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Clinical Trials/NCT03503734
NCT03503734
Completed
Not Applicable

Integrated Care for Migraine and Chronic Tension-type Headaches

Universität Duisburg-Essen1 site in 1 country158 target enrollmentAugust 18, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Headache
Sponsor
Universität Duisburg-Essen
Enrollment
158
Locations
1
Primary Endpoint
Headache frequency
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2011
End Date
January 30, 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Holger Cramer

Research Director

Universität Duisburg-Essen

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Headache frequency

Time Frame: Treatment end, an average of 5 months

Headache days/month

Secondary Outcomes

  • Pain perception(6 months after treatment end)
  • Function(6 months after treatment end)
  • Pain bothersomeness(6 months after treatment end)
  • Headache frequency(6 months after treatment end)
  • Self-Efficacy(6 months after treatment end)
  • Pain intensity(6 months after treatment end)
  • Quality of life(6 months after treatment end)
  • Headache Disability(6 months after treatment end)
  • Anxiety/Depression Scale(6 months after treatment end)

Study Sites (1)

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