Headache Analysis and Intervention

Study Overview
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Brief Summary
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Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. Current therapies are therefore not as effective and the population of patients with PRH keeps on increasing. The diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. This goal can be achieved through fundamental research with a clinically oriented background. Our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to play an important role in PRH, the first step in the diagnostic process is to analyse postural differences between a PRH- and a control-group. In addition, the role of the dura mater in the headache-process will be examined. Patients with PRH will be classified in homogeneous groups based on these results. In a second phase individual-specific treatment programs will be composed. The general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific low back pain). Our study is divided in 2 phases: phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls) phase 2: interventional phase (clustered headache-groups, based on the results of phase 1

Official Title
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Posture-related Headache: Profile Analysis and Intervention

Conditions
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Headache

Intervention / Treatment
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* Other: Individual Profile Analysis (Physical therapy Intervention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Headache-group: Males and females between 20 and 50 years Confirmed medical diagnosis of tension-type headache, cervicogenic headache or a mixture Headache can be provoked by awkward cervical and/or head postures Exclusion Criteria Headache-group: Pregnancy History of pericranial surgery Serious pathology (neurological/cardiovascular/endocrine/musculoskeletal) Red flags Physical or manual therapy treatment for headache < 4 weeks prior the study Excessive (> 10 days/month for > 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics Psychiatric comorbidity Visual or temporo-mandibular dysfunction Inclusion Criteria Control-group: Males and females between 20 and 50 years Asymptomatic, no headache-history Exclusion Criteria Control-group: Pregnancy History of pericranial surgery Excessive (> 10 days/month for > 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics Visual or temporo-mandibular dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: headache<br>Patients diagnosed (neurologist - anesthesiologist - manual therapist) with tension-type and/or cervicogenic headache. During a first phase the sitting-posture, dura mater profile and pain-profile of the Headache-group will be analyzed. In a second phase, the patients will be sub-classified according to the data-analysis and receive intervention (Individual Profile Analysis +Physical therapy Intervention) | Other: Individual Profile Analysis (Physical therapy Intervention)<br>* The Individual Profile Analysis consists of the following components: Analysis of the sitting-posture profile: o cervical spine, thoracic spine, lumbar spine and pelvis during a longitudinal provoking task (working at a laptop). Analysis of the dural profile before and after the provoking task: o Determination of the dural sensitivity by the use of the slump-test Analysis of the pain profile before and after the provoking task: Determination of pressure pain sensitivity by the use of pressure algometry Determination of the influence of pain on the quality of life by the use of the HIT-6 questionnaire<br>|
| No Intervention: asymptomatic controls<br>Asymptomatic controls, matched for gender and age. During a first phase the sitting-posture, dura mater profile and pain-profile of the control-group will be analyzed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting-posture-profile | Sitting-posture will be measured with a 3D-video analysis (Bonita, ©Vicon Motion Systems Ltd. UK). Markers are placed on specific anatomical reference points on the participant. Afterwards angles (°) will be automatically calculated (Nexus, ©Vicon Motion Systems Ltd. UK) | day 1 | 
| Pain-Profile | 'Pain Pressure Threshold' will be measured. Through pressure- algometry (a) 'Pressure Pain Detection Threshold' (kPa/cm²) and (b) 'Pressure Pain Tolerance' (sec) will be determined (Somedic Sales AB, Stockholm Sweden). | day 1 | 
| Sitting-posture-profile | Sitting-posture will be measured with a 3D-video analysis (Bonita, ©Vicon Motion Systems Ltd. UK). Markers are placed on specific anatomical reference points on the participant. Afterwards angles (°) will be automatically calculated (Nexus, ©Vicon Motion Systems Ltd. UK) | week 1 up to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache-related medication-use, headache intensity, duration and frequency. | Through the use of a specific diary the secondary outcomes will be evaluated. | week -4 up to week 8 | 
| Impact of headache on the quality of life. | The 'Headache Impact Test (HIT-6)' will be used. | week -4 up to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posture, sit