Clinical trial NCT00298142: Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Headache
Keywords: Cervicogenic Headache
Migraine
Tension Type Headache
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Hogeschool Antwerpen
First posted: 2006-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Manual Examination of the Cervical Spine
measure: Pressure algometry
measure: Thermal stimulation
measure: Perceived effect
measure: HIT-6
Secondary outcomes:
measure: Frequency of headache
measure: Intensity of headache
measure: Medication Intake
measure: Additional Profession help
measure: Absenteism
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: GP-De Loof
city: Antwerp
country: Belgium
facility: UZA - Neurology Dept.
city: Boom
country: Belgium
facility: GP-Roelants
city: Brussels
country: Belgium
facility: AZ-VUB
city: Dilbeek
country: Belgium
facility: GP-Marmitte
city: Hamme
country: Belgium
facility: GP - Sengeleng
city: Kampenhout
country: Belgium
facility: GP-De Hertogh
city: Laarne
country: Belgium
facility: GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
city: Mechelen
country: Belgium
facility: GP - Riffi Abdellatif
city: Merchtem
country: Belgium
facility: GP-Vande Voorde
city: Reet
country: Belgium
facility: GP - Goossens
city: Reet
country: Belgium
facility: GP- Dingemans, Michiels, Declercq
city: Schoten
country: Belgium
facility: GP-Van de Heijning
city: Zemst
country: Belgium
facility: GP-Roelands
Study officials:
affiliation: Vrije Universiteit Brussel
name: Willem De Hertogh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.math.2006.02.007.
citation: 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. doi: 10.1186/1471-2474-8-38.
citation: 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.