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

NCT00298142 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-10-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Usual Care provided by a medical doctor (GP or Neurologist)

PROCEDURE

Usual care plus Physio-/ Manual Therapy

Sponsors & Collaborators

  • Hogeschool Antwerpen

    collaborator UNKNOWN

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • Willem De Hertogh, MSc · Vrije Universiteit Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2007-06-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298142 on ClinicalTrials.gov