Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache

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.

• Multimodal Physiotherapy for Tension-Type Headache (Other), also known as Physiotherapy Multimodal Program, Manual Therapy plus Dry Needling: 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.
• Guided Meditation Using Insight Timer App (Behavioral), also known as Mobile Mindfulness Meditation, Digital Mindfulness Training: 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.

Primary outcomes

• 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 outcomes

• 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.
• 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.
• 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.
• 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.

Other outcomes

• Number of active and latent myofascial trigger points (TrPs) [Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]: 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 [Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]: 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) [Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]: 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) [Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]: 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).
• Expectation of improvement (Likert 1-10) [Baseline (Week 0)]: Expectation of improvement will be assessed before treatment using a single 10-point Likert scale. Participants will rate the question: "How much do you think this treatment will help your headache?", where 1 indicates "not at all" and 10 indicates "very much". This variable will be analyzed as a potential covariate or predictor of treatment response.

Sex: All, ages: 18 Years to 45 Years

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.

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• Antonio Manuel Fernández Pérez, Pt, phD, Study chair, Department of Physiotherapy, Faculty of Health Sciences, University of Granada
• Dulce María Romero Ayuso, PhD, Study chair, Department of Physiotherapy, Faculty of Health Sciences, University of Granada
• JIHANE Boudount El Kadaoui, PT, DO, PhD(c), Study director, Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain