Status:
RECRUITING
The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.
Lead Sponsor:
University Ghent
Conditions:
Tension-Type Headache
Cervicogenic Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This project comprises two studies; a cross-sectional study and a randomized controlled trial. 1. The goal of the cross-sectional study is to compare multiple outcome parameters in different headache...
Detailed Description
Although tension-type headache (TTH) and cervicogenic headache (CGH) are classified as two distinct headache types according to the International Classification of Headache Disorders (ICHD), there are...
Eligibility Criteria
Inclusion
- \< 15 headache days per month
- \> 5 episodes of the headache that gives hindrance
- Mean NPRS score for headache episodes \>2/10
- No history of whiplash
- No serious structural pathology
- No previous surgeries in the head/neck/shoulder region
- To be included in the RCT-part of the study:
- \- Fitting the ICHD criteria for MFH
Exclusion
- Diagnosis of migraine by a neurologist or as confirmed via the Headache Screening Questionnaire (HSQ) with the maximum score of 8/8.
- Chronic headache (\>15 headache days/month)
- Newly onset headache (\<5 previous episodes of new headache type)
- Whiplash or whiplash associated disorders
- Serious structural pathology (confirmed by medical imaging)
- Pain on both sides of the body, above and under the waist, (with a total score of 7 or more out of 10) (=Widespread pain)
- Cardiovascular/metabolic/systemic/neurological diseases
- Fibromyalgia, Chronic Fatigue Syndrome
- History of surgery in the head/neck or shoulder region
- Probable or definite neuropathic pain (according to the classification of Finnerup et al.)
- Traumatic onset of the complaints
- Pregnancy/given birth/breastfeeding in the preceding year
- Psychiatric illnesses or depression diagnosed by a psychiatrist and currently treated by a psychiatrist and/or medication.
- BMI \>30
- For all of RCT-patients, the following criteria will also lead to exclusion due to the dry needling intervention:
- Usage of heavy blood thinners or anti-coagulants (e.g. Marcoumar, Marevan, Sintrom)
- High risk of infection because of comorbidities (e.g. HIV, diabetes) or skin conditions in the neck region (e.g. psoriasis)
- Epilepsy
- Allergies for latex, nickel
- Needle phobia
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06100588
Start Date
December 6 2023
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
Universitair ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium, 9000