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

NCT ID: NCT07240532

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multimodal Physiotherapy

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.

Group Type: EXPERIMENTAL

Multimodal Physiotherapy for Tension-Type Headache

Intervention Type: OTHER

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 a physiotherapist with over ten years of clinical experience.

Guided Meditation Group

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.

Group Type: EXPERIMENTAL

Guided Meditation Using Insight Timer App

Intervention Type: BEHAVIORAL

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.

Combined Multimodal Physiotherapy and Guided Meditation

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).

Group Type: EXPERIMENTAL

Multimodal Physiotherapy for Tension-Type Headache

Intervention Type: OTHER

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 a physiotherapist with over ten years of clinical experience.

Guided Meditation Using Insight Timer App

Intervention Type: BEHAVIORAL

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.

Interventions

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 a physiotherapist with over ten years of clinical experience.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physiotherapy Multimodal Program; Manual Therapy plus Dry Needling; Mobile Mindfulness Meditation; Digital Mindfulness Training

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Jihane Boudount El Kadaoui

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Manuel Fernández Pérez, Pt, phD

Role: STUDY_CHAIR

Department of Physiotherapy, Faculty of Health Sciences, University of Granada

Dulce María Romero Ayuso, PhD

Role: STUDY_CHAIR

Department of Physiotherapy, Faculty of Health Sciences, University of Granada

JIHANE Boudount El Kadaoui, PT, DO, PhD(c)

Role: STUDY_DIRECTOR

Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain

Locations

J&R Global Medical Clinic S.L. (NICA 45193)

Granada, , Spain

Countries

Spain

Central Contacts

Jihane Boudount El Kadaoui, PT, DO, PhD(c)

Role: CONTACT

e.jihaneb@go.ugr.es

0034 671767926

Antonio Manuel Fernandez Perez, PhD

Role: CONTACT

fernandez@ugr.es

0034958248030

Facility Contacts

Jihane Boudount El Kadaoui, PT, DO, PhD(c)

Role: primary

e.jihaneb@go.ugr.es

0034671767926

Antonio Manuel Fernandez Perez, PhD

Role: backup

fernandez@ugr.es

0034958248030

References

Anheyer D, Leach MJ, Klose P, Dobos G, Cramer H. Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis. Cephalalgia. 2019 Apr;39(4):544-555. doi: 10.1177/0333102418781795. Epub 2018 Jun 4.

Reference Type: BACKGROUND

PMID: 29863407 (View on PubMed)

Fernandez-de-Las-Penas C, Palacios-Cena M, Valera-Calero JA, Cuadrado ML, Guerrero-Peral A, Pareja JA, Arendt-Nielsen L, Varol U. Understanding the interaction between clinical, emotional and psychophysical outcomes underlying tension-type headache: a network analysis approach. J Neurol. 2022 Aug;269(8):4525-4534. doi: 10.1007/s00415-022-11039-5. Epub 2022 Mar 1.

Reference Type: BACKGROUND

PMID: 35229190 (View on PubMed)

Gildir S, Tuzun EH, Eroglu G, Eker L. A randomized trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine (Baltimore). 2019 Feb;98(8):e14520. doi: 10.1097/MD.0000000000014520.

Reference Type: BACKGROUND

PMID: 30813155 (View on PubMed)

Pourahmadi M, Dommerholt J, Fernandez-de-Las-Penas C, Koes BW, Mohseni-Bandpei MA, Mansournia MA, Delavari S, Keshtkar A, Bahramian M. Dry Needling for the Treatment of Tension-Type, Cervicogenic, or Migraine Headaches: A Systematic Review and Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab068. doi: 10.1093/ptj/pzab068.

Reference Type: BACKGROUND

PMID: 33609358 (View on PubMed)

Espi-Lopez GV, Gomez-Conesa A. Efficacy of manual and manipulative therapy in the perception of pain and cervical motion in patients with tension-type headache: a randomized, controlled clinical trial. J Chiropr Med. 2014 Mar;13(1):4-13. doi: 10.1016/j.jcm.2014.01.004.

Reference Type: BACKGROUND

PMID: 24711779 (View on PubMed)

Other Identifiers

JBE-CEF-2025

Identifier Type: -

Identifier Source: org_study_id