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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tension-Type Headache; Chronic Tension-type Headache; Frequent Episodic Tension-Type Headache
• Intervention / Treatment: Behavioral: Guided Meditation Using Insight Timer App; Other: Multimodal Physiotherapy for Tension-Type Headache

Detailed Description

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: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jihane Boudount El Kadaoui, PT, DO, PhD(c); Phone Number: 0034 671767926; Email: e.jihaneb@go.ugr.es
• Study Contact Backup: Name: Antonio Manuel Fernandez Perez, PhD; Phone Number: 0034958248030; Email: fernandez@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18002
    • J&R Global Medical Clinic S.L. (NICA 45193)
    • Contact: Antonio Manuel Fernandez Perez, PhD; Phone Number: 0034958248030; Email: fernandez@ugr.es
    • Contact: Jihane Boudount El Kadaoui, PT, DO, PhD(c); Phone Number: 0034671767926; Email: e.jihaneb@go.ugr.es
    • Principal Investigator: Jihane Boudount El Kadaoui, PT, DO, PhD(c)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Physiotherapy Multimodal Program; Manual Therapy plus Dry Needling
Experimental: 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.	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.; Other Names: Mobile Mindfulness Meditation; Digital Mindfulness Training
Experimental: 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).	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.; Other Names: Mobile Mindfulness Meditation; Digital Mindfulness Training; 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.; Other Names: Physiotherapy Multimodal Program; Manual Therapy plus Dry Needling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Headache Impact Test (HIT-6)	Headache impact will be assessed using the Headache Impact Test (HIT-6), a validated questionnaire that measures the impact of headache on daily functioning and quality of life. Scores range from 36 to 78, with higher scores indicating greater impact.	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)	Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a validated self-report questionnaire with scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Perceived Stress Scale-10 (PSS-10)	Perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10), a validated self-report questionnaire with scores ranging from 0 to 40. Higher scores indicate greater perceived stress.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Five Facet Mindfulness Questionnaire (FFMQ-39)	Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ-39), a validated self-report instrument that evaluates five dimensions of mindfulness. Total and subscale scores will be analyzed, with higher scores indicating greater levels of mindfulness.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Quality of Life (SF-36)	Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36), a validated questionnaire that evaluates eight domains of perceived health. Scores range from 0 to 100, with higher values indicating better perceived health status.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Pittsburgh Sleep Quality Index (PSQI)	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire that evaluates sleep quality over the past month. The global score ranges from 0 to 21, with higher values indicating poorer sleep quality.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Insomnia Severity Index (ISI)	Insomnia severity will be assessed using the Insomnia Severity Index (ISI), a validated self-report questionnaire that evaluates the nature, severity, and impact of insomnia. The total score ranges from 0 to 28, with higher values indicating greater insomnia severity.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of active and latent myofascial trigger points (TrPs)	The number of active and latent myofascial trigger points will be assessed bilaterally in the upper trapezius, sternocleidomastoid, temporalis, masseter, suboccipital, and splenius capitis muscles, following established diagnostic criteria. Trigger points will be classified as active if they reproduce the participant's usual pain pattern or latent if not recognized as familiar. The total number of trigger points will be recorded for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.	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	Pressure pain thresholds (PPT) will be measured bilaterally at one trigeminal point (temporal muscle), one extratrigeminal point (C5-C6 zygapophyseal joint), and two remote points (second metacarpal and tibialis anterior) using a calibrated electronic algometer. The pressure at which the sensation changes from pressure to pain will be recorded. Three measurements will be taken at each point, and the mean value will be used for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.	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)	Active cervical range of motion (CROM) will be assessed using the CROM device (Performance Attainment Associates, MN, USA), which measures flexion, extension, lateral flexion, and rotation in both the global and upper cervical spine. Two measurements will be taken for each movement, and the mean value will be used for analysis. Assessments will be performed by the principal investigator following standardized and predefined procedures. Blinding is not feasible due to the study design.	Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Patient Global Impression of Improvement (PGI-I)	Global perceived improvement will be assessed using the Patient Global Impression of Improvement (PGI-I), a 7-point Likert scale that evaluates the participant's perception of overall change after the intervention. Scores range from 1 (very much improved) to 7 (very much worse).	Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
Expectation of improvement (Likert 1-10)	Expectation of improvement will be assessed before treatment using a single 10-point Likert scale. Participants will rate the question: "How much do you think this treatment will help your headache?", where 1 indicates "not at all" and 10 indicates "very much". This variable will be analyzed as a potential covariate or predictor of treatment response.	Baseline (Week 0)

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Study Chair: 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 Director: JIHANE Boudount El Kadaoui, PT, DO, PhD(c), Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Dry Needling; Randomized Controlled Trial; Mobile Application; Pain Management; Manual Therapy; Tension-Type Headache; Chronic Tension-Type Headache; Non-Pharmacological Treatment; Guided Meditation; Multimodal Physiotherapy; Biopsychophysiological Approach;; Headache Disability
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Headache Disorders, Primary; Headache Disorders; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Tension-Type Headache; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Dry Needling; Musculoskeletal Manipulations
• Other Study ID Numbers: JBE-CEF-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers. All data will be anonymized and handled in accordance with the General Data Protection Regulation (EU 2016/679) and Spanish Organic Law 3/2018 on Data Protection.

Only aggregated and de-identified results will be published in peer-reviewed journals or presented at scientific conferences.

No transfer of raw data to third parties is planned, and data access will remain restricted to the research team at the University of Granada under the supervision of the local Biomedical Research Ethics Committee of Andalusia.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No