跳至主要内容
临床试验/NCT07116590
NCT07116590已完成不适用

Investigation of Cervical Spinal Stability, Proprioception, and Body Awareness in Individuals With Migraine

Hacettepe University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Migraine Disability Assessment Questionnaire-MIDAS

研究概览

简要总结

The aim of this study is to compare cervical spinal stability, cervical proprioception, and body awareness in individuals with migraine and healthy controls, and to examine the relationship between these parameters.

Hypotheses of the Study:

H1: Cervical spinal stability differs between individuals with migraine and healthy individuals.

H2: Cervical proprioception differs between individuals with migraine and healthy individuals.

H3: Body awareness differs between individuals with migraine and healthy individuals.

H4: There is a relationship between cervical spinal stability, cervical proprioception, and body awareness in individuals with migraine.

详细描述

After collecting demographic and disease-related data from individuals with migraine, and demographic data from healthy controls, the following assessments will be conducted: Migraine Disability Assessment Questionnaire (MIDAS), Bournemouth Neck Questionnaire, Fremantle Neck Awareness Questionnaire, Body Awareness Questionnaire, Body Awareness Rating Questionnaire, cervical spinal stability, and cervical proprioception.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Have been diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD-III) criteria,
  • Are in the interictal period,
  • Are between 18 and 55 years of age, and
  • Agree to participate in the study
  • Age- and sex-matched healthy individuals

排除标准

  • Individuals with other types of headache,
  • Those with a history of neck or head trauma,
  • Individuals with cervical disc herniation or cervical arthrosis,
  • Those with any other systemic or neurological medical condition (e.g., chronic pain syndrome, rheumatoid arthritis, systemic lupus erythematosus, stroke, trigeminal neuralgia, etc.),
  • Pregnant individuals,
  • Patients who have received anesthetic blockade within the past 6 months.

结局指标

主要结局

Migraine Disability Assessment Questionnaire-MIDAS

时间窗: up to 3 months

It is a questionnaire consisting of five questions related to disability over the past three months. Individuals score the number of days lost due to headache in three domains: schoolwork, paid work, and household activities. Additionally, they report the number of extra days with significant activity limitations (defined as at least a 50% reduction in productivity) in paid and household work. The MIDAS score is calculated by summing the scores of these five items.

Bournemouth Neck Questionnaire:

时间窗: up to 3 months

This questionnaire consists of seven items, each scored on a scale from 0 to 10. It evaluates the impact of pain on daily activities, pain severity, levels of anxiety and depression, kinesiophobia, and the ability to cope with pain.

Fremantle Neck Awareness Questionnaire

时间窗: up to 3 months

This questionnaire consists of nine items, each scored on a scale from 0 to 4. It assesses awareness of the cervical region. Higher scores indicate poorer body awareness.

Body Awareness Questionnaire

时间窗: up to 3 months

This questionnaire consists of 18 items, each scored on a scale from 1 to 7, and is used to assess body awareness. Higher scores indicate better body awareness.

Body Awareness Rating Questionnaire

时间窗: up to 3 months

This questionnaire consists of 24 items divided into four domains: function, mood, sensation/emotion, and awareness. Each item scores a 7-point Likert type scale. Each factor's scores range between 6 to 42 and higher scores indicates higher body awareness

Cervical Spine Stability

时间窗: up to 3 months

The craniocervical flexion test will be performed using a pressure biofeedback unit (Stabilizer, Chattanooga, Australia). The test consists of five stages. During the test, participants will lie in a supine position with the head and neck in neutral alignment, and the device will be placed under the suboccipital region. In the initial stage, the pressure will be set at 20 mmHg, and participants will be instructed to perform a craniocervical flexion movement. Subsequently, the test will proceed through five incremental stages, increasing the pressure in 2 mmHg increments from the initial 20 mmHg up to a maximum of 30 mmHg. At each pressure level, participants will be asked to maintain the movement for 10 repetitions of 10 seconds each. Based on these stages, the Activation Score and Performance Index will be calculated

Cervical Proprioception

时间窗: up to 3 months

Joint position error test will be conducted using a laser pointer attached to the participant's head. While sitting on a chair with back support, participants will face a wall where a target will be placed 90 cm away. Participants will first be asked to sense the starting position (the center of the target). Then, with their eyes closed, they will be instructed to return their head to the starting position from various directions (flexion, extension, and rotation). The deviation from the target center will be measured in centimeters, and the test will be repeated three times. The average of the three trials will be used as the final score.

次要结局

未报告次要终点

研究者

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

Güngör Beyza ÖZVAR

Principal Investigator

Hacettepe University

研究点 (1)

Loading locations...

相似试验