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Sponsors and Collaborators: |
Vrije Universiteit Brussel Hogeschool Antwerpen |
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Information provided by: | Vrije Universiteit Brussel |
ClinicalTrials.gov Identifier: | NCT00298142 |
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.
Condition | Intervention |
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Headache |
Procedure: Usual Care provided by a medical doctor (GP or Neurologist) Procedure: Usual care plus Physio-/ Manual Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 120 |
Study Start Date: | February 2006 |
Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
GP-Roelands | |
Zemst, Belgium, 1980 | |
GP-Marmitte | |
Dilbeek, Belgium, 1700 | |
GP-De Hertogh | |
Kampenhout, Belgium | |
GP-Vande Voorde | |
Merchtem, Belgium | |
GP- Dingemans, Michiels, Declercq | |
Reet, Belgium, 2840 | |
GP - Goossens | |
Reet, Belgium, 2840 | |
GP-Roelants | |
Boom, Belgium, 2850 | |
AZ-VUB | |
Brussels, Belgium, 1090 | |
GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille | |
Laarne, Belgium | |
GP-De Loof | |
Aalst, Belgium | |
GP-Van de Heijning | |
Schoten, Belgium | |
GP - Riffi Abdellatif | |
Mechelen, Belgium, 2800 | |
UZA - Neurology Dept. | |
Antwerp, Belgium, 2650 | |
GP - Sengeleng | |
Hamme, Belgium, 9220 |
Principal Investigator: | Willem De Hertogh, MSc | Vrije Universiteit Brussel |
Study ID Numbers: | Headache Trial, OZR-VUB 997, OZR-HA G 815 |
Study First Received: | February 27, 2006 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00298142 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Cervicogenic Headache Migraine Tension Type Headache |
Signs and Symptoms Migraine Disorders Tension-Type Headache Headache Central Nervous System Diseases |
Neurologic Manifestations Pain Brain Diseases Headache Disorders |
Nervous System Diseases |