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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 physiotherapis
• Поведенческое 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.

Первичные конечные точки

• Change in headache pain intensity [Срок оценки: Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]

Вторичные конечные точки (10)

• Change in headache frequency [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]
• Headache Impact Test (HIT-6) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]
• Quality of Life (SF-36) [Срок оценки: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]
• Insomnia Severity Index (ISI) [Срок оценки: Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

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

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07240532 · JBE-CEF-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