Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT07240532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache
Sponsor:
Universidad de Granada
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JBE-CEF
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: