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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Collaborator:
Hogeschool Antwerpen
Information provided by:
Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT00298142
First received: February 27, 2006
Last updated: October 5, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Headache
 Procedure: Usual Care provided by a medical doctor (GP or Neurologist)
Procedure: Usual care plus Physio-/ Manual Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • Manual Examination of the Cervical Spine
  • Pressure algometry
  • Thermal stimulation
  • Perceived effect
  • HIT-6

Secondary Outcome Measures:
  • Frequency of headache
  • Intensity of headache
  • Medication Intake
  • Additional Profession help
  • Absenteism
Estimated Enrollment: 120
Study Start Date: February 2006
Study Completion Date: June 2007
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298142

Locations
Belgium
GP-De Loof
Aalst, Belgium
UZA - Neurology Dept.
Antwerp, Belgium, 2650
GP-Roelants
Boom, Belgium, 2850
AZ-VUB
Brussels, Belgium, 1090
GP-Marmitte
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
GP-Roelands
Zemst, Belgium, 1980
Sponsors and Collaborators
Vrije Universiteit Brussel
Hogeschool Antwerpen
Investigators
Principal Investigator: Willem De Hertogh, MSc Vrije Universiteit Brussel
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00298142     History of Changes
Other Study ID Numbers: Headache Trial, OZR-VUB 997, OZR-HA G 815
Study First Received: February 27, 2006
Last Updated: October 5, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Vrije Universiteit Brussel:
Cervicogenic Headache
Migraine
Tension Type Headache

Additional relevant MeSH terms:
Headache
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015