Headache DisordersNCT05111873
Effects of Multimodal Treatment of Headache in a Day Clinic Service
An observational study of Headache Disorders, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The observational study aims to investigate the effects of a multimodal treatment program for headache patients in a day clinic service. The setting provides one week of treatment including a combination of medical consultation, physiotherapy, psychological therapy, occupational therapy, progressive muscle relaxation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache Disorders
- What is being tested?
- multimodal treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2021to 30 May 2022
- 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: All patients seen in the neurological day clinic service will be screened for eligibility.
Who may be able to join
- diagnosis of a headache disorder
- written informed consent for collecting and analysing data and conducting a follow-up evaluation
Who cannot join
- premature interruption of the treatment
- repeated treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology
Greifswald, Mecklenburg-Vorpommern, 17475
Robert Fleischmann, MD, +49-3834 86-6855, robert.fleischmann@uni-greifswald.de
Robert Fleischmann, MD
About this study
Official title: Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study
The observational study aims to investigate the effects of a multimodal treatment program for headache patients in a day clinic service. The setting provides one week of treatment including a combination of medical consultation, physiotherapy, psychological therapy, occupational therapy, progressive muscle relaxation and disease specific education.
Outcome measures are the disease-specific impact on daily activities, general quality of life, psychological impact and headache frequency. Moreover, the study sought to identify parameters that best predict efficacy of the intervention. Therefore, standardized questionnaires are established in three points in time, to evaluate the pre- and post-treatment status.
Read the detailed description
duration of treatment: 5 days; first questionnaire (V0): minimal 4 weeks prior to the treatment appointment; second questionnaire (V1): on the first day of the treatment program; third questionnaire (V2 / Follow up): 3 month (+- 6 weeks) after finishing the treatment; data collection through patient self-report; Follow-up via mail
- Conditions
- Headache Disorders
- Being tested
- multimodal treatment
- Keywords
- multimodal treatment, quality of life, day clinic service
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal treatmentOther
combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| waiting-list control | Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention | |
| post-treatment group | Participants enquired after the treatment in the Neurological day clinic service Receives: Other: multimodal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score
questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary outcomes (5)
Change of Depression Anxiety and Stress Scale (DASS)
questionnaire, patient self-report, 21 questions, 7 questions per subscale (Depression, Anxiety and Stress), minimum value: 0 points, maximum value: 21 points per subscale, higher score = worse outcome
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Headache Impact Test (HIT6)
questionnaire, patient self-report, minimum value: 36 points, maximum value: 78 points, higher score = worse outcome
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Pain intensity
average pain intensity in the last month, scale 1 to 10, higher score = worse outcome
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Headache frequency
in days per month, referring to the last month, minimum value: 0 days/month, maximum value: 30 days/month
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Veterans RAND 12 Item Health Survey (VR-12) physical health score
questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10
Measured: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start15 Feb 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111873
- Sponsor's protocol ID
- BB004/21
- Status last verified
- Oct 2021
- First submitted
- 12 Jul 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study
- ClinicalTrials.gov ID
- NCT05111873
- Acronym / sponsor ID
- BB004/21
- Conditions
- Headache Disorders
- Keywords
- multimodal treatment, quality of life, day clinic service
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 8 Nov 2021 (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.
The observational study aims to investigate the effects of a multimodal treatment program for headache patients in a day clinic service. The setting provides one week of treatment including a combination of medical consultation, physiotherapy, psychological therapy, occupational therapy, progressive muscle relaxation and disease specific education.
Outcome measures are the disease-specific impact on daily activities, general quality of life, psychological impact and headache frequency. Moreover, the study sought to identify parameters that best predict efficacy of the intervention. Therefore, standardized questionnaires are established in three points in time, to evaluate the pre- and post-treatment status.
Detailed description
duration of treatment: 5 days; first questionnaire (V0): minimal 4 weeks prior to the treatment appointment; second questionnaire (V1): on the first day of the treatment program; third questionnaire (V2 / Follow up): 3 month (+- 6 weeks) after finishing the treatment; data collection through patient self-report; Follow-up via mail
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| waiting-list control | – | –Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention |
| post-treatment group | – | Other: multimodal treatmentParticipants enquired after the treatment in the Neurological day clinic service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen in the neurological day clinic service will be screened for eligibility.
Key inclusion criteria (2 listed)
- diagnosis of a headache disorder
- written informed consent for collecting and analysing data and conducting a follow-up evaluation
Key exclusion criteria (2 listed)
- premature interruption of the treatment
- repeated treatment
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 |
|---|---|---|
| multimodal treatmentcombination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation | Other | post-treatment group |
Primary outcome
Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
questionnaire, patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10
5 secondary outcomes
Change of Depression Anxiety and Stress Scale (DASS)
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Headache Impact Test (HIT6)
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Pain intensity
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Headache frequency
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Change of Veterans RAND 12 Item Health Survey (VR-12) physical health score
Time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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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.
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 Headache Disorders, run by University Medicine Greifswald 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Fleischmann, MD (+493834866778, robert.fleischmann@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score (time frame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment). 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 8 Nov 2021.