J&R Global Medical Clinic S.L. (NICA 45193)
Granada, 18002, Spain
Location contact
Antonio Manuel Fernandez Perez, PhD
CONTACT
Jihane Boudount El Kadaoui, PT, DO, PhD(c)
CONTACT
Jihane Boudount El Kadaoui, PT, DO, PhD(c)
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07240532
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Granada, 18002, Spain
Antonio Manuel Fernandez Perez, PhD
CONTACT
Jihane Boudount El Kadaoui, PT, DO, PhD(c)
CONTACT
Jihane Boudount El Kadaoui, PT, DO, PhD(c)
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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.
Time frame: Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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).
Time frame: Baseline (Week 0)
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.
Contact information is provided by the study sponsor or research team.
Antonio Manuel Fernandez Perez, PhD
CONTACT
Jihane Boudount El Kadaoui, PT, DO, PhD(c)
CONTACT
Universidad de Granada
Other
Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache: A Randomized Clinical Trial
Acronym: JBE-CEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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