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临床试验/NCT03981809
NCT03981809已完成不适用

Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2019年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Conditioned pain modulation

研究概览

简要总结

Development and internal validation of an easy-to-use tool for clinical pain assessment. The tool has to be applicable in any clinical practice and without the need for expensive and complicated hospital tools to identify the source of persistent pain after the treatment of cancer.

详细描述

An adequate selection of physiotherapy treatment for persistent pain after the treatment of cancer, depends highly on the mechanism of the pain.

Pain can arise from a damaged nerve or tissue (skin, lymphatic system...). But when pain becomes chronic, alterations to the central nervous system can occur, as regulations of the facilitating and inhibiting mechanisms. These alterations may cause central sensitization pain. The body is now sensitized and cannot distinct harmful from harmless stimuli.

Each type of pain requires a specific treatment, therefore identification of the pain mechanism is crucial. Up till now, expensive and complex tests were performed in a hospital setting to determine if a patient suffers from neuropathic, nociceptive or central sensitization pain. This study aims for developping an assessment tool that does not require expensive devices but can be easily performed by any physiotherapist, within the timeframe of a standard consultation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient treated for primary cancer: breast, prostate, lung/bronchus, colon/rectum, gynecologic (uterus or ovary)
  • Complete remission
  • Curative treatment finished
  • Ongoing hormonal and targeted treatment permitted
  • Patient experiences pain (NRS minimum 3/10 during the past week)

排除标准

  • Active metastasis
  • Palliative status
  • Other type of cancer than mentioned in inclusion criteria
  • Pregnancy

结局指标

主要结局

Conditioned pain modulation

时间窗: 10 minutes

Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)

Temporal summation

时间窗: 2,5 minutes

Central sensitization pain: pain caused by changes in the central nervous system is assessed with a series of touch stimuli (3)

Diffuse pain

时间窗: 0,5 minute

Central sensitization pain: pain caused by changes in the central nervous system is assessed by painting affected areas on a body chart (4)

Joint pain

时间窗: 30 seconds

Nociceptive pain: pain that arises from a damaged tissue is assessed by examining if several joints are sore, especially in the morning (3)

Quantitative sensory testing

时间窗: 20 minutes

Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)

Manual palpation

时间窗: 3 minutes

Central sensitization pain: pain caused by changes in the central nervous system is assessed by applying pressure with manual palpation (5)

Douleur Neuropathic 4 questions (DN4) questionnaire

时间窗: 2 minutes

Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)

Lymphedema

时间窗: 4 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the presence of lymphedema by measuring the circumference of the arm (2)

Active mobility

时间窗: 2,5 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4)

Passive mobility

时间窗: 3,5 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the clinician can perform on the patient (5)

Strength

时间窗: 1,5 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by the strength the patient can perform in a specific movement (6)

Central Sensitization Inventory (CSI) questionnaire

时间窗: 5 minutes

Central sensitization pain: pain caused by changes in the central nervous system is assessed with a questionnaire (1)

Scar tissue

时间窗: 2 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the elasticity of the scar tissue by manual palpation of the clinician (7)

Pain mapping

时间窗: 1 minute

Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)

Evaluation of skin

时间窗: 20 seconds

Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)

Axillary web syndrome

时间窗: 2 minutes

Nociceptive pain: pain that arises from a damaged tissue is assessed by visually examining the presence of lymph cords in the axilla (8)

次要结局

  • Pain disability: Pain Disability Index(3 minutes)
  • Pain intensity: Visual Analogue Scale(1 minute)
  • Pain Self-efficacy and Expectations: questionnaire(5 minutes)
  • Pain catastrophizing scale(6 minutes)
  • Depression, anxiety and stress(7 minutes)
  • Pain character: questionnaire(4 minutes)
  • Pain questionnaire(30 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

An De Groef

Principal investigator An De Groef

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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