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.
Tension-type headache (TTH) is one of the most prevalent primary headache disorders and a major cause of pain-related disability worldwide. Its multifactorial nature involves musculoskeletal, psychological, and neurophysiological mechanisms, leading to recurrent episodes of pain and functional impairment. Conventional management often provides limited relief, highlighting the need for integrative, non-pharmacological approaches. This randomized controlled clinical trial is designed to evaluate the efficacy of multimodal physiotherapy and guided meditation delivered through a mobile application, both separately and in combination, in adults with frequent or chronic TTH. The combined intervention is intended to address TTH as a multifactorial condition influenced by biopsychophysiological factors, integrating physical and psychological strategies to improve overall well-being. Participants will be randomly assigned to one of three groups: (1) multimodal physiotherapy, (2) guided meditation via a mobile app, or (3) combined treatment. The physiotherapy program includes manual therapy, dry needling, soft tissue techniques, and cervical mobilization, delivered once a week for four weeks. The meditation program consists of daily guided sessions of approximately 5-7 minutes using the free Spanish-language content of the Insight Timer app. Outcome measures will include pain intensity, headache-related disability, emotional state, sleep quality, mindfulness, and patient global impression of improvement, assessed at baseline, post-treatment, and at 3-month follow-up (and at 6 months if the study timeline allows). This study aims to provide evidence for an accessible, non-invasive, and cost-effective therapeutic approach that could enhance clinical management and quality of life in people with tension-type headache.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Participants 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 a physiotherapist with over ten years of clinical experience.
Participants 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.
J&R Global Medical Clinic S.L. (NICA 45193)
Granada, Spain
Change in headache pain intensity
Headache pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS, 0-10), where 0 = no pain and 10 = worst imaginable pain. Participants will record NPRS scores for each headache episode in a structured paper headache diary throughout the study (baseline, intervention, and follow-up). Weekly mean NPRS values will be calculated for statistical analysis.
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Change in headache frequency
Number of days per week with headache, derived from the structured headache diary.
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Change in mean headache duration per episode
Average number of hours per headache episode, derived from the diary.
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Headache Disability Inventory (HDI)
Total score and subscales (emotional and functional). Higher scores = greater disability.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Headache Impact Test (HIT-6)
Headache Impact Test (HIT-6)
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Beck Depression Inventory-II (BDI-II)
Measure of depressive symptoms (0-63). Higher scores indicate greater severity.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Perceived Stress Scale-10 (PSS-10)
Scores range 0-40; higher scores = greater perceived stress.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Five Facet Mindfulness Questionnaire (FFMQ-39)
Assesses five dimensions of mindfulness; total and subscale scores analyzed.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Quality of Life (SF-36)
Eight domains scored 0-100; higher values = better perceived health.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Pittsburgh Sleep Quality Index (PSQI)
Global score 0-21; higher values = poorer sleep quality.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Insomnia Severity Index (ISI)
Global score 0-28; higher values = greater insomnia severity.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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