Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache
2026年8月20日 更新者：Borna Farhoomand、Pamukkale University
Effects of Manual Therapy Versus Multicomponent Exercise on Sensorimotor Function, Suboccipital Muscle Thickness, and Central Sensitization in Cervicogenic Headache: A Double-Blind Randomized Controlled Trial
The purpose of this study is to compare the effects of manual therapy and a multicomponent exercise program on suboccipital muscle thickness, joint position sense, pain, central sensitization, balance, and kinesiophobia in patients diagnosed with cervicogenic headache.
Cervicogenic headache is a common secondary headache originating from dysfunction in the upper cervical spine. Dysfunction in the deep neck muscles, impaired neck joint awareness, and heightened pain sensitivity (central sensitization) are frequently observed in these patients. While both manual therapy and targeted exercise are used in physiotherapy practice, evidence regarding their direct comparative effects on suboccipital muscle morphology and somatosensory parameters remains limited.
Participants will be randomly assigned to one of two treatment groups for a duration of 4 weeks (12 sessions total):
- Manual Therapy Group: Receives joint mobilization, myofascial release, trigger point release, and suboccipital distraction targeting the cervical region.
- Multicomponent Exercise Group: Receives deep cervical flexor strengthening, cervical proprioception training, head-eye coordination training, and progressive balance exercises.
The main questions the study aims to answer are:
- Do manual therapy and multicomponent exercise improve suboccipital muscle thickness and cervical joint position sense in patients with cervicogenic headache?
- Is there a significant difference between manual therapy and multicomponent exercise in reducing pain intensity, central sensitization, disability, and fear of movement (kinesiophobia)? It is hypothesized that both intervention protocols will yield significant clinical improvements, with specific synergistic adaptations in muscle structure, somatosensory system processing, and pain-related fear.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
32
阶段
- 不适用
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
Inclusion Criteria:
- Diagnosis of cervicogenic headache by a specialist physician,
- Aged between 18 and 45 years,
- Ability to read and write (literate),
- Provision of signed informed consent to participate in the study.
Exclusion Criteria:
- History of head or neck surgery,
- History of spinal surgery,
- History of severe cardiac conditions or cardiac surgery that contraindicates exercise,
- History of ongoing or past malignancy,
- Diagnosis of psychiatric disorders,
- Diagnosis of migraine,
- Diagnosis of fibromyalgia,
- Having received medical (except analgesics), physical therapy, or other interventions (e.g., alternative medicine, massage therapy) for cervicogenic headache within the last 6 months,
- Engaging in regular exercise or attending an exercise facility within the last 6 months,
- Experiencing headaches strictly associated with the menstrual period,
- Investigator decision for exclusion based on ethical or clinical grounds,
- Communication problems interfering with evaluation and treatment.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Manual Therapy Group
Participants in this arm will receive 12 sessions of manual therapy (3 sessions per week for 4 weeks).
Interventions include upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the suboccipital and cervical region.
|
Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.
|
|
有源比较器：Multicomponent Exercise Group
Participants in this arm will receive 12 sessions of a multicomponent exercise program (3 sessions per week for 4 weeks).
Interventions include deep cervical flexor strengthening, cervical proprioception training, gaze stability/head-eye coordination exercises, and progressive postural balance training.
|
Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.
|
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 |
|---|---|---|
|
Change from Baseline Pain Intensity
大体时间：Baseline and Post-intervention (Week 4)
|
Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
|
Baseline and Post-intervention (Week 4)
|
|
Change from Baseline Central Sensitization Inventory Score
大体时间：Baseline and Post-intervention at 4 Weeks
|
Assessed using the 25-item Central Sensitization Inventory (CSI) with a total score ranging from 0 to 100 to evaluate the severity of central sensitization.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Tampa Scale for Kinesiophobia Score
大体时间：Baseline and Post-intervention at Week 4
|
Evaluated using the Tampa Scale for Kinesiophobia (TSK) 4-point Likert scale (17-68 score range) to measure fear of movement and re-injury.
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Migraine Disability Assessment Score
大体时间：Baseline and Post-intervention at 4 Weeks.
|
Assessed using the 5-item Migraine Disability Assessment (MIDAS) questionnaire to evaluate the total number of days with headache-related disability (score range 0 to 21+ for disability severity grades I to IV)
|
Baseline and Post-intervention at 4 Weeks.
|
|
Change from Baseline Neck Disability Index Score
大体时间：Baseline and Post-intervention at 4 Weeks
|
Evaluated using the 10-item Neck Disability Index (NDI) questionnaire to measure neck pain-related functional disability (score range 0 to 50, higher scores indicating higher disability).
|
Baseline and Post-intervention at 4 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Suboccipital Muscle Thickness
大体时间：Baseline and Post-intervention at 4 Weeks
|
Evaluated using B-mode ultrasonography (9-12 MHz linear probe) to measure the thickness (in millimeters) of the rectus capitis posterior major (RCPM) and obliquus capitis superior (OCS) muscles bilaterally at the C1-C2 level.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Cervical Joint Position Sense Error
大体时间：Baseline and Post-intervention at 4 Weeks
|
Evaluated using the Cervical Range of Motion (CROM) device to measure cervical joint position error (in degrees) at target angles set at 65% of the participant's active range of motion.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Head-Eye Movement Control Test Score
大体时间：Baseline and Post-intervention at Week 4
|
Evaluated using the Head-Eye Movements Control Test, scored as 0 (negative/stable), 1 (moderately positive), or 2 (strongly positive/unstable).
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Deep Cervical Flexor Muscle Endurance
大体时间：Baseline and Post-intervention (Week 4).
|
Assessed in seconds using the Cervical Deep Neck Flexor Muscle Endurance Test in a hook-lying chin tuck position.
|
Baseline and Post-intervention (Week 4).
|
|
Change from Baseline Postural Balance Score
大体时间：Baseline and Post-intervention at Week 4
|
Measured using the Sway mobile application across five stance positions (feet together, left/right tandem, left/right single-leg) under blindfolded conditions, producing a total balance score from 0 to 100.
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Cervical Range of Motion
大体时间：Baseline and Post-intervention at 4 Weeks
|
Evaluated using the Baseline CROM Deluxe device to measure active cervical flexion, extension, right/left lateral flexion, and right/left rotation in degrees.
Two trials will be performed for each movement and the arithmetic mean will be analyzed.
|
Baseline and Post-intervention at 4 Weeks
|
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。
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9月1日
初级完成 (估计的)
2027年2月28日
研究完成 (估计的)
2027年3月31日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月17日
首次发布 (实际的)
2026年8月20日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
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