跳至主要内容
临床试验/NCT04888026
NCT04888026已完成不适用

Impact on Pain Sensitivity of Clinical Interaction

Spine Centre of Southern Denmark6 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年5月10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
87
试验地点
6
主要终点
The Conditioned pain modulation effect [changes in kPa]

研究概览

简要总结

Pain can currently be quantified using quantitative sensory tests (QSTs). However, we lack knowledge concerning how relational and contextual factors impact these quantitative tests. We will examine how a standard QST battery is affected by "removing" the social and human interaction from the test session compared to usual QST testing where the participant is guided through the assessment by a research assistant.

Our objectives are:

  1. How is the QST affected when guided by a research assistant compared to guided by a computer
  2. Does the level of the assessor's empathy affect the QST outcome
  3. How do psychological factors affect the QST testing
  4. are these outcomes affected by the patient profile (low back pain patients vs healthy controls)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

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

  • Primary complaint of low back pain
  • No pain for healthy controls
  • No serious psychological or somatic disorders potentially interfering with the QST

排除标准

  • Incomplete QST data

结局指标

主要结局

The Conditioned pain modulation effect [changes in kPa]

时间窗: Baseline

Between-group differences in conditioned pain modulation (CPM). The CPM \[range -1000;1000 kPa\] is measured as the change between a pressure pain threshold test before and after a cold pressor test (2 minutes of immersion the left hand in ice water\].

次要结局

  • Pressure pain threshold(Baseline)

研究者

发起方
Spine Centre of Southern Denmark
申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验