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临床试验/NCT04330573
NCT04330573已完成不适用

Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification

Universidad San Jorge1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Neck Disability Index Change

研究概览

简要总结

Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as the presence of temporal summation (TS) and pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that PPTs are significantly lower compared to healthy subjects and the association between PPTs, pain intensity and disability are inconsistent. Further, there are psychosocial factors (catastrophizing, kinesiophobia, stress...) that may influence the pain experience. This psychosocial factors associated with chronic pain are not systematically collected in the QST literature complicating the interpretation of data. The objectives of this study are 1) to determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia, catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations between disability, psychosocial and sensory factors and 3) to observe if there is a homogeneity between the subjects.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Presence of red flag as reported in the medical history (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis);
  • Neck pain with cervical radiculopathy;
  • fibromyalgia syndrome,
  • previous neck surgery;
  • currently undergoing any type of pain treatment or having received physical therapy in the previous 3 months.

结局指标

主要结局

Neck Disability Index Change

时间窗: T0 (baseline); T1 (1 month); T2 (6 months).

It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache. The 10 item scores are then summed to yield a global NDI score, which has a range of 0-50 where higher values reflect greater neck disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for neck disability indicate improvement

Quick-DASH change

时间窗: T0 (baseline); T1 (1 month); T2 (6 months).

The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The QuickDASH is a widely used reference of self reported disability. The 11 item scores are then summed to yield a global QuickDASH score, which has a range of 11-100 where higher values reflect greater shoulder/arm disability. 1 and 6-month results were subtracted from baseline. As such, positive change scores for shoulder/arm disability indicate improvement

次要结局

  • Pain Intensity change- Visual Analogic Scale(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Catastrophism change. Pain Catastrophizing Scale(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Pain Duration change(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Area of pain assessed by bodycharts change(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Pressure Pain Threshold change(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Temporal Summation change(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Stress change. Perceived Stress Scale(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Quality of Sleep change . Pittsburgh Questionnaire(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Anxiety-Depression change. DASS 21.(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Kinesiophobia change. Tampa Scale for Kinesiophobia(T0 (baseline); T1 (1 month); T2 (6 months).)
  • Quality of Life change. The 5-level EQ-5D version (EQ-5D-5L)(T0 (baseline); T1 (1 month); T2 (6 months).)

研究者

发起方
Universidad San Jorge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Herrero Gallego

Dr. Pablo Herrero, PT, PhD

Universidad San Jorge

研究点 (1)

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