Effects of Multimodal Treatment of Headache in a Day Clinic Service

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.

Study Overview

• Status: Recruiting
• Conditions: Headache Disorders
• Intervention / Treatment: Other: multimodal treatment

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Robert Fleischmann, MD; Phone Number: +493834866778; Email: robert.fleischmann@uni-greifswald.de

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Recruiting
      • Department of Neurology
      • Contact: Robert Fleischmann, MD; Phone Number: +49-3834 86-6855; Email: robert.fleischmann@uni-greifswald.de
      • Principal Investigator: Robert Fleischmann, MD
      • Sub-Investigator: Nadja Fiebig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients seen in the neurological day clinic service will be screened for eligibility.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: multimodal treatment; combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; multimodal treatment; day clinic service
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: BB004/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No