Classification and treatment of myofascial headaches
The Classification of Myofascial Headache: a Cross-sectional Study. the Added Value of Dry Needling in the Treatment of Myofascial Headache: a Randomized Controlled Trial.
This study is testing different ways to understand and treat myofascial headaches, including using dry needling and manual therapy, to see how well they help with pain and daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT06100588 on ClinicalTrials.gov |
What this trial studies
This project includes a cross-sectional study and a randomized controlled trial aimed at understanding and treating different types of headaches, specifically tension-type, cervicogenic, and myofascial headaches. The cross-sectional study will compare various outcome parameters among these headache types and healthy controls to evaluate the effectiveness of the International Classification of Headache Disorders criteria. The randomized controlled trial will focus on the treatment of myofascial headaches using dry needling and manual therapy, assessing their impact on pain and disability. Participants will undergo clinical evaluations and complete questionnaires regarding their headache experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing myofascial headaches with specific inclusion criteria related to headache frequency and severity.
Not a fit: Patients with chronic headaches, migraines, or those with serious structural pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic criteria and treatment options for patients suffering from myofascial headaches.
How similar studies have performed: Previous studies have shown some success with dry needling for tension-type and cervicogenic headaches, but the application to myofascial headaches is less explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, Oost-Vlaanderen
- Universitair ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Barbara Cagnie, Prof. Dr. — University Ghent
- Study coordinator: Indra De Greef
- Email: indra.degreef@ugent.be
- Phone: +32 9 332 56 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.