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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 120
- Locations
- 23
- Primary Endpoint
- Thermal stimulation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Thermal stimulation
Perceived effect
HIT-6
Pressure algometry
Manual Examination of the Cervical Spine
Secondary Outcomes
- Frequency of headache
- Intensity of headache
- Medication Intake
- Additional Profession help
- Absenteism