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

NCT07240532 | Not Yet Recruiting

• 1 other identifier: JBE-CEF-2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tension-Type Headache; Chronic Tension-Type Headache; Multimodal Physiotherapy; Manual Therapy; Dry Needling; Mindfulness; Guided Meditation; Mobile Application; Non-Pharmacological Treatment; Randomized Controlled Trial; Biopsychophysiological Approach;; Pain Management; Headache Disability

Outcome Measures

Primary Outcomes (1)

• Change in headache pain intensity

  Headache pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS, 0-10), where 0 = no pain and 10 = worst imaginable pain. Participants will record NPRS scores for each headache episode in a structured paper headache diary throughout the study (baseline, intervention, and follow-up). Weekly mean NPRS values will be calculated for statistical analysis.

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

Secondary Outcomes (10)

• Change in headache frequency

  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

  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)

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

• Headache Impact Test (HIT-6)

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

• Beck Depression Inventory-II (BDI-II)

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

Other Outcomes (5)

• Number of active and latent myofascial trigger points (TrPs)

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

• Pressure Pain Thresholds (PPT) using algometry

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

• Cervical Range of Motion (CROM device)

  Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

Study Arms (3)

Multimodal Physiotherapy

EXPERIMENTAL

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.

Other: Multimodal Physiotherapy for Tension-Type Headache

Guided Meditation Group

EXPERIMENTAL

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.

Behavioral: Guided Meditation Using Insight Timer App

Combined Multimodal Physiotherapy and Guided Meditation

EXPERIMENTAL

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).

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

Interventions

Multimodal Physiotherapy for Tension-Type Headache 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.

Also known as: Physiotherapy Multimodal Program, Manual Therapy plus Dry Needling

Combined Multimodal Physiotherapy and Guided Meditation; Multimodal Physiotherapy

Guided Meditation Using Insight Timer App 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.

Also known as: Mobile Mindfulness Meditation, Digital Mindfulness Training

Combined Multimodal Physiotherapy and Guided Meditation; Guided Meditation Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

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

Granada, 18002, Spain

Location

Related Publications (5)

• 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.

  PMID: 35229190 BACKGROUND

• 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.

  PMID: 30813155 BACKGROUND

• 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.

  PMID: 33609358 BACKGROUND

• 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.

  PMID: 24711779 BACKGROUND

• 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.

  PMID: 29863407 BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache; Agnosia

Interventions

Musculoskeletal Manipulations; Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Antonio Manuel Fernández Pérez, Pt, phD

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

  STUDY CHAIR

• Dulce María Romero Ayuso, PhD

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

  STUDY CHAIR

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

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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

0034 671767926; e.jihaneb@go.ugr.es

Antonio Manuel Fernandez Perez, PhD

CONTACT

0034958248030; fernandez@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to their group assignment to minimize expectation bias. Outcome assessors will also be blinded to intervention allocation. Therapists and investigators will not be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a three-arm parallel randomized controlled trial with equal allocation (1:1:1). Participants will be randomly assigned to one of three groups: multimodal physiotherapy, guided meditation via mobile app, or combined treatment (physiotherapy plus meditation).

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)