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

Vrije Universiteit Brussel

Status

Terminated

Conditions

Headache

Treatments

Procedure: Usual care plus Physio-/ Manual Therapy

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00298142

OZR-VUB 997

OZR-HA G 815

Headache Trial

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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