Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Fr… (NCT07240532) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache
Spain78 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to evaluate whether a multimodal physiotherapy program and guided meditation using a mobile app can help reduce headache pain and improve quality of life in adults with frequent or chronic tension-type headache. The study analyzes the effects of physical and psychological interventions applied both separately and in combination, so that the combined treatment addresses tension-type headache as a multifactorial condition influenced by biopsychophysiological factors, integrating physical and psychological strategies to improve participants' overall well-being.
The main questions it aims to answer are:
* Does multimodal physiotherapy lower the intensity and frequency of headaches?
* Does guided meditation through a mobile app help reduce stress and improve emotional well-being?
* Are the combined effects of physiotherapy and meditation greater than either intervention alone?
The study will compare:
* A group receiving multimodal physiotherapy sessions once a week for four weeks,
* A group practicing guided meditation with a mobile app for about 5 to 7 minutes daily,
* A group combining both physiotherapy and meditation.
Participants will:
* Attend clinical sessions or use the meditation app depending on group assignment,
* Complete short questionnaires about pain, stress, sleep, and daily functioning,
* Record headache episodes in a structured diary during the study period.
Who can participate
Age range
18 Years – 45 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:
* Diagnosis of frequent or chronic tension-type headache (TTH) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
* Ability to understand and communicate in Spanish sufficiently to follow instructions and complete questionnaires.
* Willingness to provide written informed consent and comply with study procedures.
Exclusion Criteria:
* Diagnosis of migraine or other primary or secondary headache disorders.
* Presence of red flags for manual therapy, including bone pathology, inflammatory disease, malignancy, neurological disorders, vestibular dysfunction, or skin infection in the cervical area.
* Fibromyalgia, pregnancy, or lactation.
* Use of pacemakers or implantable defibrillators.
* Recent medication adjustments, particularly involving psychotropic or chronic pain drugs.
* Severe psychiatric disorders (major depressive episode, bipolar disorder, schizophrenia, or other psychotic conditions).
* Previous physical treatment targeting the cranio-cervical region (manual therapy, dry needling, anesthetic blocks) within the last six months.
* Regular practice of meditation or mindfulness during the last six months.
* Participation in another clinical trial during the study period.
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.