Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics
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| ClinicalTrials.gov Identifier: NCT00298142 |
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Recruitment Status :
Terminated
(Insufficient enrollment)
First Posted : March 1, 2006
Last Update Posted : October 6, 2009
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Sponsor:
Vrije Universiteit Brussel
Collaborator:
Hogeschool Antwerpen
Information provided by:
Vrije Universiteit Brussel
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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 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 |
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
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
Other Publications:
| ClinicalTrials.gov Identifier: | NCT00298142 History of Changes |
| Other Study ID Numbers: |
Headache Trial OZR-VUB 997 OZR-HA G 815 |
| First Posted: | March 1, 2006 Key Record Dates |
| Last Update Posted: | October 6, 2009 |
| Last Verified: | October 2009 |
Keywords provided by Vrije Universiteit Brussel:
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Cervicogenic Headache Migraine Tension Type Headache |
Additional relevant MeSH terms:
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Headache Headache Disorders Pain Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases |