Effects of Multimodal Treatment of Headache in a Day Clinic Service

NCT05111873 | Unknown

• 1 other identifier: BB004/21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache Disorders

Keywords

multimodal treatment; quality of life; day clinic service

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Depression Anxiety and Stress Scale (DASS)

  4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment

• Change of Headache Impact Test (HIT6)

  4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment

• Change of Pain intensity

  4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment

• Change of Headache frequency

  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

  4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment

Other Outcomes (1)

• Change of Veterans RAND 12 Item Health Survey (VR-12) single domains

  4 weeks prior to treatment appointment, day 1 of treatment, 3 month after the treatment

Study Arms (2)

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

Interventions

multimodal treatment OTHER

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

post-treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• premature interruption of the treatment
• repeated treatment

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Neurology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

MeSH Terms

Conditions

Headache Disorders

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Robert Fleischmann, MD

CONTACT

+493834866778; robert.fleischmann@uni-greifswald.de

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: November 8, 2021
• Study Start: February 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

DE (1)