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HeadacheNCT00298142

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

A study of Headache, run by Vrije Universiteit Brussel at 14 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Headache
Type of treatment
Surgery or procedure
How many people
120 participants
Where
14 sitesBelgium
Study dates
Feb 2006to Jun 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Clusterheadache
  • Trigeminusneuralgia
  • Peripheral neuropathy
  • A history with neck surgery
  • Comorbidity with chronic muskuloskeletal pain like fibromyalgia
  • Radicular pain in the upper extremity
Show all 12Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Belgium14 sites

  • GP-De Loof

    Aalst

  • UZA - Neurology Dept.

    Antwerp, Antwerp, 2650

  • GP-Roelants

    Boom, 2850

  • AZ-VUB

    Brussels, Brussels Capital, 1090

  • GP-Marmitte

    Dilbeek, 1700

  • GP - Sengeleng

    Hamme, 9220

  • GP-De Hertogh

    Kampenhout

  • GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille

    Laarne

  • GP - Riffi Abdellatif

    Mechelen, 2800

  • GP-Vande Voorde

    Merchtem

  • GP - Goossens

    Reet, 2840

  • GP- Dingemans, Michiels, Declercq

    Reet, 2840

  • GP-Van de Heijning

    Schoten

  • GP-Roelands

    Zemst, 1980

Other trials in Belgium

About this study

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

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.

Conditions
Headache
Being tested
Usual Care provided by a medical doctor (GP or Neurologist), Usual care plus Physio-/ Manual Therapy
Keywords
Cervicogenic Headache, Migraine, Tension Type Headache
Medical subject headings
Headache, Post-Traumatic Headache, Migraine Disorders, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual Care provided by a medical doctor (GP or Neurologist)Procedure or surgery

  • Usual care plus Physio-/ Manual TherapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manual Examination of the Cervical Spine

  2. Pressure algometry

  3. Thermal stimulation

  4. Perceived effect

  5. HIT-6

Secondary outcomes (5)

  1. Frequency of headache

  2. Intensity of headache

  3. Medication Intake

  4. Additional Profession help

  5. Absenteism

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Study completionJun 2007

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00298142
Sponsor's protocol ID
Headache Trial
Other IDs
OZR-VUB 997, OZR-HA G 815
Status last verified
Oct 2009
First submitted
27 Feb 2006
Last updated
6 Oct 2009
Results posted
No

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. doi: 10.1016/j.math.2006.02.007.

    PubMed 16769236

  • 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.

    PubMed 17462091

  • 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.

    PubMed 19775434

Questions about this trial

What is this clinical trial studying?

A study of Headache, run by Vrije Universiteit Brussel at 14 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Manual Examination of the Cervical Spine. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00298142, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2009.

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