Chronic Tension-type Headache, Frequent Episodic Tension-Type Headache, Tension-Type Headache
Conditions
Keywords
Tension-Type Headache, Chronic Tension-Type Headache, Multimodal Physiotherapy, Manual Therapy, Dry Needling, Mindfulness, Guided Meditation, Mobile Application, Non-Pharmacological Treatment, Randomized Controlled Trial, Biopsychophysiological Approach;, Pain Management, Headache Disability
Brief 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.
Detailed description
This randomized controlled trial aims to evaluate the effectiveness of a multimodal physiotherapy program and guided meditation delivered via a mobile application in adults with frequent or chronic tension-type headache (TTH). Participants will be randomly assigned to one of three groups: (1) multimodal physiotherapy, (2) guided meditation using a mobile application, or (3) a combined intervention including both treatments. The physiotherapy intervention will consist of weekly sessions for four weeks, including manual therapy, dry needling, soft tissue techniques, and cervical mobilization. The meditation intervention will involve daily guided sessions of approximately 5-7 minutes using the Insight Timer mobile application. Primary and secondary outcomes will include headache intensity, frequency and duration, disability, emotional state, sleep quality, mindfulness, and global perceived improvement. Assessments will be conducted at baseline, post-treatment, and at 3-month follow-up (and at 6 months if feasible). This study aims to provide evidence on the effectiveness of a multimodal, non-pharmacological approach addressing both physical and psychological components of TTH.
Interventions
OTHERMultimodal Physiotherapy for Tension-Type Headache
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 an experienced physiotherapist.
BEHAVIORALGuided Meditation Using Insight Timer App
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.
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the interventions, blinding of participants and investigators is not feasible. Most outcome measures are self-reported and collected through standardized procedures, while physical assessments are performed by the principal investigator following predefined protocols. Therefore, this study is conducted as an open-label randomized controlled trial.
Intervention model description
This is a three-arm parallel randomized controlled trial with equal allocation (1:1:1). Participants will be randomly assigned to one of three groups: multimodal physiotherapy, guided meditation via mobile app, or combined treatment (physiotherapy plus meditation).
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache pain intensity | Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Insomnia severity will be assessed using the Insomnia Severity Index (ISI), a validated self-report questionnaire that evaluates the nature, severity, and impact of insomnia. The total score ranges from 0 to 28, with higher values indicating greater insomnia severity. |
| Change in headache frequency | Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | 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 | Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | 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) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | 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) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | 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. |
| Beck Depression Inventory-II (BDI-II) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a validated self-report questionnaire with scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. |
| Perceived Stress Scale-10 (PSS-10) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10), a validated self-report questionnaire with scores ranging from 0 to 40. Higher scores indicate greater perceived stress. |
| Five Facet Mindfulness Questionnaire (FFMQ-39) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ-39), a validated self-report instrument that evaluates five dimensions of mindfulness. Total and subscale scores will be analyzed, with higher scores indicating greater levels of mindfulness. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire that evaluates sleep quality over the past month. The global score ranges from 0 to 21, with higher values indicating poorer sleep quality. |
| Quality of Life (SF-36) | Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up) | Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36), a validated questionnaire that evaluates eight domains of perceived health. Scores range from 0 to 100, with higher values indicating better perceived health status. |
Countries
Spain
Contacts
CONTACTJihane Boudount El Kadaoui, PT, DO, PhD(c)
CONTACTAntonio Manuel Fernandez Perez, PhD
STUDY_CHAIRAntonio Manuel Fernández Pérez, Pt, phD
Department of Physiotherapy, Faculty of Health Sciences, University of Granada
STUDY_CHAIRDulce María Romero Ayuso, PhD
Department of Physiotherapy, Faculty of Health Sciences, University of Granada
STUDY_DIRECTORJIHANE Boudount El Kadaoui, PT, DO, PhD(c)
Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain
Outcome results
None listed