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临床试验/NCT00021476
NCT00021476已完成3 期

Preventing Chronic Whiplash Pain: Biobehavioral Approach

University of Washington2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2001年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
2
主要终点
Mood

研究概览

简要总结

This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.

详细描述

More than 1.8 million people in the United States suffer from chronic pain and disability following motor vehicle accidents (MVAs) each year. The majority of these cases start with a relatively minor neck injury. The Quebec Task Force Study on Whiplash Associated Disorders (WAD) was created in 1989 to determine the clinical, public health, social, and financial determinants of WAD. Multiple studies have described the clinical features of WAD, which include neck, shoulder, arm, low back, and head pain; tinnitus; visual symptoms; dizziness; temporomandibular joint pain; and paraesthesias. Onset of these symptoms after the injury is usually delayed for several hours and worsens within 24 to 48 hours. Neck pain is the most frequent symptom, and between 14% and 42% of patients with WAD develop chronic neck pain symptoms. Studies suggest that the neck pain will either resolve in the first few months or persist indefinitely. One variable that may predict outcome after an MVA is the acute emotional response immediately after the MVA.

A severe emotional reaction accompanied by neck pain and stiffness after an MVA could lead an injured person to avoid subsequent physical activity through such mechanisms as fear avoidance and fear of reinjury. Research investigating the evolution of chronic pain due to musculoskeletal injury suggests that initial emotional reactivity, particularly fear of reinjury and subsequent activity avoidance, contributes significantly to unremitting pain and persistent disability. Research based on this model has shown that early interventions targeting normalization of excessive emotionality and restriction of activities associated with fear following injury effectively prevent chronic pain due to back injury. No previous study has sought to intervene during the first three months after an MVA with a behavioral and physical exercise program to encourage activity and discourage continued fear of movement, pain and disability.

This study consists of two primary components: (1) To compare the effectiveness of two anxiety-reduction treatments with standard care in reducing pain and activity limitations in patients with WADs 2 to 3 months following MVAs. (2) To test whether psychological responses to the initial trauma, such as fear avoidance, fear of injury, and negative affectivity, discriminate between symptomatic WAD patients and WAD sufferers whose symptoms had resolved 2 to 3 months post-MVA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single

入排标准

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

入选标准

  • Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks

排除标准

  • 未提供

结局指标

主要结局

Mood

时间窗: Measured 3 months after the accident

Pain

时间窗: Measured 3 months after the accident

Functional activity

时间窗: Measured 3 months after the accident

次要结局

  • Physical symptoms(Measured 3 months after the accident)
  • Range of motion/strength(Measured 3 months after the accident)
  • Fear avoidance(Measured 3 months after the accident)

研究者

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

Dennis Turk

Study Principal Investigator

University of Washington

研究点 (2)

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