Effects of Multimodal Treatment of Headache in a Day Clinic Service

NCT ID: NCT05111873

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-05-30

Brief Summary

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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

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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

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Headache Disorders

Keywords

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multimodal treatment quality of life day clinic service

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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waiting-list control

Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention

No interventions assigned to this group

post-treatment group

Participants enquired after the treatment in the Neurological day clinic service

multimodal treatment

Intervention Type OTHER

combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation

Interventions

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multimodal treatment

combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of a headache disorder
* written informed consent for collecting and analysing data and conducting a follow-up evaluation

Exclusion Criteria

* premature interruption of the treatment
* repeated treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Robert Fleischmann, MD

Role: CONTACT

Phone: +493834866778

Email: [email protected]

Facility Contacts

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Robert Fleischmann, MD

Role: primary

Other Identifiers

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BB004/21

Identifier Type: -

Identifier Source: org_study_id