Characterizing Pain Sensitivity in Persistent Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- Experimental Pain Threshold
研究概览
简要总结
This research study will examine whether enhanced pain sensitivity increases the risk of persistent low back pain. The study will address the highly prevalent and costly condition of persistent low back pain and a major obstacle for the implementation of clinical strategies to improve patient outcomes. The knowledge gained from this study may lead to a better understanding of the biological mechanisms that contribute to persistent low back pain and will inform future work to develop predictive measures of persistent low back pain risk, evaluative measures to examine treatment efficacy, and possibly biomarker assay(s) to identify patients who are at increased risk of persistent low back pain.
详细描述
The specific aims (SA) of the proposed study are to:
Specific Aim 1. Characterize (A) the differences in pain sensitivity between incident cases and controls at low back pain onset and (B) changes in pain sensitivity over time in incident cases.
H1.A Incident cases will have increased pain sensitivity compared with controls at low back pain onset.
H1.B Incident cases will have increased pain sensitivity over time.
Specific Aim 2. Compare (A) genetic polymorphisms at low back pain onset between incident cases and controls and mRNA expression of candidate genes at LBP onset and at 6 weeks between incident cases and controls; and (B) differential expression levels of candidate genes over time in incident cases.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-50 years of age;
- •diagnosed with an acute episode of nonspecific LBP present for >24 hours but <4 weeks duration and preceded by at least 1 pain-free month; and
- •comprehend English
排除标准
- •<18 or >50 years of age;
- •chronic pain at another site or associated with a painful condition (eg., fibromyalgia, neuropathy, rheumatoid arthritis);
- •previous spinal surgery;
- •presence of neurological deficits;
- •history of comorbidities that affect sensorimotor function (eg., multiple sclerosis, spinal cord injury, diabetes); and
- •untreated psychological disorders (major depression, bipolar disorder, schizophrenia)
结局指标
主要结局
Experimental Pain Threshold
时间窗: 6 months
Quantitative sensory testing will be used to evaluate pain sensitivity over time
次要结局
- mRNA expression of pain sensitivity genes(6 months)