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临床试验/NCT04219072
NCT04219072已完成不适用

Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Central Sensitization Inventory

研究概览

简要总结

Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.

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

入选标准

  • diagnosed with histologically confirmed invasive or non-invasive primary breast cancer
  • completed remission and their primary treatment at least 3 months prior to study participation
  • experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale

排除标准

  • patients affected by other chronic disease,
  • severe psychological disorders
  • active metastases

结局指标

主要结局

Central Sensitization Inventory

时间窗: 10 minute

The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100. A score of 40 or higher on the CSI means the presence of nociplastic pain.

Short Form 36

时间窗: 10 minute

The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire. SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.

Numeric Pain Rating Scale

时间窗: 1 minute

The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Margolis Pain Diagram

时间窗: 5 minute

The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours

次要结局

  • Quantitative sensory test(10 minute)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Saracoglu

Principal Investigator

Kutahya Health Sciences University

研究点 (1)

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