Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients: Implications for a Personalized Treatment Approach
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Pain intensity at 1 month as assessed by NRS
研究概览
简要总结
This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.
详细描述
Chronic low back pain (CLBP) is a very prevalent condition, associated with high disability and financial costs. Pain sensitization and psychological status have been associated with symptom severity and treatment outcomes, but their prognostic value is not yet well established.
This is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.
This work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •persistent or recurrent low back pain lasting over 3 months
排除标准
- •pain due to other causes (e.g. fibromyalgia, fracture)
- •back surgery in the previous 6 months or planned in the following 6 months
- •debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)
- •disability compensation or litigation related to CLBP
- •unavailability to commit to the hypnosis sessions.
结局指标
主要结局
Pain intensity at 1 month as assessed by NRS
时间窗: 1 month post-intervention
Pain intensity assessed by NRS
Pain intensity at 3 months as assessed by NRS
时间窗: 3 months post-intervention
Pain intensity assessed by NRS
Pain intensity at 6 months as assessed by NRS
时间窗: 6 months post-intervention
Pain intensity assessed by NRS
Pain intensity at 1 week as assessed by Numeric Rating Scale (NRS)
时间窗: 1 week post-intervention
Pain intensity assessed by NRS
次要结局
- Optimism at 1 month as assessed by LOT(1 month post-intervention)
- Functionality at 1 month as assessed by the ODI(1 month post-intervention)
- Functionality at 6 months as assessed by the ODI(6 months post-intervention)
- Pain interference at 6 months as assessed by the BPI(6 months post-intervention)
- Functionality at 1 week as assessed by the Oswestry Low Back Pain Disability Questionnaire (ODI)(1 week post-intervention)
- Functionality at 3 months as assessed by the ODI(3 months post-intervention)
- Quality of life at 3 months as assessed by the EQ-5D-5L(3 months post-intervention)
- Emotional distress at 6 months as assessed by the Hospital Anxiety and Depression Scale (HADS)(6 months post-intervention)
- Optimism at 3 months as assessed by LOT(3 months post-intervention)
- Pain catastrophizing at 1 week as assessed by the Pain Catastrophizing Scale (PCS)(1 week post-intervention)
- Pain catastrophizing at 1 month as assessed by PCS(1 month post-intervention)
- Pain interference at 1 week as assessed by the Brief Pain Inventory (BPI)(1 week post-intervention)
- Quality of life at 1 week as assessed by the EuroQol Quality of Life Questionnaire (EQ-5D-5L)(1 week post-intervention)
- Quality of life at 6 months as assessed by the EQ-5D-5L(6 months post-intervention)
- Optimism at 1 week as assessed by the Life Orientation Test (LOT)(1 week post-intervention)
- Optimism at 6 months as assessed by LOT(6 months post-intervention)
- Pain interference at 1 month as assessed by the BPI(1 month post-intervention)
- Pain interference at 3 months as assessed by the BPI(3 months post-intervention)
- Emotional distress at 1 week as assessed by the Hospital Anxiety and Depression Scale (HADS)(1 week post-intervention)
- Emotional distress at 1 month as assessed by the Hospital Anxiety and Depression Scale (HADS)(1 month post-intervention)
- Emotional distress at 3 months as assessed by the Hospital Anxiety and Depression Scale (HADS)(3 months post-intervention)
- Quality of life at 1 month as assessed by the EQ-5D-5L(1 month post-intervention)
- Pain catastrophizing at 6 months as assessed by PCS(6 months post-intervention)
- Pain catastrophizing at 3 months as assessed by PCS(3 months post-intervention)
研究者
Patrícia Ribeiro Pinto
Researcher
University of Minho