Integrated Care for Migraine and Chronic Tension-type Headaches

Completed

• Conditions: Chronic Headache

• Registration Number: NCT03503734
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Detailed Description

Chronic headache is among the most common neurological disorders with major physical, psychological, social and economic impact. The aim of this prospective observational study isto investigate the effects of an interdisciplinary multimodal integrated care program in patients with chronic migraine and/or tension-type headache.

158 patients with chronic migraine or tensions-type headache at least five days per month for at least 6 months and current intake of triptans (migraine) or analgesic drugs (tension-type headache) are eligible. Patients undergo inpatient, outpatient and/or semi-stationary treatment including conventional headache diagnostics and therapy as well as traditional Chinese medicine, European naturopathy, and mind-body-medicine approaches. Headache frequency is defined as the primary outcome; secondary outcomes include pain (visual analog scale, Pain Perception Scale), triptans and analgesics use (headache diary), health-related quality of life (SF-36), function (Headache Disability Inventory, Patient-specific Functional Scale), depression and anxiety (Hospital Anxiety and Depression Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Outcomes are assessed at treatment start, treatment end and 6 months after treatment end.

Study Timeline

• Study Start: 2011-08-18
• Primary Completion: 2013-07-30
• Study Completion: 2014-01-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

headache at least five days per month for at least 6 months current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Headache frequency	Treatment end, an average of 5 months	Headache days/month

Secondary Outcome Measures

Name	Time	Method
Pain perception	6 months after treatment end	Pain Perception Scale
Function	6 months after treatment end	Patient-specific Functional Scale (PSFS)
Pain bothersomeness	6 months after treatment end	100mm visual analog scale
Headache frequency	6 months after treatment end	Headache days/month
Self-Efficacy	6 months after treatment end	Pain Self-Efficacy Questionnaire (FESS)
Pain intensity	6 months after treatment end	100mm visual analog scale
Quality of life	6 months after treatment end	SF-12
Headache Disability	6 months after treatment end	Headache Disability Inventory (HDI)
Anxiety/Depression Scale	6 months after treatment end	Hospital Anxiety and Depression Scale (HADS)

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; 🇩🇪 Essen, NRW, Germany