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

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. Identifier: NCT00298142
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : March 1, 2006
Last Update Posted : October 6, 2009
Hogeschool Antwerpen
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Headache Procedure: Usual Care provided by a medical doctor (GP or Neurologist) Procedure: Usual care plus Physio-/ Manual Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache

Primary Outcome Measures :
  1. Manual Examination of the Cervical Spine
  2. Pressure algometry
  3. Thermal stimulation
  4. Perceived effect
  5. HIT-6

Secondary Outcome Measures :
  1. Frequency of headache
  2. Intensity of headache
  3. Medication Intake
  4. Additional Profession help
  5. Absenteism

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00298142

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GP-De Loof
Aalst, Belgium
UZA - Neurology Dept.
Antwerp, Belgium, 2650
Boom, Belgium, 2850
Brussels, Belgium, 1090
Dilbeek, Belgium, 1700
GP - Sengeleng
Hamme, Belgium, 9220
GP-De Hertogh
Kampenhout, Belgium
GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
Laarne, Belgium
GP - Riffi Abdellatif
Mechelen, Belgium, 2800
GP-Vande Voorde
Merchtem, Belgium
GP - Goossens
Reet, Belgium, 2840
GP- Dingemans, Michiels, Declercq
Reet, Belgium, 2840
GP-Van de Heijning
Schoten, Belgium
Zemst, Belgium, 1980
Sponsors and Collaborators
Vrije Universiteit Brussel
Hogeschool Antwerpen
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Principal Investigator: Willem De Hertogh, MSc Vrije Universiteit Brussel
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00298142    
Other Study ID Numbers: Headache Trial
OZR-HA G 815
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009
Keywords provided by Vrije Universiteit Brussel:
Cervicogenic Headache
Tension Type Headache
Additional relevant MeSH terms:
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Headache Disorders
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases