Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics - Full Text View

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

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- Dingemans, Michiels, Declercq
Reet, Belgium, 2840
GP - Goossens
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:

De Hertogh W, Vaes P, Devroey D, Louis P, Carpay H, Truijen S, Duquet W, Oostendorp R. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain. BMC Musculoskelet Disord. 2009 Sep 23;10(1):115 [Epub ahead of print]

De Hertogh WJ, Vaes PH, Vijverman V, De Cordt A, Duquet W. The clinical examination of neck pain patients: The validity of a group of tests. Man Ther. 2006 Jun 10; [Epub ahead of print]

De Hertogh WJ, Vaes PH, Devroey D, Truijen S, Duquet W, Oostendorp RA. Management of Headache Disorders: Design of a Randomised Clinical Trial Screening for Prognostic Patient Characteristics. BMC Musculoskelet Disord. 2007 Apr 26;8(1):38 [Epub ahead of print]

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
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013