多模式物理治疗计划和移动应用程序引导冥想对频繁或慢性紧张型头痛成人患者的疗效：一项随机对照试验 (JBE-CEF)
2026年5月5日 更新者：Jihane Boudount El Kadaoui、Universidad de Granada
多模式物理治疗方案与移动应用引导冥想对频繁或慢性紧张型头痛成人患者疗效的随机临床试验
本临床试验的目的是评估通过移动应用程序进行的多模式物理治疗项目和引导式冥想，是否有助于减轻频繁或慢性紧张型头痛成人的头痛疼痛并提高生活质量。 该研究分析分别和结合应用的生理和心理干预效果，使联合治疗能够将紧张型头痛作为一种受生物心理生理因素影响的多因素病症来应对，整合生理和心理策略以改善参与者的整体健康状况。
它旨在回答的主要问题是：
- 多模式物理治疗是否能降低头痛的强度和频率？
- 通过移动应用程序进行的引导式冥想是否有助于减轻压力并改善情绪健康？
- 物理治疗和冥想的联合效果是否大于单独任何一种干预？
研究将比较：
- 一组接受每周一次、为期四周的多模式物理治疗，
- 一组使用移动应用程序每天进行约5至7分钟的引导式冥想，
- 一组结合物理治疗和冥想。
参与者将：
- 根据分组安排参加临床治疗或使用冥想应用程序，
- 完成关于疼痛、压力、睡眠和日常功能的简短问卷，
- 在研究期间以结构化日记记录头痛发作情况。
研究概览
地位
尚未招聘
详细说明
紧张型头痛是最常见的原发性头痛疾病之一，也是全球范围内疼痛相关残疾的主要原因。 其多因素性质涉及肌肉骨骼、心理和神经生理机制，导致反复发作的疼痛和功能障碍。 传统治疗方法通常缓解效果有限，凸显了对综合性非药物方法的需求。
本随机对照临床试验旨在评估通过移动应用程序提供的多模式物理疗法和引导冥想，分别及联合应用于频繁或慢性紧张型头痛成人的疗效。 联合干预旨在将紧张型头痛视为受生物心理生理因素影响的多因素病症，整合身体和心理策略以改善整体健康状况。
受试者将被随机分配到三组之一：（1）多模式物理疗法组，（2）通过移动应用程序进行的引导冥想组，或（3）联合治疗组。 物理疗法方案包括手法治疗、干针、软组织技术和颈椎松动术，每周一次，持续四周。 冥想方案包括使用Insight Timer应用程序免费西班牙语内容进行的每日引导课程，时长约5-7分钟。
结局指标将包括疼痛强度、头痛相关残疾、情绪状态、睡眠质量、正念水平和患者整体改善印象，在基线、治疗后和3个月随访时（如果研究时间允许，还包括6个月随访）进行评估。
本研究旨在为紧张型头痛患者提供一种易于获取、非侵入性且成本效益高的治疗方法的证据，该方法可能改善临床管理和生活质量。
研究类型
介入性
注册 (估计的)
78
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jihane Boudount El Kadaoui, PT, DO, PhD(c)
- 电话号码：0034 671767926
- 邮箱：e.jihaneb@go.ugr.es
研究联系人备份
- 姓名：Antonio Manuel Fernandez Perez, PhD
- 电话号码：0034958248030
- 邮箱：fernandez@ugr.es
学习地点
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Granada、西班牙、18002
- J&R Global Medical Clinic S.L. (NICA 45193)
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接触：
- Antonio Manuel Fernandez Perez, PhD
- 电话号码：0034958248030
- 邮箱：fernandez@ugr.es
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接触：
- Jihane Boudount El Kadaoui, PT, DO, PhD(c)
- 电话号码：0034671767926
- 邮箱：e.jihaneb@go.ugr.es
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首席研究员：
- Jihane Boudount El Kadaoui, PT, DO, PhD(c)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
纳入标准：
- 根据国际头痛疾病分类第三版（ICHD-3）标准诊断为频繁或慢性紧张型头痛（TTH）。
- 能够充分理解和使用西班牙语进行交流，以遵循指示并完成问卷。
- 愿意提供书面知情同意并遵守研究程序。
排除标准：
- 诊断为偏头痛或其他原发性或继发性头痛疾病。
- 存在手动疗法的警示体征，包括骨骼病理、炎症性疾病、恶性肿瘤、神经系统疾病、前庭功能障碍或颈部区域皮肤感染。
- 纤维肌痛、妊娠或哺乳期。
- 使用起搏器或植入式除颤器。
- 近期药物调整，特别是涉及精神类或慢性疼痛药物。
- 严重精神疾病（重度抑郁发作、双相情感障碍、精神分裂症或其他精神病性状况）。
- 过去六个月内接受过针对颅颈区域的物理治疗（手动疗法、干针疗法、麻醉阻滞）。
- 过去六个月内定期进行冥想或正念练习。
- 研究期间参与另一项临床试验。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：多模式物理疗法
该组参与者将接受每周一次、为期四周的多模式物理治疗方案。
每次治疗包括胸椎（T4-T7）和颈胸椎（C7-T1）手法操作、枕下抑制、上斜方肌和胸锁乳突肌深层干针、特定按摩（颞肌、颈旁肌和SCM肌），以及在无痛范围内的被动颈椎旋转和侧屈活动。
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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.
