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

University of Granada (UGR)

Status: Not yet enrolling

Conditions: Frequent Episodic Tension-Type Headache; Tension-Type Headache; Chronic Tension-type Headache

Treatments: Behavioral: Guided Meditation Using Insight Timer App; Other: Multimodal Physiotherapy for Tension-Type Headache

Study type: Interventional

Funder types: Other

Identifiers

NCT07240532

JBE-CEF-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Multimodal Physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Multimodal Physiotherapy for Tension-Type Headache

Guided Meditation Group

Experimental group

Description:

Participants in this group will use the Insight Timer mobile application to perform daily guided meditation sessions lasting approximately 5-7 minutes, focused on mindfulness, stress reduction, and sleep improvement. Only free, Spanish-language content from the app will be used. The program will last four weeks.

Treatment:

Behavioral: Guided Meditation Using Insight Timer App

Combined Multimodal Physiotherapy and Guided Meditation

Experimental group

Description:

Participants in this group will receive both interventions: one weekly session of multimodal physiotherapy for four weeks and daily guided meditation using the Insight Timer app (approximately 5-7 minutes per day).

Treatment:

Other: Multimodal Physiotherapy for Tension-Type Headache

Behavioral: Guided Meditation Using Insight Timer App