Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients
2019年5月9日 更新者：Kristian Kjær Petersen、Aalborg University
The purpose of the project is to associate pre-treatment pain sensitivity level, levels of pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back Screening Tool in patients with acute low back pain and patients' progression after 12 weeks of treatment by general practitioners.
研究概览
研究类型
观察性的
注册 (实际的)
58
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aalborg East
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Aalborg、Aalborg East、丹麦、9220
- Lægerne Sløjfen
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
概率样本
研究人群
The subjects will be recruited through general practitioners in The North Denmark Region.
When a patient with low back pain reports to his/her general practitioner, the doctor will present the project to the patient, and in case the patient shows interest, the doctor asks him/her to contact the contact person of the study.
Thus, the recruitment does not take place through advertisements, but through the normal patient flow in the general practice.
描述
Inclusion Criteria:
- Patients with low back pain, who have a mobile phone.
Exclusion Criteria:
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Alcohol addiction
- Lack of ability to cooperate
- Surgery to the spine
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Roland Morris Disability Questionnaire, RMDQ
大体时间：12 weeks follow-up
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Change in the Roland-Morris Questionnaire (RMDQ) is one of the most widely used questionnaires for back pain.
The RMDQ is a self-administered disability questionnaire consisting of 24 questions.
The questions are related specifically to physical functions likely to be affected by low back pain.
Each item is qualified with the phrase "because of my back pain" to distinguish back pain disability from disability due to other causes.
When completing the RMDQ, the respondents are asked to tick a statement if it applies to them on that particular day.
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12 weeks follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The StarT Back Screening Tool
大体时间：Baseline, 12 weeks follow-up
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The The StarT Back Screening Tool (SBST) is a nine-item patient self-reporting questionnaire validated for triage of nonspecific low back pain patients in primary care.
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Baseline, 12 weeks follow-up
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The Pain Catastrophizing Scale
大体时间：Baseline, 12 weeks follow-up
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The Pain Catastrophizing Scale (PCS) consists of 13 items focusing on thoughts and feelings in connection with pain.
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Baseline, 12 weeks follow-up
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Predicting the Inception of Chronic Pain
大体时间：Baseline, 12 weeks follow-up
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The Predicting the Inception of Chronic Pain (PICKUP) questionnaire focuses on pain ("How much low back pain have you had during the past week?", 1 = none, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe, 6 = very severe), radiating pain to the legs ("Do you have leg pain?" 0 = no, 1 = yes), compensability ("Is your back pain compensable, e.g. through worker's compensation or third party insurance?"
0 = no, 1 = yes), depression ("How much have you been bothered by feeling depressed in the past week (0-10 scale)?" 0 = not at all, 10 = extremely) and the subject's overall evaluation of the risk of chronic pain ("In your view, how large is the risk that your current pain may become persistent (0-10 scale)?" 0 = none, 10 = extreme).
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Baseline, 12 weeks follow-up
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Basic information
大体时间：Baseline, 12 weeks follow-up
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A general questionnaire has been created for this study to gain a basic understanding of the patient's current pain, demographic information and use of medication
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Baseline, 12 weeks follow-up
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Assessment of the Pain Area
大体时间：Baseline, 12 weeks follow-up
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Patients will be asked to draw the pain area of their low back pain on a body map.
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Baseline, 12 weeks follow-up
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Cuff Algometry
大体时间：Baseline, 12 weeks follow-up
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Cuff algometry will be applied to assess pressure pain thresholds, temporal summation of pain and conditioned pain modulation.
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Baseline, 12 weeks follow-up
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Handheld Algometry
大体时间：Baseline, 12 weeks follow-up
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Handheld algometry will be applied to assess pressure pain thresholds.
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Baseline, 12 weeks follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Martin B Jensen, MD, PhD、Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月3日
初级完成 (实际的)
2018年11月6日
研究完成 (实际的)
2018年11月6日
研究注册日期
首次提交
2017年3月31日
首先提交符合 QC 标准的
2017年4月11日
首次发布 (实际的)
2017年4月12日
研究记录更新
最后更新发布 (实际的)
2019年5月10日
上次提交的符合 QC 标准的更新
2019年5月9日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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