The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized C… (NCT06100588) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.
Belgium152 participantsStarted 2023-12-06
Plain-language 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 types: tension type (TTH), cervicogenic (CGH) and myofascial headache (MFH) as drafted by the International Classification of Headache Disorders (ICHD). Not only will these types be compared against each other, they will also be compared to healthy controls (HC).
The main research questions are:
* Are the criteria drafted by the International Classification of Headache Disorders (ICHD) discriminative for MFH?
* Are there differences between the headache types (and healthy controls) in pain \& disability scores, range of motion (ROM), muscle strength, muscle elasticity and hyperalgesia (=pain pressure threshold, PPT)?
Participants will :
* Fill out questionnaires about their pain and disability;
* Be clinically investigated by a physiotherapist (anamnesis, inspection, examination of movement and structures of the neck and head);
* Undergo a testing battery including neck ROM, neck muscle strength \& elasticity and PPT measurement of the C2 processus spinosus, the bilateral upper trapezius muscle and the tibialis anterior muscle of the dominant leg.
2. The goal of this randomized controlled study is to investigate the additional effect of dry needling in the treatment of MFH patients, as compared to a treatment consisting of manual techniques only. The main question it aims to answer is:
* Does manual therapy combined with dry needling provide an additional effect on pain, disability and functional outcomes in MFH patients, as compared to manual therapy alone?
After the baseline test (see part 1), participants with MFH will be randomly divided to receive 4 sessions over 4 weeks of MT or MT + DN. Hereafter, the baseline test is repeated at 1 week and 3 months post-treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-coagulant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.