Integrated Care for Migraine and Chronic Tension-type Headaches

NCT03503734 | Completed

• 1 other identifier: 11-4749
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headache

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  Headache days/month

  Treatment end, an average of 5 months

Secondary Outcomes (17)

• Headache frequency

  6 months after treatment end

• Pain intensity

  Treatment end, an average of 5 months

• Pain intensity

  6 months after treatment end

• Pain bothersomeness

  Treatment end, an average of 5 months

• Pain bothersomeness

  6 months after treatment end

Study Arms (1)

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

Interventions

Integrated headache care BEHAVIORAL

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.

Integrated headache care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 20, 2018
• Study Start: August 18, 2011
• Primary Completion: July 30, 2013
• Study Completion: January 30, 2014
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)