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NCT Number: NCT01314768

Brief Intervention for Medication Overuse Headache

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

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Key information

Conditions

Medication-overuse Headache Brain Diseases Central Nervous System Diseases Chronic Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Lørenskog, Norway

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention

Behavioral

Structured behavioural Brief intervention given by trained GPs

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

Primary outcomes

  1. Number of medication days per month

    Time frame: 3 months

  2. Number of headache days per month

    Time frame: 3 months

Secondary outcomes

  1. Proportion significantly improved

    Time frame: 3 month

    proportion improved >50% and >25% in terms of no headache days/month

  2. Headache medication days per month (diary reported)

    Time frame: 3 months

  3. Headache days/month (diary reported)

    Time frame: 3 months

  4. Average headache intensity (VAS)

    Time frame: 3 months

  5. Quality of life

    Time frame: 3 months

  6. Self-reported health related costs

    Time frame: 3 months

  7. Long term follow up of same outcomes as above plus relapse rate

    Time frame: 12 months

  8. Headache index

    Time frame: 3 months

    Headache intensity x frequency x duration

  9. Follow up of same outcomes as for 3 months

    Time frame: 6 months

    Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • University of Oslo

Registry information

Official study title

RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

Acronym: BIMOH

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 15, 2011
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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