Trial document




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  DRKS00009622

Trial Description

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Title

Musculoskeletal dysfunctions in patients with migraine or tension-type headaches

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

It is unclear whether problems in the cervical spine or neck muscles contribute to migraine or tension-type headaches. We are investigating whether there is a difference regarding such problems between patients suffering from headaches and persons without headaches.

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Brief Summary in Scientific Language

There is an ongoing scientific debate about the contribution of neuromusculoskeletal dysfunctions to headache syndromes. This study will investigate differences in musculoskeletal dysfunctions between patients with migraine or TTH and headache-free control participants using a blinded protocol.

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Organizational Data

  •   DRKS00009622
  •   2015/11/06
  •   [---]*
  •   yes
  •   Approved
  •   PV5011, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G43 -  Migraine
  •   G44.2 -  Tension-type headache
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Interventions/Observational Groups

  •   Physiotherapy examination of patients with migraine or TTH
  •   Physiotherapy examination of healthy control participants
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Blinded
  •   investigator/therapist
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cluster of tests identified in an international consensus procedure:
-head forward posture
-range of cervical movement
-range of thoracic movement
-upper cervical quadrant
-passive physiological cervical movements
-flexion-rotation test
-manual joint examination cervical spine and thoracic spine
-trigger point palpation
-cranio-cervical flexion test

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Secondary Outcome

Questionnaires:
-MIDAS (migraine associated disability)
-Neck Disability Index
-PHQ9 (depression)
-personal data: age, gender, headache history, headache frequency, duration, intensity, sports, BMI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/04
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Diagnosed with migraine or TTH by headache expert

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Exclusion Criteria

diagnosed pathology of the neck; neck pathology in the past 2 years; diagnosed psychiatric, rheumatoid or other neurological disease

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Institute of systems neuroscience
    • Ms.  Dr  Kerstin  Luedtke 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Dr  Kerstin  Luedtke 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Institute of systems neuroscience
    • Ms.  Dr  Kerstin  Luedtke 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.