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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01314768
Other study ID # BIMOH
Secondary ID
Status Completed
Phase N/A
First received March 14, 2011
Last updated December 29, 2015
Start date March 2011
Est. completion date December 2013

Study information

Verified date December 2015
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of HealthNorway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical 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. 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date December 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

Behavioral:
Brief intervention
Structured behavioural Brief intervention given by trained GPs
Other:
Business as usual
GPs to treat patient as they have until now based on best established practice
Screening and outcome evaluation only
No additional intervention
Screening and outcome evaluation only
No additional intervention

Locations

Country Name City State
Norway Akershus University Hospital Lørenskog
Norway Dept of general medicine, University of Oslo Oslo

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Akershus University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of medication days per month 3 months No
Primary Number of headache days per month 3 months No
Secondary Proportion significantly improved proportion improved >50% and >25% in terms of no headache days/month 3 month No
Secondary Headache medication days per month (diary reported) 3 months No
Secondary Headache days/month (diary reported) 3 months No
Secondary Average headache intensity (VAS) 3 months No
Secondary Quality of life 3 months No
Secondary Self-reported health related costs 3 months No
Secondary Long term follow up of same outcomes as above plus relapse rate 12 months No
Secondary Headache index Headache intensity x frequency x duration 3 months No
Secondary 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 No
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