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

October 5, 2009 updated by: Vrije Universiteit Brussel

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • GP-De Loof
      • Antwerp, Belgium, 2650
        • UZA - Neurology Dept.
      • Boom, Belgium, 2850
        • GP-Roelants
      • Brussels, Belgium, 1090
        • AZ-VUB
      • Dilbeek, Belgium, 1700
        • GP-Marmitte
      • Hamme, Belgium, 9220
        • GP - Sengeleng
      • Kampenhout, Belgium
        • GP-De Hertogh
      • Laarne, Belgium
        • GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
      • Mechelen, Belgium, 2800
        • GP - Riffi Abdellatif
      • Merchtem, Belgium
        • GP-Vande Voorde
      • Reet, Belgium, 2840
        • GP - Goossens
      • Reet, Belgium, 2840
        • GP- Dingemans, Michiels, Declercq
      • Schoten, Belgium
        • GP-Van de Heijning
      • Zemst, Belgium, 1980
        • GP-Roelands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Manual Examination of the Cervical Spine
Pressure algometry
Thermal stimulation
Perceived effect
HIT-6

Secondary Outcome Measures

Outcome Measure
Frequency of headache
Intensity of headache
Medication Intake
Additional Profession help
Absenteism

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Collaborators

Hogeschool Antwerpen

Investigators

  • Principal Investigator: Willem De Hertogh, MSc, Vrije Universiteit Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 5, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Headache Trial
  • OZR-VUB 997
  • OZR-HA G 815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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