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临床试验/NCT05397977
NCT05397977Unknown不适用

Comparison of the Effects of Mechanical Traction and Manual Traction on Pain, Muscle Tone and Functionality in Persons With Cervicogenic Headache

Istinye University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Mc-Gill Melzack Pain Questionnaire change

研究概览

简要总结

52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).

After obtaining the demographic information of the individuals to be included in the study, the cases will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.

The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.

Intermittent traction with chattanooga tru trac traction device will be applied to CTG, and manual traction, one of Cyriax's neck mobilization techniques, will be applied to MTG.transcutaneous electrical nerve stimulation (TENS), hotpack and ultrasound will be applied to both groups, and an exercise program will be given in the form of a home program.

详细描述

Cervicogenic headache (CGH) is a unilateral chronic pain that begins in the neck and neck and radiates to the back of the head. Pain in the CGH originates from structures in the cervical region innervated by the C1-C3 spinal nerves. Therefore, possible causes of CGH: Art. atlantooccipital, art. atlantoaxialis, C2-C3 art. It is related to dysfunctions arising from zygapophysial , C2-C3 discus intervertebral, upper cervical spinal nerves and their roots, skeletal muscles, connective tissue and neurovascular structures in the region.

The aim of this study was to compare the effects of mechanical traction and manual traction on pain, muscle tone and functionality in cervicogenic headache.

52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).

After obtaining the sociodemographic information of the individuals to be included in the study, the patients will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.

The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-45
  • having neck or headache for at least 3 months meets the diagnostic criteria for cervicogenic headache.
  • Unilateral pain
  • Decreased neck range of motion
  • Ipsilateral shoulder discomfort
  • Ipsilateral arm discomfort
  • Pain increase with different neck movements and pain with palpation eligible persons will be included.

排除标准

  • cluster headache
  • cervical radiculopathy,
  • entrapment neuropathy,
  • myelopathy,
  • rheumatoid arthritis,
  • undergo cervical spinal surgery,
  • to be pregnant,
  • have a whiplash injury
  • those who received physical therapy within 6 months will not be included in the study.
  • In cases where mechanical traction is contraindicated (inflammatory joint diseases, osteoporosis, acute inflammatory conditions, acute strain and injury, vertebrobasilar artery failure of the circulation, such as stroke or transient ischemic attack. abnormal upper motor neuron lesions, cardiovascular diseases, malignant tumoral conditions) will not be included.

结局指标

主要结局

Mc-Gill Melzack Pain Questionnaire change

时间窗: change from baseline Mc-Gill Melzack Pain Questionnaire at 2 weeks

With the McGill Melzack Pain Questionnaire, the location of the pain, the emotion it creates in the individual, its relationship with time, its severity and the level of livable pain for the individual will be determined.

Extension endurance test change

时间窗: change from baseline extension endurance test change at 2 weeks

In the endurance evaluation of neck extensors, subjects will lie face down on the examination bed with their hands at their sides and their heads will be suspended from the bed until they are at chest level. The two-pound weight will hang just above ear level. With this weight, they will be asked to lift their heads back and not change this position until they get tired. The time they can hold the position will be recorded in seconds.

electrogoniometer change

时间窗: change from baseline electrogoniometer change at 2 weeks

The range of motion of the cervical region of the individuals participating in the study will be evaluated with an electrogoniometer. This device consists of six axes rotating potentiometers and seven connections. The end joints, which are considered fixed by the strapping system, are fixed at the level of the first thoracic vertebra. The other link is placed on the head with an adjustable helmet. This whole system is very light. It enables the monitoring of three-dimensional continuous and unrestricted neck movements relative to the thorax. The system measures flexion, extension, lateral flexion and rotation.

MyotonPRO device change

时间窗: change from baseline MyotonPRO device change at 2 weeks

The muscle tone of the individuals participating in the study will be evaluated with MyotonPRO. MyotonPRO is a portable device that measures muscle tone. It measures the mechanical impulses of the soft tissue with mechanical oscillations. A brief mechanical stimulus is applied to the skin over the muscle, followed by rapid relaxation. It measures the reflective resistance of the muscle to deformation of the applied force in Newtons/meter (N/m). The stiffness value is calculated as the ossification or maximum displacement of the tissue and the maximum acceleration. Larger values indicate a harder muscle. The muscle tone of the upper trapezius, sternocleidomastoid, and suboccipital muscles will be measured.

sociodemographic information change

时间窗: At baseline

The sociodemographic information, education level, existence of problems of the individuals participating in the study will be questioned and recorded.

visual analogue scale (VAS) change

时间窗: change from baseline the visual analogue scale at 2 weeks

In the evaluation made with VAS, patients will be asked to mark their pain intensity on a 10 cm horizontal line. Ranges for pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain

Flexion endurance test change

时间窗: change from baseline Flexion endurance test change at 2 weeks

The endurance of the cervical flexor muscles of the individuals participating in the study will be measured with the craniocervical flexion test using a stabilizer device. People lie on their back in a hooked position. Individuals will then be asked to bring their necks into the chin tuck position and feel the neck position. Subjects will be set to 20 mmHg in the stabilizer device and will be asked to increase these pressures by 2 mmHg until they reach 30 mmHg, stay at each pressure for 30 seconds, and complete the test by giving a 30-second rest period after each pressure. The test will be stopped when the individual is unable to complete the test, is in position, and feels excruciating pain.

次要结局

  • Headache Impact Scale (HIT-6) change(change from baseline Headache Impact Scale (HIT-6) at 2 weeks)
  • The Pittsburgh Sleep Quality Index (PSQI) change(change from baseline The Pittsburgh Sleep Quality Index (PSQI) at 2 weeks)
  • Corbin Posture Index change(change from baseline Corbin Posture Index at 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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