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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Change from Baseline Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study will employ a double-blind design. Participants will be masked regarding their group allocation (manual therapy vs. multicomponent exercise). All baseline and post-intervention outcome assessments will be conducted by an independent outcome assessor who will be fully blinded to the participants' group assignments and intervention protocols. The student physiotherapists administering the treatment protocols will be blinded to all evaluation and assessment results to prevent operator bias.
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 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.
排除标准
- •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.
结局指标
主要结局
Change from Baseline Pain Intensity
时间窗: Baseline and Post-intervention (Week 4)
Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
Change from Baseline Central Sensitization Inventory Score
时间窗: 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.
Change from Baseline Tampa Scale for Kinesiophobia Score
时间窗: 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.
Change from Baseline Migraine Disability Assessment Score
时间窗: 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)
Change from Baseline Neck Disability Index Score
时间窗: 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).
次要结局
- Change from Baseline Suboccipital Muscle Thickness(Baseline and Post-intervention at 4 Weeks)
- Change from Baseline Cervical Joint Position Sense Error(Baseline and Post-intervention at 4 Weeks)
- Change from Baseline Head-Eye Movement Control Test Score(Baseline and Post-intervention at Week 4)
- Change from Baseline Deep Cervical Flexor Muscle Endurance(Baseline and Post-intervention (Week 4).)
- Change from Baseline Postural Balance Score(Baseline and Post-intervention at Week 4)
- Change from Baseline Cervical Range of Motion(Baseline and Post-intervention at 4 Weeks)
研究者
Borna Farhoomand
Physiotherapist
Pamukkale University