其他名称：
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实验性的：引导冥想小组
该组参与者将使用Insight Timer移动应用程序进行每日指导冥想课程，每次约5-7分钟，专注于正念、减压和改善睡眠。
仅使用应用程序中免费的西班牙语内容。
该计划将持续四周。
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该组参与者将使用 Insight Timer 移动应用程序，在四周内每天进行约 5-7 分钟的引导式冥想课程。所有课程将使用免费的西班牙语内容，重点关注正念、压力缓解和睡眠改善。参与者将收到书面说明以确保依从性。
其他名称：
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实验性的：联合多模式物理疗法与引导冥想
该组参与者将接受两种干预措施：为期四周的每周一次多模式物理治疗课程，以及使用Insight Timer应用程序进行的每日引导冥想（每天约5-7分钟）。
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该组参与者将使用 Insight Timer 移动应用程序，在四周内每天进行约 5-7 分钟的引导式冥想课程。所有课程将使用免费的西班牙语内容，重点关注正念、压力缓解和睡眠改善。参与者将收到书面说明以确保依从性。
其他名称：
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in headache pain intensity
大体时间：Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in headache frequency
大体时间：Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Change in mean headache duration per episode
大体时间：Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Pre-allocation assessment, Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Headache Disability Inventory (HDI)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Headache Impact Test (HIT-6)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Beck Depression Inventory-II (BDI-II)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Perceived Stress Scale-10 (PSS-10)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Five Facet Mindfulness Questionnaire (FFMQ-39)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Quality of Life (SF-36)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Insomnia Severity Index (ISI)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of active and latent myofascial trigger points (TrPs)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Pressure Pain Thresholds (PPT) using algometry
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Cervical Range of Motion (CROM device)
大体时间：Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Patient Global Impression of Improvement (PGI-I)
大体时间：Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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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).
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Week 4 (post-treatment), Week 12 (3-month follow-up), Week 24 (6-month follow-up)
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Expectation of improvement (Likert 1-10)
大体时间：Baseline (Week 0)
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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.
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Baseline (Week 0)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Antonio Manuel Fernández Pérez, Pt, phD、Department of Physiotherapy, Faculty of Health Sciences, University of Granada
- 学习椅：Dulce María Romero Ayuso, PhD、Department of Physiotherapy, Faculty of Health Sciences, University of Granada
- 研究主任：JIHANE Boudount El Kadaoui, PT, DO, PhD(c)、Doctoral Program in Clinical Medicine and Public Health, University of Granada, Spain
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2025年11月16日
首先提交符合 QC 标准的
2025年11月16日
首次发布 (实际的)
2025年11月21日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- JBE-CEF-2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
个体参与者数据（IPD）将不会与其他研究人员共享。 所有数据将根据《通用数据保护条例》（EU 2016/679）和西班牙《数据保护基本法》3/2018号进行匿名化处理。
仅在同行评审期刊上发表或科学会议上展示经过汇总和去标识化的结果。
未计划向第三方传输原始数据，数据访问将仅限于格拉纳达大学研究团队，并受安达卢西亚地方生物医学研究伦理委员会的监督。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.