Efficacy of a Multimodal Physiotherapy Program and Mobile-App Guided Meditation in Adults With Frequent or Chronic Tension-Type Headache: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in headache pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the interventions, blinding of participants and investigators is not feasible. Most outcome measures are self-reported and collected through standardized procedures, while physical assessments are performed by the principal investigator following predefined protocols. Therefore, this study is conducted as an open-label randomized controlled trial.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Multimodal Physiotherapy for Tension-Type Headache (Other)
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.
干预措施: Guided Meditation Using Insight Timer App (Behavioral)
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).
干预措施: Multimodal Physiotherapy for Tension-Type Headache (Other)
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).
干预措施: Guided Meditation Using Insight Timer App (Behavioral)
结局指标
主要结局
Change in headache pain intensity
时间窗: 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.
次要结局
- Quality of Life (SF-36)(Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up))
- Change in headache frequency(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(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)(Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up))
- Headache Impact Test (HIT-6)(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)(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)(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)(Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up))
- Insomnia Severity Index (ISI)(Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up))
研究者
Jihane Boudount El Kadaoui
Principal Investigator
Universidad de Granada