Integrated Care for Migraine and Chronic Tension-type Headaches

Chronic Headache Clinical Trial

— IV  

Official title:

Integrated Care for Migraine and Chronic Tension-type Headaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503734
• Other study ID #: 11-4749
• Status: Completed
• First received: April 11, 2018
• Last updated: April 19, 2018
• Start date: August 18, 2011
• Est. completion date: January 30, 2014

Study information

• Verified date: April 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 30, 2014
• Est. primary completion date: July 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders
• Tension-Type Headache

Intervention

Behavioral:
• Integrated headache care
The treatment can be realized on an inpatient, outpatient and/or day care basis, according to the severity level of illness and comorbidities. The inpatient treatment takes place at the Department of Internal and Integrative Medicine. The stay is slated for 14 days. Day care can follow the inpatient stay or can be applied as sole therapy. As part of the standard care provided at the Department for Internal and Integrative Medicine, it occurs at a semi-residential clinic for 6 hours once a week over a total of 10 weeks. The outpatient treatment is delivered in the Department's outpatient ward. It consists of acupuncture, cupping, hydrotherapy and massages as well as nutritional counseling. The patients can additionally be offered one-to-one mind-body-medicine interventions.

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency	Headache days/month	Treatment end, an average of 5 months
Secondary	Headache frequency	Headache days/month	6 months after treatment end
Secondary	Pain intensity	100mm visual analog scale	Treatment end, an average of 5 months
Secondary	Pain intensity	100mm visual analog scale	6 months after treatment end
Secondary	Pain bothersomeness	100mm visual analog scale	Treatment end, an average of 5 months
Secondary	Pain bothersomeness	100mm visual analog scale	6 months after treatment end
Secondary	Pain perception	Pain Perception Scale	Treatment end, an average of 5 months
Secondary	Pain perception	Pain Perception Scale	6 months after treatment end
Secondary	Quality of life	SF-12	Treatment end, an average of 5 months
Secondary	Quality of life	SF-12	6 months after treatment end
Secondary	Headache Disability	Headache Disability Inventory (HDI)	Treatment end, an average of 5 months
Secondary	Headache Disability	Headache Disability Inventory (HDI)	6 months after treatment end
Secondary	Anxiety/Depression Scale	Hospital Anxiety and Depression Scale (HADS)	Treatment end, an average of 5 months
Secondary	Anxiety/Depression Scale	Hospital Anxiety and Depression Scale (HADS)	6 months after treatment end
Secondary	Function	Patient-specific Functional Scale (PSFS)	Treatment end, an average of 5 months
Secondary	Function	Patient-specific Functional Scale (PSFS)	6 months after treatment end
Secondary	Self-Efficacy	Pain Self-Efficacy Questionnaire (FESS)	Treatment end, an average of 5 months
Secondary	Self-Efficacy	Pain Self-Efficacy Questionnaire (FESS)	6 months after treatment end