Evaluation of Pain, Cervical Mobility, Sleep Quality and Functional Status in Individuals with Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The Neck Disability Index
研究概览
简要总结
The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies.
The main questions it aims to answer are:
- How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
- What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 55 years.
- •Chronic neck pain (CNP) persisting for longer than 3 months (for the CNP group).
- •Volunteering participation in the study.
- •Healthy controls, including relatives of CNP participants.
排除标准
- •History of neck trauma or other cervical spine conditions (e.g., radiculopathy).
- •Prior surgical interventions involving the head, face, cervical spine, upper or lower extremities, or cervical disc herniation.
- •Degenerative spinal conditions.
- •Use of analgesics, anti-inflammatory medications, or muscle relaxants within the previous week.
- •Presence of rheumatological or cardiovascular diseases, chronic neurological or psychiatric disorders, substance abuse, anemia, or diabetes.
结局指标
主要结局
The Neck Disability Index
时间窗: Baseline
The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.
Pittsburgh Sleep Quality
时间窗: Baseline
Five questions on the scale are answered by the participant\'s partner or roommate and are used solely for clinical information..The PSQI has seven components: subjective sleep quality, sleep latency, total sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score is calculated by summing the scores of the seven components, ranging from 0 to 21 points.
Visual analog scale
时间窗: Baseline
A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.
Range of motion
时间窗: Baseline
Active Cervical Range of Motion Assessment was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). The same physiotherapist performed all goniometric measurements to eliminate any differences between the measurements that the measurer could cause. The American Association of Orthopaedic Surgeons (AAOS) values were taken as a reference for NEH in the cervical region. Care was taken to ensure that the participant wore comfortable clothes during the measurements. Before starting the measurement, the desired movement was shown to the participant by the physiotherapist.
次要结局
未报告次要终点
研究者
Gamze Demircioğlu
PhD, PT
Atlas University