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临床试验/NCT05839496
NCT05839496已完成不适用

Effects of Cervical Stabilization Training on Individuals With Headache

Gazi University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Pain intensity assessed by the VAS

研究概览

简要总结

Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. The effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.

详细描述

Headache is a common health problem. The most common headaches worldwide are migraine, tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical relationship between the head and the cervical region, neck pain accompanies these headaches. Most of the previous studies examined the effects of exercise programs such as Cranio-Cervical Flexion Exercises (CCFE), posture exercises, muscle strengthening, and stretching exercises of the neck and shoulder on headaches. These studies presented the beneficial effects of CCFE which mostly targeted strengthening the superficial neck and shoulder muscles. However, the effects of cervical stabilization training including all of the cervical regions, thoracic regions, and the upper extremities in individuals with headaches are not yet known.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •a clinical diagnosis of migraine, tension-type headache (TTH), and cervicogenic headache (CGH)
  • •age between 18 and 55 years
  • •being female
  • •frequency of headaches at least once a week or more in the last year

排除标准

  • •having a neurological and orthopedic disease such as Parkinson's, stroke, cognitive disorders, and temporomandibular joint dysfunction,
  • •having any contraindication for exercise,
  • •having any serious head and/or neck trauma,
  • •being with menopause,
  • •being included in a physiotherapy program for head and neck pain in the last 12 months.

研究组 & 干预措施

Cervical Stabilization Training Group

Experimental

The Cervical Stabilization Training Group applied cervical stabilization training three times a week for 8 weeks. Each session was completed in 45 minutes.

干预措施: Cervical stabilization exercises (Other)

Control Group

No Intervention

Control Group continued their medical treatment and they did not participate in any treatment for eight weeks.

结局指标

主要结局

Pain intensity assessed by the VAS

时间窗: Eight weeks

The average headache severity and neck pain severity in the last month was also assessed by using the Visual Analogue Scale (VAS). A Visual Analogue Scale (VAS) is one of the pain rating scales. A VAS consists of a line, often 10 cm long, with verbal anchors at either end (e.g., "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

Deep cervical flexor muscles strength assessed by the stabilizer pressure biofeedback

时间窗: Eight weeks

Cranio-Cervical Flexion Test : To begin the test, the patient is lying on a table in a supine position with their neck in a neutral position. A biofeedback stabilizer device is then placed under the patient's neck to rest against the occiput and inflated to a baseline pressure of 20 mmHg. During the test, the patient is asked to close their mouth with a slight gap between their jaws and place their tongue on the upper palate. They are then instructed to nod their head as if saying "yes." In the first stage of the test, the patient is asked to increase the pressure by 2 mmHg and maintain this position at 22 mmHg for 10 seconds. The patient is then asked to relax. In subsequent stages of the test, the pressure is reset to the initial pressure of 20 mmHg, and the patient is asked to perform the same head movement for 10 repetitions to create a pressure of 4, 6, 8, and 10 mmHg, respectively, and maintain the pressure for 10 seconds in each movement.

Endurance of cervical muscles assessed by the chronometer

时间窗: Eight weeks

During the endurance test of cervical flexors, the patient is lying supıne position with the therapist's hand placed under their head. They are then asked to bring their chin closer to their chest, lifting their head about 2.5 cm and holding that position. The time they are able to maintain the position is recorded in seconds. During the endurance test of cervical extensors, the patient is lying down with their heads bent downwards and their heads and chest hanging over the bed, with a 2-kg sandbag placed on the back of their necks. They are then asked to lift their heads to a neutral position and hold their position. The time they are able to maintain the position is recorded in seconds.

Forward head posture assessed by the craniovertebral angle

时间窗: Eight weeks

To evaluate the cervical posture, pictures were taken from the side to objectively measure the forward head posture. Patients were asked to stand straight and then relax while the camera was placed at shoulder level. After printing the pictures, the craniovertebral angle was measured to represent the degree of forward head posture. This angle was calculated by measuring the angle between a horizontal line drawn through the 7th cervical vertebra and a line connecting the tragus of the ear and C7 spinous process.

Cervical joint range of motion assessed by the cervical range of motion instrument

时间窗: Eight weeks

The cervical joint range of motion was evaluated with a cervical joint range of motion measuring device. Active range of motion was measured in cervical flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion. Joint range of motion measurements were measured while the patient was sitting normally in an armless chair with a backrest.

次要结局

  • Disability level (headache) assessed by migraine disability rating scale(Eight weeks)
  • Health-related quality of life assessed by the short form 36 quality of life scale(Eight weeks)
  • Disability level (neck pain) assessed by the neck disability index(Eight weeks)
  • Sleep quality assessed by the Pittsburgh sleep quality index(Eight weeks)
  • Mood assessed by the Beck depression inventory(Eight weeks)

研究者

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

Cagla Ozkul

Clinical associate professor

Gazi University

研究点 (1)

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