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临床试验/NCT07168512
NCT07168512招募中不适用

"Myofascial Release With or Without Exercise for Cervicogenic Headache"

Al-Azhar University5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
5
主要终点
Cervical cobb angle

研究概览

简要总结

This study will investigate whether myofascial release therapy alone or in combination with therapeutic exercises can improve cervical spine alignment, measured by cervical Cobb angle on X-ray, in patients with cervicogenic headache. The research will also examine potential effects on sleep quality and psychological factors."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-55 years.
  • Clinical diagnosis of cervicogenic headache according to International Classification of Headache Disorders (ICHD-3) criteria (headache attributed to cervical disorder).

排除标准

  • History of major cervical spine pathology such as fracture, dislocation, congenital malformation, tumor, infection, or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis).
  • Previous cervical spine surgery or fusion at any level.
  • Red flag symptoms indicating serious pathology (e.g., progressive neurological deficit, unexplained weight loss, fever, history of cancer).
  • Systemic or neurological disorders that may affect neck function or headache (e.g., multiple sclerosis, Parkinson's disease).
  • Severe osteoporosis or metabolic bone disease that contraindicates cervical X-ray imaging.
  • Vascular disorders such as vertebrobasilar insufficiency or carotid artery disease.
  • Pregnancy or breastfeeding (due to radiation exposure during cervical radiography).
  • Unstable psychiatric conditions (e.g., severe depression, psychosis) that may interfere with participation or adherence.
  • Recent physiotherapy or manual therapy targeting the cervical region within the past 6 weeks, or planned during the study outside the protocol.
  • Use of botulinum toxin or steroid injections to the neck or head region in the past 6 months.
  • Contraindications to manual therapy or exercise (e.g., acute cervical disc herniation, severe myelopathy, unstable cardiovascular disease).
  • Inability to understand study procedures, comply with treatment sessions, or provide informed consent.
  • Symptoms of migraine, tension-type headache (TTH), or any other headache apart from cervicogenic headache.

研究组 & 干预措施

One group will receive exercises

Experimental

The intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs

干预措施: Exercises (Endurance and strengthening) (Other)

Exercises and Myofascial release technique

Experimental

The intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs in addition to myofasical release technique

干预措施: Exercises (Endurance and strengthening) (Other)

Exercises and Myofascial release technique

Experimental

The intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs in addition to myofasical release technique

干预措施: Myofascial release technique (Other)

Control

No Intervention

control ; only advices

结局指标

主要结局

Cervical cobb angle

时间窗: pre and post (6 weeks)

Hospital Anxiety and depression scale

时间窗: pre and 8 weeks post physiotherapy interventions

The Hospital Anxiety and Depression Scale (HADS) is a validated self-report screening tool developed to assess levels of anxiety and depression in patients, particularly in non-psychiatric hospital settings. It contains 14 items divided into two subscales: seven items for anxiety (HADS-A) and seven for depression (HADS-D). Each item is scored on a 4-point Likert scale ranging from 0 to 3, giving a maximum score of 21 for each subscale. Higher scores indicate greater symptom severity. Scores of 0-7 are generally considered normal, 8-10 suggest borderline (possible) anxiety or depression, and 11-21 indicate clinically significant levels. The HADS is widely used in clinical and research contexts due to its brevity, ease of administration, and ability to distinguish between anxiety and depression symptoms without being confounded by physical illness.

Cobb angle of cervical spine assessed by X Ray (Lateral)

时间窗: pre , and 8 weeks post physiotherapy intervention

Landmarks \& angle construction (C2-C7 Cobb) Draw a line along the inferior endplate of C2. Draw a line along the inferior endplate of C7. Erect perpendiculars to each line and measure the angle at their intersection (alternatively, measure the acute angle between the two endplate lines and subtract from 180°). Record the angle in degrees of lordosis (greater positive values = greater lordosis). Note the sign convention in your CRF and keep it consistent pre/post. Normal value is between 20\_40

次要结局

  • neck disability(pre and 8 weeks post physiotherapy interventions)
  • sleep quality(pre, and 8 weeks post physiotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mosab ALdabbas

mosab aldabbas

Al-Azhar University

研究点 (5)

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