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

Primary Purpose

Headache

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Usual Care provided by a medical doctor (GP or Neurologist)
Usual care plus Physio-/ Manual Therapy
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Cervicogenic Headache, Migraine, Tension Type Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GP-De Loof
  • UZA - Neurology Dept.
  • GP-Roelants
  • AZ-VUB
  • GP-Marmitte
  • GP - Sengeleng
  • GP-De Hertogh
  • GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
  • GP - Riffi Abdellatif
  • GP-Vande Voorde
  • GP - Goossens
  • GP- Dingemans, Michiels, Declercq
  • GP-Van de Heijning
  • GP-Roelands

Outcomes

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

Full Information

First Posted
February 27, 2006
Last Updated
October 5, 2009
Sponsor
Vrije Universiteit Brussel
Collaborators
Hogeschool Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT00298142
Brief Title
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

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
Hogeschool Antwerpen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Cervicogenic Headache, Migraine, Tension Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Usual Care provided by a medical doctor (GP or Neurologist)
Intervention Type
Procedure
Intervention Name(s)
Usual care plus Physio-/ Manual Therapy
Primary Outcome Measure Information:
Title
Manual Examination of the Cervical Spine
Title
Pressure algometry
Title
Thermal stimulation
Title
Perceived effect
Title
HIT-6
Secondary Outcome Measure Information:
Title
Frequency of headache
Title
Intensity of headache
Title
Medication Intake
Title
Additional Profession help
Title
Absenteism

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem De Hertogh, MSc
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
GP-De Loof
City
Aalst
Country
Belgium
Facility Name
UZA - Neurology Dept.
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GP-Roelants
City
Boom
ZIP/Postal Code
2850
Country
Belgium
Facility Name
AZ-VUB
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
GP-Marmitte
City
Dilbeek
ZIP/Postal Code
1700
Country
Belgium
Facility Name
GP - Sengeleng
City
Hamme
ZIP/Postal Code
9220
Country
Belgium
Facility Name
GP-De Hertogh
City
Kampenhout
Country
Belgium
Facility Name
GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille
City
Laarne
Country
Belgium
Facility Name
GP - Riffi Abdellatif
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
GP-Vande Voorde
City
Merchtem
Country
Belgium
Facility Name
GP - Goossens
City
Reet
ZIP/Postal Code
2840
Country
Belgium
Facility Name
GP- Dingemans, Michiels, Declercq
City
Reet
ZIP/Postal Code
2840
Country
Belgium
Facility Name
GP-Van de Heijning
City
Schoten
Country
Belgium
Facility Name
GP-Roelands
City
Zemst
ZIP/Postal Code
1980
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
16769236
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.
Results Reference
background
PubMed Identifier
17462091
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.
Results Reference
background
PubMed Identifier
19775434
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.
Results Reference
result

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

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