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

N/ANot Yet RecruitingNCT07240532

Universidad de Granada78 enrolled

Overview

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.

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.

Study Type

Interventions

Multimodal Physiotherapy for Tension-Type HeadacheOTHER

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 AppBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

Secondary Outcomes

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.

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

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.

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)

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.