Trial document




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  DRKS00009618

Trial Description

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Title

The role of physiotherapy for the treatment of migraine and tension-type headache

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients suffering from migraine will receive either 10x physiotherapy or 5 sessions of endurance training depending on their preference. This study is aiming to evaluate the effect of physiotherapy compared to a guideline recommended intervention. The main instrument to measure improvement will be headache days per 4 weeks. Additionally the study is aiming to predict whether physiotherapy will be beneficial by using manual examination of the upper cervical spine, previously identified as one of 11 tests that international experts have identified as clinically useful for headache patients.

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Brief Summary in Scientific Language

Patients diagnosed with migraine will be receive either 10x physiotherapy or 5 sessions of endurance training depending on their preference. This study is aiming to evaluate the effect of physiotherapy compared to a guideline recommended training program on the frequency of migraine. Additionally a clinical prediction rule will be evaluated to predict treatment outcome. Prediction will be based on the manual assessment of the upper cervical spine.

Patient preference was integrated into the study design, because a strong Patient preference for physiotherapy was noted during the pilot phase of this trial. Based on knowledge from the literature, this can result in performance bias with patients performing worse if randomised into an undesired treatment group.

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Organizational Data

  •   DRKS00009618
  •   2015/11/30
  •   [---]*
  •   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
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Interventions/Observational Groups

  •   10x physiotherapy, 2 appointments (30 mins) each week, therapist decides on appropriate techniques such as manual joint mobilisation, muscle techniques, exercises
  •   5x 60 Minutes aerobic exercise (1x per week during a period of 5 weeks)
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

headache days in the past 4 weeks as assessed by a headache diary. The relevant time periods are 4 weeks immediately prior to the first day of treatment and the 4 weeks immediately following the last day of treatment

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Secondary Outcome

- global perceived change (questionnaire)
- MIDAS (questionnaire)
- Neck disability index (questionnaire)
- average pain intensity (headache diary)
- number of required acute medication units in the past 4 weeks (headache diary)

All endpoints will be measured immediately after the final treatment, and 4, 8, 24 weeks after the final treatment.

Participants randomised to the aerobic exercise or the manual therapy group will fill out the same questionnaires at the same time points and will provide data from the headache diary.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/01/04
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• aged < 18 years
• episodic or chronic migraine with or without aura for a minimum of 2 years
• minimum frequency of 6 attacks per year

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Exclusion Criteria

• diagnosed cervical pathology (e.g. disc disease)
• cervical trauma within the past 2 years (e.g. whiplash associated disorder)
• rheumatoid disease
• diagnosed craniomandibular dysfunction
• diagnosed neurological or psychiatric disease

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Addresses

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    • Institut für systemische Neurowissenschaften
    • Kerstin  Lüdtke 
    • 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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    • Institut für systemische Neurowissenschaften
    • Ms.  Kerstin  Lüdtke 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • 53170   Bonn
    • Germany
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    •   [---]*
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    • Migraine Research Foundationund Deutsche Migräne und Kopfschmerzgesellschaft
    • 10021  New York City
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/05
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Trial Publications, Results and other Documents

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