NCT05111873|Unknown
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Sponsor study identifier
observational
50
1 country
1
Study Start
February 15, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2021
Actual (reported)July 12, 2021
Actual (reported)November 8, 2021
Actual (reported)April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
Participants enquired prior to the treatment appointment in the neurological day clinic service, no intervention
Participants enquired after the treatment in the Neurological day clinic service
combination of medical consultations, psychological therapy, physiotherapy, occupational therapy, disease specific education und progressive muscle relaxation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients seen in the neurological day clinic service will be screened for eligibility.
Department of Neurology
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
First Submitted
July 12, 2021
First Posted
November 8, 2021
Study Start
February 15, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Smartphone Use Restriction as Treatment of Primary Headache
Contact the study team to confirm eligibility.
Study Completion
May 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 8, 2021
Record last verified: 2021-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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