparator | Behavioral: Brief interventionBehavioural brief intervention delivered by GP |
| Business as usual | Placebo comparator | Other: Business as usualBusiness as usual according to individual GP |
| Chronic headache control | Other | Other: Screening and outcome evaluation onlyScreening and outcome control only. Non-intervention Control, screened and followed-up at final time point |
| Population control | Other | Other: Screening and outcome evaluation onlyScreening and outcome control only. Non-intervention Control, screened and followed-up at final time point |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Other complicating pain with medication treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionStructured behavioural Brief intervention given by trained GPs | Behavioural | Brief intervention |
| Business as usualGPs to treat patient as they have until now based on best established practice | Other | Business as usual |
| Screening and outcome evaluation onlyNo additional intervention | Other | Chronic headache control |
| Screening and outcome evaluation onlyNo additional intervention | Other | Population control |
Primary outcome
Number of medication days per month
Time frame: 3 months
Number of headache days per month
Time frame: 3 months
9 secondary outcomes
Proportion significantly improved
Time frame: 3 month
Headache medication days per month (diary reported)
Time frame: 3 months
Headache days/month (diary reported)
Time frame: 3 months
Average headache intensity (VAS)
Time frame: 3 months
Quality of life
Time frame: 3 months
Self-reported health related costs
Time frame: 3 months
Long term follow up of same outcomes as above plus relapse rate
Time frame: 12 months
Headache index
Time frame: 3 months
Follow up of same outcomes as for 3 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Derived from this study: PubMed 30724760Lundqvist 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.
- Derived from this study: PubMed 28369734Kristoffersen 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.
- Derived from this study: PubMed 26645391Kristoffersen 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.
- Derived from this study: PubMed 26563095Kristoffersen 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.
- Derived from this study: PubMed 25112307Kristoffersen 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.
- Derived from this study: PubMed 22883540Kristoffersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christofer Lundqvist, MD, PhD principal investigator
Akershus University Hospital and University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention, Business as usual and Screening and outcome evaluation only in people with Medication-overuse Headache and Chronic Headache, run by University Hospital, Akershus at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of medication days per month (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314768, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.