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Improved Treatment Course for Patients With Migraine and Tension-type Headache

Improved Treatment Course for Patients With Migraine and Tension-type Headache

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05278325
Acronym
TeII
Enrollment
187
Registered
2022-03-14
Start date
2020-05-01
Completion date
2021-10-05
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, Tension-Type Headache

Brief summary

The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center. All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment. Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program. All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.

Interventions

Two planned phone call between clinical controls

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Migraine and/or tension-type headache

Exclusion criteria

* Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia. * Included in clinical trials at the DHC.

Design outcomes

Primary

MeasureTime frameDescription
Change in preventive headache medicationFrom baseline to six monthsDifference in number of patients with change in preventive headache medication in the two groups
Change in acute headache medicationFrom baseline to six monthsDifference in number of patients with change in acute headache medication in the two groups

Secondary

MeasureTime frameDescription
Change in Headache Under response to Treatment (HURT-8) scoreFrom baseline to six monthsDifference in change in HURT-8 scale between the two groups
Change in Insomnia Severity Index (ISI) scoreFrom baseline to six monthsDifference in change in ISI score between the two groups
Change in headache frequencyFrom baseline to six monthsDifference in change of headache days per month between the two groups
Change in patient satisfaction scoreAt six monthsDifference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups
Change in Hospitality Anxiety Depression Scale (HADS) scoreFrom baseline to six monthsDifference in change in HADS between the two groups
Change in migraine frequencyFrom baseline to six monthsDifference in change of migraine days per month between the two groups

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026