Integrated Care for Migraine and Chronic Tension-type Headaches (IV)

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 Overview

• Status: Completed
• Conditions: Chronic Headache
• Intervention / Treatment: Behavioral: Integrated headache care

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 Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients insured with Barmer GEK or Techniker Krankenkasse, large German statutory health insurances, and diagnosed with migraine and/or tension-type headaches were eligible for integrated care. All patients, who were over 18 years old with headache at least five days per month for at least 6 months and current intake of a) at least 10 triptans per month or b) analgesic drugs that can themselves elicit headache were suited to be involved in the observational study. Patients were referred by specialists or general practitioners to the Department of Internal and Integrative Medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache frequency	Headache days/month	Treatment end, an average of 5 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2011
• Primary Completion (ACTUAL): July 30, 2013
• Study Completion (ACTUAL): January 30, 2014

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (ACTUAL): April 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache; Tension-Type Headache; Headache Disorders
• Other Study ID Numbers: 11-4749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No