Openness to Cognitive Approach of Nonspecific Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.
Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.
排除标准
- •Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
- •Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
研究组 & 干预措施
Chronic Pain and the Brain
This condition is a 15 to 20-minute exercise that patients complete in which they examine variables in themselves that suggest that their pain is driven by central nervous system processes / their brains.
干预措施: Pain neuroscience education patient exercise (Behavioral)
Health Behavior Control
This 15 to 20-minute exercise is designed as a control condition that has face validity as helpful and that relates to health. Thus, patients are asked to examine various domains of their own health behavior as engaged in over the past 24 hours (e.g., nutrition, sleep, exercise, hygiene, social connections).
干预措施: Health behavior control intervention (Behavioral)
结局指标
主要结局
Brief Pain Inventory
时间窗: Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Self-reported pain and dysfunction
次要结局
- Patient-Reported Outcomes Measurement Information System: Depression short form 8b(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Pain attributions questionnaires(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Tampa Scale for Kinesiophobia(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Patient-Reported Outcomes Measurement Information System: Anger short form 5a(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Satisfaction with Life Scale(Change from baseline to 1-month follow-up (with secondary 10-month follow-up))
- Pain Stages of Change Questionnaire(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
- Pain Catastrophizing Scale(Change from baseline to 1-Month follow-up (with secondary 10-month follow-up))
研究者
Mark A. Lumley
Distinguished Professor of Psychology
Wayne State University