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

Condition(s) studied

Investigational drug(s) / intervention(s)

Multimodal 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.

Guided 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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