Prediction of Persistent Post-Mastectomy Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Persistent mastectomy pain
研究概览
简要总结
Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies indicate that individual differences in pain sensitivity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. Using these data, a prediction model for PPMP will be developed, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy.
详细描述
This study is a prospective observational study which phenotypes individuals' baseline pain, psychosocial and psychophysical characteristics, then measures perioperative and long-term changes to examine the relationship of psychophysical and psychosocial processing to persistent post-mastectomy pain development .
Preoperative Psychophysical assessment:
Pressure pain testing methods: After giving informed consent, the PI or a fully trained member of the research staff will administer a brief QST session. Pressure pain threshold and tolerance will be assessed using a digital pressure algometer (Wagner FDX, Greenwich, CT, USA) with a flat round transducer, probe area 0.785 cm2. Testing sites will be bilateral on the dorsal aspect of the proximal forearm (extremity site) and over the trapezius muscle at the upper back (truncal site). For pressure threshold determination, pressure is increased at a steady rate of approximately 1 kg/second until subject indicates that the pressure is first perceived as painful. Pressure pain tolerance will be determined by instructing patients to indicate the pressure at which the pain was no longer tolerable. Two trials will be performed at each site.
Temporal Summation testing methods: Mechanical pinprick pain will be assessed using standardized weighted pinprick applicators similar to those described by Rolke et al99 of two designated forces (256mN and 512mN) which result in a painful sensation in most subjects.1-2,100 First, a single stimulation of the lower force pinprick will be applied to the dorsal aspect of the index finger between the first and second interphalangeal joints of the each hand while resting palm down on the armrest, and then rated by the subject on a scale of 0-10. Next, after a break of at least 10 seconds, a train of 10 stimuli will be applied at the same premarked spot, at a rate of 1 stimulation/second. The subject will rate pain on a scale of 0-10 after the first, fifth and tenth stimulus, then rate any ongoing pain 15 and 30 seconds after cessation of the last stimulus. The same procedure will be repeated using the higher force pinprick on the third finger of the each hand. Subjects will undergo two trials at each force, with a break of at least one minute between trials.
Psychosocial Assessment: Preoperative demographic, medical, psychosocial and pain questionnaires will be completed by the patient during their preoperative office visit. Questionnaires assessing psychosocial factors are chosen based upon previous association with PPMP, strong psychometric validation characteristics, and brevity. The Pain Catastrophizing Scale (PCS), which has been validated in pain patients and controls, will be used to measure catastrophic thinking associated with pain. Depressive symptoms, anxiety and sleep disturbance will be assessed using short-form instruments from the NIH roadmap initiative, Patient Reported Outcome Measurement Information System (PROMIS), which have been extensively validated in studies comparing results with established scales, and have been calibrated on over 20,000 persons. The Brief Symptom Index 18-Somatization Scale, also previously validated in chronic pain patients,107 will be used to measure somatization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Persistent mastectomy pain
时间窗: 1 year
based the breast cancer pain questionnaire, which assesses multiple related body areas, severity and frequency of pain
次要结局
未报告次要终点
研究者
Kristin Schreiber
Faculty, Department of Anesthesiology
Brigham and Women's Hospital
