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

Headache Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00298142
• Other study ID #: Headache Trial
• Secondary ID: OZR-VUB 997OZR-H
• Status: Terminated
• Phase: N/A
• First received: February 27, 2006
• Last updated: October 5, 2009
• Start date: February 2006
• Est. completion date: June 2007

Study information

• Verified date: October 2009
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders

Intervention

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

• Usual care plus Physio-/ Manual Therapy

Locations

Country	Name	City	State
Belgium	GP-De Loof	Aalst
Belgium	UZA - Neurology Dept.	Antwerp
Belgium	GP-Roelants	Boom
Belgium	AZ-VUB	Brussels
Belgium	GP-Marmitte	Dilbeek
Belgium	GP - Sengeleng	Hamme
Belgium	GP-De Hertogh	Kampenhout
Belgium	GP- De Smet, De Leu, Van Watermeulen, Thienpont, Wille	Laarne
Belgium	GP - Riffi Abdellatif	Mechelen
Belgium	GP-Vande Voorde	Merchtem
Belgium	GP - Goossens	Reet
Belgium	GP- Dingemans, Michiels, Declercq	Reet
Belgium	GP-Van de Heijning	Schoten
Belgium	GP-Roelands	Zemst

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Hogeschool Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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 headac — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual Examination of the Cervical Spine
Primary	Pressure algometry
Primary	Thermal stimulation
Primary	Perceived effect
Primary	HIT-6
Secondary	Frequency of headache
Secondary	Intensity of headache
Secondary	Medication Intake
Secondary	Additional Profession help
Secondary	Absenteism