Clinical trial NCT05111873: Effects of Multimodal Treatment of Headache in a Day Clinic Service
Official title: Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache Disorders
Keywords: multimodal treatment
quality of life
day clinic service
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients seen in the neurological day clinic service will be screened for eligibility.

Brief 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 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

Eligibility criteria: 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

Primary outcomes:
measure: Change of Veterans RAND 12 Item Health Survey (VR-12) mental health score
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary outcomes:
measure: Change of Depression Anxiety and Stress Scale (DASS)
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
measure: Change of Headache Impact Test (HIT6)
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
measure: Change of Pain intensity
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
measure: Change of Headache frequency
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
measure: Change of Veterans RAND 12 Item Health Survey (VR-12) physical health score
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Other outcomes:
measure: Change of Veterans RAND 12 Item Health Survey (VR-12) single domains
timeFrame: 4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Locations:
city: Greifswald
country: Germany
facility: Department of Neurology
state: Mecklenburg-Vorpommern
Study officials:
References: