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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

Tracking Information
First Submitted Date  ICMJE February 27, 2006
First Posted Date  ICMJE March 1, 2006
Last Update Posted Date October 6, 2009
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2006)
  • Manual Examination of the Cervical Spine
  • Pressure algometry
  • Thermal stimulation
  • Perceived effect
  • HIT-6
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2006)
  • Frequency of headache
  • Intensity of headache
  • Medication Intake
  • Additional Profession help
  • Absenteism
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • Procedure: Usual Care provided by a medical doctor (GP or Neurologist)
  • Procedure: Usual care plus Physio-/ Manual Therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: February 27, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00298142
Other Study ID Numbers  ICMJE Headache Trial
OZR-HA G 815
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Vrije Universiteit Brussel
Collaborators  ICMJE Hogeschool Antwerpen
Investigators  ICMJE
Principal Investigator: Willem De Hertogh, MSc Vrije Universiteit Brussel
PRS Account Vrije Universiteit Brussel
Verification Date October 2009

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