Headache Analysis and Intervention (PRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02887638|
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : May 19, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Headache||Other: Individual Profile Analysis (Physical therapy Intervention)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Posture-related Headache: Profile Analysis and Intervention|
|Actual Study Start Date :||January 8, 2018|
|Actual Primary Completion Date :||May 18, 2020|
|Actual Study Completion Date :||May 18, 2020|
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)
The Individual Profile Analysis consists of the following components:
No Intervention: asymptomatic controls
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.
- Sitting-posture-profile [ Time Frame: day 1 ]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)
- Pain-Profile [ Time Frame: day 1 ]'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).
- Sitting-posture-profile [ Time Frame: week 1 up to week 8 ]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)
- Headache-related medication-use, headache intensity, duration and frequency. [ Time Frame: week -4 up to week 8 ]Through the use of a specific diary the secondary outcomes will be evaluated.
- Impact of headache on the quality of life. [ Time Frame: week -4 up to week 8 ]The 'Headache Impact Test (HIT-6)' will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887638
|Genk, Belgium, 3600|
|Hasselt, Belgium, 3500|
|Leuven, Belgium, 3000|
|Heerlen, Netherlands, 6419|
|Orbis Medisch Centrum|
|Sittard, Netherlands, 6130 MB|