Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics

Study Overview
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Brief Summary
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The management of headache disorders is too often based upon trial and error or on personal beliefs and opinions. Seldom it is based on scientific arguments. Therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patients.A prospective cohortstudy is designed to identify these prognostic patient characteristics. After testing, 186 headache patients (migraine, tension type headache and cervicogenic headache) will be randomly allocated to one of two treatment groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire, Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy treatment. After six weeks of treatment subjects will complete the headache inventory list and the Headache Impact Test a second time. The perceived effect will be registered allowing the distinction between responders (positive effect) and non-responders (no effect or worse). Logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders. Secondly the additional value of the physio-/ manual therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.

Official Title
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A Prospective Randomised Clinical Trial to Investigate the Management of Headache Disorders. Study to Identify Prognostic Patient Characteristics and to Investigate the Additional Value of Physio-/Manual Therapy

Conditions
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Headache

Intervention / Treatment
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* Procedure: Usual Care provided by a medical doctor (GP or Neurologist)
* Procedure: Usual care plus Physio-/ Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dutch speaking Willing to participate At least 18 years old Combination of headache and neck pain Headache since at least two months and at least twice a month A combination of migraine, tension type headache and cervicogenic headache Exclusion Criteria: Clusterheadache Trigeminusneuralgia Peripheral neuropathy A history with neck surgery Comorbidity with chronic muskuloskeletal pain like fibromyalgia Radicular pain in the upper extremity Osteoarthritis Down Syndroom Physio/ manual therapy treatment in the last 12 months for this headache complaint. The use of prescribed medication (like NSAIDs and triptans) for this headache complaint during the last two months Pregnancy Red flags as described in the Dutch General Practitioners Headache Guideline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Usual Care provided by a medical doctor (GP or Neurologist)|nan|
|Procedure: Usual care plus Physio-/ Manual Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Examination of the Cervical Spine |  |  | 
| Pressure algometry |  |  | 
| Thermal stimulation |  |  | 
| Perceived effect |  |  | 
| HIT-6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of headache |  |  | 
| Intensity of headache |  |  | 
| Medication Intake |  |  | 
| Additional Profession help |  |  | 
| Absenteism |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervicogenic Headache, Migraine, Tension Type Headache