Chronic HeadacheIVNCT03503734
Integrated Care for Migraine and Chronic Tension-type Headaches
An observational study of Chronic Headache, run by Universität Duisburg-Essen at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Headache
- What is being tested?
- Integrated headache care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2011to 30 Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, North Rhine-Westphalia, 45276
About this study
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.
Read the 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.
- Conditions
- Chronic Headache
- Being tested
- Integrated headache care
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated headache careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated headache care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
Headache days/month
Measured: Treatment end, an average of 5 months
Secondary outcomes (17)
Headache frequency
Headache days/month
Measured: 6 months after treatment end
Pain intensity
100mm visual analog scale
Measured: Treatment end, an average of 5 months
Pain intensity
100mm visual analog scale
Measured: 6 months after treatment end
Pain bothersomeness
100mm visual analog scale
Measured: Treatment end, an average of 5 months
Pain bothersomeness
100mm visual analog scale
Measured: 6 months after treatment end
Pain perception
Pain Perception Scale
Measured: Treatment end, an average of 5 months
Pain perception
Pain Perception Scale
Measured: 6 months after treatment end
Quality of life
SF-12
Measured: Treatment end, an average of 5 months
Quality of life
SF-12
Measured: 6 months after treatment end
Headache Disability
Headache Disability Inventory (HDI)
Measured: Treatment end, an average of 5 months
Headache Disability
Headache Disability Inventory (HDI)
Measured: 6 months after treatment end
Anxiety/Depression Scale
Hospital Anxiety and Depression Scale (HADS)
Measured: Treatment end, an average of 5 months
Anxiety/Depression Scale
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months after treatment end
Function
Patient-specific Functional Scale (PSFS)
Measured: Treatment end, an average of 5 months
Function
Patient-specific Functional Scale (PSFS)
Measured: 6 months after treatment end
Self-Efficacy
Pain Self-Efficacy Questionnaire (FESS)
Measured: Treatment end, an average of 5 months
Self-Efficacy
Pain Self-Efficacy Questionnaire (FESS)
Measured: 6 months after treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start18 Aug 2011
- Primary completion30 Jul 2013
- Study completion30 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503734
- Sponsor's protocol ID
- 11-4749
- Acronym
- IV
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care for Migraine and Chronic Tension-type Headaches
- ClinicalTrials.gov ID
- NCT03503734
- Acronym / sponsor ID
- IV / 11-4749
- Conditions
- Chronic Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 18 Aug 2011 (actual)
- Primary completion
- 30 Jul 2013 (actual)
- Study completion
- 30 Jan 2014 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated headache care | – | Behavioral: Integrated headache careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated headache careThe 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. | Behavioural | Integrated headache care |
Primary outcome
Headache frequency
Time frame: Treatment end, an average of 5 months
Headache days/month
17 secondary outcomes
Headache frequency
Time frame: 6 months after treatment end
Pain intensity
Time frame: Treatment end, an average of 5 months
Pain intensity
Time frame: 6 months after treatment end
Pain bothersomeness
Time frame: Treatment end, an average of 5 months
Pain bothersomeness
Time frame: 6 months after treatment end
Pain perception
Time frame: Treatment end, an average of 5 months
Pain perception
Time frame: 6 months after treatment end
Quality of life
Time frame: Treatment end, an average of 5 months
Quality of life
Time frame: 6 months after treatment end
Headache Disability
Time frame: Treatment end, an average of 5 months
Headache Disability
Time frame: 6 months after treatment end
Anxiety/Depression Scale
Time frame: Treatment end, an average of 5 months
Anxiety/Depression Scale
Time frame: 6 months after treatment end
Function
Time frame: Treatment end, an average of 5 months
Function
Time frame: 6 months after treatment end
Self-Efficacy
Time frame: Treatment end, an average of 5 months
Self-Efficacy
Time frame: 6 months after treatment end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Headache, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: Treatment end, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.