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

NCT07240532 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-05-11

No results posted yet for this 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.

Conditions

  • Tension-Type Headache
  • Chronic Tension-type Headache
  • Frequent Episodic Tension-Type Headache

Interventions

OTHER

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • Antonio Manuel Fernández Pérez, Pt, phD · Department of Physiotherapy, Faculty of Health Sciences, University of Granada

  • Dulce María Romero Ayuso, PhD · Department of Physiotherapy, Faculty of Health Sciences, University of Granada

  • JIHANE Boudount El Kadaoui, PT, DO, PhD(c) · Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240532 on ClinicalTrials.gov