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.
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.
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.
Parallel
Multimodal Physiotherapy for Tension-Type Headache
Other interventionParticipants in this group will receive a multimodal physiotherapy program once a week for four weeks. Each session includes thoracic (T4-T7) and cervicothoracic (C7-T1) manipulation, suboccipital inhibition, deep dry needling of the upper trapezius and sternocleidomastoid muscles, specific massage (temporal, paracervical, and SCM muscles), and passive cervical mobilization in rotation and lateral flexion within a pain-free range. All procedures will be performed by an experienced physiotherapist.
Guided Meditation Using Insight Timer App
BehavioralParticipants in this group will use the Insight Timer mobile application to perform daily guided meditation sessions of approximately 5-7 minutes for four weeks. All sessions will use free Spanish-language content focused on mindfulness, stress reduction, and sleep improvement. Participants will receive written instructions to ensure adherence.
Change in headache pain intensity
Headache pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record NPRS scores for each headache episode in a structured headache diary throughout the study period (baseline, intervention, and follow-up). Weekly mean NPRS values will be calculated for statistical analysis.
Change in headache frequency
Headache frequency will be assessed as the number of days per week with headache, derived from the structured headache diary completed by participants throughout the study period. A headache day will be defined as any day in which the participant reports the presence of headache, regardless of intensity or duration.
Change in mean headache duration per episode
Headache duration will be assessed as the average number of hours per headache episode, derived from the structured headache diary completed by participants throughout the study period. A headache episode will be defined as a continuous period of headache separated by at least 24 hours without pain. The mean duration per episode will be calculated for analysis.
Headache Disability Inventory (HDI)
Headache-related disability will be assessed using the Headache Disability Inventory (HDI), which includes total and subscale scores (emotional and functional). Higher scores indicate greater headache-related disability.
Headache Impact Test (HIT-6)
Headache impact will be assessed using the Headache Impact Test (HIT-6), a validated questionnaire that measures the impact of headache on daily functioning and quality of life. Scores range from 36 to 78, with higher scores indicating greater impact.
Number of active and latent myofascial trigger points (TrPs)
The number of active and latent myofascial trigger points will be assessed bilaterally in the upper trapezius, sternocleidomastoid, temporalis, masseter, suboccipital, and splenius capitis muscles, following established diagnostic criteria. Trigger points will be classified as active if they reproduce the participant's usual pain pattern or latent if not recognized as familiar. The total number of trigger points will be recorded for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.
Pressure Pain Thresholds (PPT) using algometry
Pressure pain thresholds (PPT) will be measured bilaterally at one trigeminal point (temporal muscle), one extratrigeminal point (C5-C6 zygapophyseal joint), and two remote points (second metacarpal and tibialis anterior) using a calibrated electronic algometer. The pressure at which the sensation changes from pressure to pain will be recorded. Three measurements will be taken at each point, and the mean value will be used for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.
Cervical Range of Motion (CROM device)
Active cervical range of motion (CROM) will be assessed using the CROM device (Performance Attainment Associates, MN, USA), which measures flexion, extension, lateral flexion, and rotation in both the global and upper cervical spine. Two measurements will be taken for each movement, and the mean value will be used for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.
Patient Global Impression of Improvement (PGI-I)
Global perceived improvement will be assessed using the Patient Global Impression of Improvement (PGI-I), a 7-point Likert scale that evaluates the participant's perception of overall change after the intervention. Scores range from 1 (very much improved) to 7 (very much worse).
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