Skip to main content
OpenTrials
Completed

NCT Number: NCT05278325

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Telephone Intervention

Other

Two planned phone call between clinical controls

Primary outcomes

  1. Change in preventive headache medication

    Time frame: From baseline to six months

    Difference in number of patients with change in preventive headache medication in the two groups

  2. Change in acute headache medication

    Time frame: From baseline to six months

    Difference in number of patients with change in acute headache medication in the two groups

Secondary outcomes

  1. Change in headache frequency

    Time frame: From baseline to six months

    Difference in change of headache days per month between the two groups

  2. Change in migraine frequency

    Time frame: From baseline to six months

    Difference in change of migraine days per month between the two groups

  3. Change in Headache Under response to Treatment (HURT-8) score

    Time frame: From baseline to six months

    Difference in change in HURT-8 scale between the two groups

  4. Change in Insomnia Severity Index (ISI) score

    Time frame: From baseline to six months

    Difference in change in ISI score between the two groups

  5. Change in Hospitality Anxiety Depression Scale (HADS) score

    Time frame: From baseline to six months

    Difference in change in HADS between the two groups

  6. Change in patient satisfaction score

    Time frame: At six months

    Difference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Acronym: TeII

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2022
Registry last updated
Mar 14, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.