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

Not Applicable

Completed

• Conditions: Migraine; Tension-Type Headache
• Interventions: Other: Telephone intervention

• Registration Number: NCT05278325
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-05
• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone Intervention	Telephone intervention	Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment

Primary Outcome Measures

Name	Time	Method
Change in acute headache medication	From baseline to six months	Difference in number of patients with change in acute headache medication in the two groups
Change in preventive headache medication	From baseline to six months	Difference in number of patients with change in preventive headache medication in the two groups

Secondary Outcome Measures

Name	Time	Method
Change in migraine frequency	From baseline to six months	Difference in change of migraine days per month between the two groups
Change in Headache Under response to Treatment (HURT-8) score	From baseline to six months	Difference in change in HURT-8 scale between the two groups
Change in Insomnia Severity Index (ISI) score	From baseline to six months	Difference in change in ISI score between the two groups
Change in Hospitality Anxiety Depression Scale (HADS) score	From baseline to six months	Difference in change in HADS between the two groups
Change in headache frequency	From baseline to six months	Difference in change of headache days per month between the two groups
Change in patient satisfaction score	At six months	Difference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark