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

• ClinicalTrials.gov Identifier: NCT00298142
• Recruitment Status: Terminated
• First Posted: March 1, 2006
• Last Update Posted: October 6, 2009
• Sponsor: Vrije Universiteit Brussel
• Collaborator: Hogeschool Antwerpen
• Information provided by: Vrije Universiteit Brussel

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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;10:115. doi: 10.1186/1471-2474-10-115.

Other Publications:

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. 2007 Feb;12(1):50-5.

De Hertogh WJ, Vaes PH, Devroey D, Truijen S, Duquet W, Oostendorp R. Management of headache disorders: design of a randomised clinical trial screening for prognostic patient characteristics. BMC Musculoskelet Disord. 2007 Apr 26;8:38.

• ClinicalTrials.gov Identifier: NCT00298142
• Other Study ID Numbers: Headache Trial; OZR-VUB 997; OZR-HA G 815
• First Posted: March 1, 2006
• Last Update Posted: October 6, 2009
• Last Verified: October 2009

Keywords provided by Vrije Universiteit Brussel:

Cervicogenic Headache; Migraine; Tension Type Headache

Additional relevant MeSH terms:

Headache Disorders; Headache; Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases