Pain Phenotyping of Patients With Bone Cancer Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Conditioned pain modulation (CPM) determined by cuff pressure algometry
研究概览
简要总结
The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.
详细描述
Cancer patients in palliative care point to pain as their most important and most feared symptom. Bone metastases are a common cause of cancer pain, and the patients are prone to transient severe pain exacerbations (breakthrough pain), which can occur spontaneously or be triggered by movement. Patients with bone metastases experience pain of such high intensity, that it affects not only physical activity, but also sleep, mood and social relations. This results in poor quality of life for the patients and poses an increasing clinical and socio-economical problem. The pain is difficult to treat and often requires high opioid doses which results in unacceptable adverse effects, and there is an unmet need of novel therapeutic options and treatment strategies.
Animal models of cancer-induced bone pain have suggested that pain arising from metastatic bone disease involve neuropathic and nociceptive pain mechanisms and, importantly, mechanisms that are specific to cancer-induced bone pain. Significant neuronal sprouting can occur at the metastatic site, and the inherent pain control system is found altered in animal models of cancer-induced bone pain; a system that can be exploited for treatment strategies and in the development of new analgesia. Yet, it is not known how the pre-clinical findings translate to patients.
Quantitative sensory testing is a psychophysical method that uses a battery of sensory stimuli with predetermined physical properties, thus allowing the capture and quantification of stimulus-evoked negative and positive sensory phenomena in humans. Conditioned pain modulation is a psychophysical experimental measure of the endogenous pain inhibitory pathway in humans, which can be used to detect an impairment of the descending inhibitory pain pathway.
This study aims to perform pain phenotyping of patients suffering from cancer-induced bone pain, through pain specific questionnaires, quantitative sensory testing and conditioned pain modulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary breast cancer
- •Bone metastases
- •Competent
排除标准
- •Not fluent in spoken Danish
- •Chemotherapy or radiation within the last 3 months
- •Other chronic pain disease that may affect the quantitative sensory testing or conditioned pain modulation
- •Alcohol or medicine abuse
- •Pregnancy
结局指标
主要结局
Conditioned pain modulation (CPM) determined by cuff pressure algometry
时间窗: 1 day
CPM will be determined by placing two inflatable cuffs around the lower legs; one providing a test stimulus and the other a conditioning stimulus. First, the pressure pain detection and tolerance thresholds (kPa) are determined on each lower leg using an increasing pressure of 1 kPa/s; next a constant conditioning stimulus is applied to the dominant lower leg and 10 seconds later the pain pressure detection and tolerance threshold (kPa) are simultaneously determined on the non-dominant leg. The CPM effect is assessed as the percent difference between the measured thresholds on the non-dominant lower leg.
Sensory mapping with thermorollers and brush
时间窗: 1 day
Sensory changes to cold, warm and dynamic mechanical stimulation with thermo rollers (25°C and 40°C) and a standardized brush (No. 5, Somedic). Determination of area with either increased, decreased or painful changes.
次要结局
- Mechanical pain threshold with PinPrick.(1 day)
- Wind up ratio with Pin Prick(1 day)
- Cuff pressure pain threshold and pressure pain tolerance determined by cuff pressure algometry(1 day)
- Temporal summation of pressure pain(1 day)
- Questionnaire - The Short Form Brief Pain Inventory(1 day)
- Questionnaire - PainDETECT(1 day)
- Questionnaire - The Breakthrough Pain Questionnaire(1 day)
- Questionnaire - Pain Catastrophizing Scale(1 day)
研究者
Anne-Marie Heegaard
Associate Professor
University of Copenhagen
