Locating Nociceptive Stimuli Applied to the Lumbar Region in Healthy Subjects and in Subjects With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The distance from marked points to the representation of the stimulated point on the digital body chart.
研究概览
简要总结
Digital body charts are used to assess the pain experience in people with pain. People are asked to report their pain by shading a human body template on a digital tablet. The aim of this study is to investigate whether people with chronic low back pain, compared to healthy volunteers, consistently locate on a digital body chart all nociceptive stimuli induced in the lumbar region.
详细描述
Healthy volunteers and people presenting chronic low back pain, will be recruited. A standardized grid will be drawn over the participants' lumbar region. Circular electrodes, connected to a constant current stimulator, will be applied at points on the grid. All participants will be blinded to the electrode locations. Painful electrocutaneous stimuli will be randomly delivered for each electrode. Participants will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.
The body chart will be centred on a canvas 768x1024 pixels (pxl), and pain location will be defined by X and Y coordinates. The consistency in reporting the location of each painful stimulation will be described through coordinates.
In addition, only people presenting chronic low back pain will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Every participant will recive stimulation on his back in a pre-defined random order.
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
- •Chronic low back pain (duration more than three months)
排除标准
- •denial of informed consent;
- •presence of pacemaker;
- •pregnancy or possible pregnancy status;
- •lumbar surgery (spinal fusion);
- •documented degenerative pathology of the central nervous system;
- •documented concomitant pathology altering sensitivity (e.g. diabetes, fibromyalgia);
- •reduced motor control of the dominant hand (reported by every subject as conditioning the writing and therefore the ability to compile the body chart);
- •presence of skin moles and/or scars on the back that may interfere with the conduction of the electrical stimulus.
结局指标
主要结局
The distance from marked points to the representation of the stimulated point on the digital body chart.
时间窗: Immediately after the electrocutaneous stimulation
次要结局
- Oswestry Disability Index (ODI) score(Before electrocutaneous stimulation)
- Current pain level on Visual Analogue Scale (VAS, 0-10 cm)(Before electrocutaneous stimulation)
- Recent pain (last week) level on Visual Analogue Scale (VAS, 0-10 cm)(Before electrocutaneous stimulation)
- Tampa Scale for Kinesiophobia (TSK-13)(Before electrocutaneous stimulation)
- The Short Form Health Survey (SF-36)(Before electrocutaneous stimulation)
研究者
Alessandra Raschi
Principal Investigator
IRCCS San Raffaele