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

Not Applicable

Terminated

• Conditions: Headache

• Registration Number: NCT00298142
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-03-01
• Study Completion: 2007-06
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-05
• Last Update Posted: 2009-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thermal stimulation
Perceived effect
HIT-6
Pressure algometry
Manual Examination of the Cervical Spine

Secondary Outcome Measures

Name	Time	Method
Frequency of headache
Intensity of headache
Medication Intake
Additional Profession help
Absenteism

Trial Locations

Locations (14)

UZA - Neurology Dept.; 🇧🇪 Antwerp, Belgium

GP-De Loof; 🇧🇪 Aalst, Belgium

GP-Roelants; 🇧🇪 Boom, Belgium

GP-Marmitte; 🇧🇪 Dilbeek, Belgium

GP-De Hertogh; 🇧🇪 Kampenhout, Belgium

GP - Sengeleng; 🇧🇪 Hamme, Belgium

GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille; 🇧🇪 Laarne, Belgium

GP - Riffi Abdellatif; 🇧🇪 Mechelen, Belgium

GP-Vande Voorde; 🇧🇪 Merchtem, Belgium

GP - Goossens; 🇧🇪 Reet, Belgium

GP- Dingemans, Michiels, Declercq; 🇧🇪 Reet, Belgium

GP-Van de Heijning; 🇧🇪 Schoten, Belgium

AZ-VUB; 🇧🇪 Brussels, Belgium

GP-Roelands; 🇧🇪 Zemst, Belgium