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Tension-Type HeadacheJBE-CEFNCT07240532

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

A study testing Multimodal Physiotherapy for Tension-Type Headache and Guided Meditation Using Insight Timer App in people with Tension-Type Headache and Chronic Tension-type Headache, run by Universidad de Granada at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Multimodal Physiotherapy for Tension-Type Headache and Guided Meditation Using Insight Timer App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteSpain
Study dates
Jul 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Spain1 site

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

    Granada, 18002

    Jihane Boudount El Kadaoui, PT, DO, PhD(c), 0034671767926, e.jihaneb@go.ugr.es

    Antonio Manuel Fernandez Perez, PhD, 0034958248030, fernandez@ugr.es

Other trials in Spain

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Multimodal Physiotherapy for Tension-Type Headache, Guided Meditation Using Insight Timer App
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
Medical subject headings
Tension-Type Headache, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal Physiotherapy for Tension-Type HeadacheOther

    Also called Physiotherapy Multimodal Program, Manual Therapy plus Dry Needling

    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.

  • Guided Meditation Using Insight Timer AppBehavioural

    Also called Mobile Mindfulness Meditation, Digital Mindfulness Training

    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.

Study groups in NCT07240532
Study groupRoleWhat they receive
Multimodal PhysiotherapyExperimentalParticipants 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.
Receives: Other: Multimodal Physiotherapy for Tension-Type Headache
Guided Meditation GroupExperimentalParticipants 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.
Receives: Behavioral: Guided Meditation Using Insight Timer App
Combined Multimodal Physiotherapy and Guided MeditationExperimentalParticipants 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).
Receives: Other: Multimodal Physiotherapy for Tension-Type Headache; Behavioral: Guided Meditation Using Insight Timer App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study startJul 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240532
Sponsor's protocol ID
JBE-CEF-2025
Acronym
JBE-CEF
Status last verified
May 2026
First submitted
16 Nov 2025
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 35229190

  • 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.

    PubMed 30813155

  • 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.

    PubMed 33609358

  • 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.

    PubMed 24711779

  • 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.

    PubMed 29863407

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Physiotherapy for Tension-Type Headache and Guided Meditation Using Insight Timer App in people with Tension-Type Headache and Chronic Tension-type Headache, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jihane Boudount El Kadaoui, PT, DO, PhD(c) (0034 671767926, e.jihaneb@go.ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in headache pain intensity (time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07240532, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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