The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.
Launched by UNIVERSITY GHENT · Oct 20, 2023
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying different types of headaches, specifically tension-type headaches, cervicogenic headaches, and myofascial headaches. The researchers want to see how these headaches differ in terms of pain, disability, and other factors, and how they compare to healthy individuals. They will ask participants to fill out questionnaires about their headaches and undergo physical exams to assess their neck movement and muscle strength.
If you or someone you know experiences less than 15 headache days a month, has had more than 5 bothersome headache episodes, and scores their pain above a 2 out of 10, you might be eligible to participate. The trial includes two parts: one where participants will be evaluated, and another where those with myofascial headaches will receive treatment. Some will get traditional manual therapy, while others will receive both manual therapy and dry needling (a treatment that involves inserting very fine needles into the skin). Participants will have follow-up assessments after 1 week and 3 months to see how well the treatments worked. It’s important to note that certain medical conditions and medications may exclude individuals from participating, so it's best to check the eligibility criteria carefully.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • \< 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 Criteria:
- • 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
About University Ghent
University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gent, Oost Vlaanderen, Belgium
Patients applied
Trial Officials
Barbara Cagnie, Prof. Dr.
Principal Investigator
University Ghent
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported