Study Stopped
Insufficient enrollment
Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics
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
3 other identifiers
interventional
120
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2006
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedOctober 6, 2009
October 1, 2009
February 27, 2006
October 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Manual Examination of the Cervical Spine
Pressure algometry
Thermal stimulation
Perceived effect
HIT-6
Secondary Outcomes (5)
Frequency of headache
Intensity of headache
Medication Intake
Additional Profession help
Absenteism
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vrije Universiteit Brussellead
- Hogeschool Antwerpencollaborator
Study Sites (14)
UZA - Neurology Dept.
Antwerp, Antwerp, 2650, Belgium
AZ-VUB
Brussels, Brussels Capital, 1090, Belgium
GP-De Loof
Aalst, Belgium
GP-Roelants
Boom, 2850, Belgium
GP-Marmitte
Dilbeek, 1700, Belgium
GP - Sengeleng
Hamme, 9220, Belgium
GP-De Hertogh
Kampenhout, Belgium
GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
Laarne, Belgium
GP - Riffi Abdellatif
Mechelen, 2800, Belgium
GP-Vande Voorde
Merchtem, Belgium
GP - Goossens
Reet, 2840, Belgium
GP- Dingemans, Michiels, Declercq
Reet, 2840, Belgium
GP-Van de Heijning
Schoten, Belgium
GP-Roelands
Zemst, 1980, Belgium
Related Publications (3)
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.
PMID: 16769236BACKGROUNDDe 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.
PMID: 17462091BACKGROUNDDe 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.
PMID: 19775434RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Willem De Hertogh, MSc
Vrije Universiteit Brussel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2006
First Posted
March 1, 2006
Study Start
February 1, 2006
Study Completion
June 1, 2007
Last Updated
October 6, 2009
Record last verified: 2009-10