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临床试验/NCT01431261
NCT01431261已完成不适用

Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)

研究概览

简要总结

The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.

详细描述

Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life.

Physical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain.

Thus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach.

The study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic neck pain for at least 6 months
  • reduced physical neck function (NDI minimum 10)
  • pain primarily in the neck region,
  • finished any medical /radiological examinations
  • able to read and understand Danish and
  • able to participate in the exercise program.

排除标准

  • radiculopathies upper extremity
  • neurological deficits
  • in a process of examining for unknown pathology,
  • experimental medical treatment,
  • being in a unstable social situation
  • pregnancy
  • fractures
  • suffering from depression
  • other known coexisting medical conditions which would severely restrict participation in the exercise program

结局指标

主要结局

Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)

时间窗: 12 months

次要结局

  • TAMPA scale of Kinesiophobia(12 months)
  • Euroqol-5D(12 months)
  • Pain Specific Functioning Scale(4 months and 12 months)
  • Mechanical allodynia(12 months)
  • Self-rated measure Global Perceived Effect(12 months)
  • Pain Bothersomeness(12 months)
  • craniocervical flexion test(12 months)
  • cervical range of motion(12 months)
  • Impact of Event scale(12 months)
  • neck positioning test(12 months)
  • Neck Disability Index(12 months)

研究者

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

Inge Ris Hansen

PhD. student

University of Southern Denmark

研究点 (2)

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