Effects of Multimodal Treatment of Headache in a Day Clinic Service

Headache Disorders Clinical Trial

Official title:

Effects of Multimodal Treatment of Headache in a Day Clinic Service: a Prospective Case-crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111873
• Other study ID #: BB004/21
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: October 2021
• Source: University Medicine Greifswald
• Contact: Robert Fleischmann, MD
• Phone: +493834866778
• Email: robert.fleischmann[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders

Intervention

Other:
• multimodal treatment
combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation

Locations

Country	Name	City	State
Germany	Department of Neurology	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Veterans RAND 12 Item Health Survey (VR-12) single domains	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	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Primary	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	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary	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	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary	Change of Headache Impact Test (HIT6)	questionnaire, patient self-report, minimum value: 36 points, maximum value: 78 points, higher score = worse outcome	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary	Change of Pain intensity	average pain intensity in the last month, scale 1 to 10, higher score = worse outcome	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary	Change of Headache frequency	in days per month, referring to the last month, minimum value: 0 days/month, maximum value: 30 days/month	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment
Secondary	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	4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment