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

February 27, 2006
March 1, 2006
October 6, 2009
February 2006
Not Provided
  • Manual Examination of the Cervical Spine
  • Pressure algometry
  • Thermal stimulation
  • Perceived effect
  • HIT-6
Same as current
Complete list of historical versions of study NCT00298142 on Archive Site
  • Frequency of headache
  • Intensity of headache
  • Medication Intake
  • Additional Profession help
  • Absenteism
Same as current
Not Provided
Not Provided
Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: Usual Care provided by a medical doctor (GP or Neurologist)
  • Procedure: Usual care plus Physio-/ Manual Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Headache Trial
OZR-HA G 815
Not Provided
Not Provided
Not Provided
Not Provided
Vrije Universiteit Brussel
Hogeschool Antwerpen
Principal Investigator: Willem De Hertogh, MSc Vrije Universiteit Brussel
Vrije Universiteit Brussel
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP