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临床试验/NCT03958149
NCT03958149已完成不适用

Comparison of Measurements of the Cervical Spine in Adults With and Without Immobilisation

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Measurements of Angulation of the Neck (C-spine) on MRI Scans

研究概览

简要总结

This is a prospective study aiming to assess the shape of the neck in adults. In addition the study will look at the shape of the neck in a spinal collar and the comfort while wearing a spinal collar.

详细描述

The investigators aim to compare baseline scans of the neck in those aged 18yrs and older to a second neck scan where the participant is wearing a spinal collar. Experts will analyse the scans for measurements of angulations. In addition the study will collect demographic data and results from a validated patient questionnaire assessing comfort wearing the spinal collar.

The hypothesis:

  1. The shape of the neck is different when comparing the young and old populations
  2. The spinal collar does not alter the shape of the spine
  3. The spinal collars are uncomfortable in the elderly population

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Persons aged 18yrs and over to those aged 30yrs
  • •Persons aged 70yrs and over
  • •Ability to give informed consent to participate in the study

排除标准

  • •Persons under 18yrs of age and those aged 31yrs -69yrs
  • •Persons who lack capacity to consent for entry into the study
  • •Persons who are unable to complete the visual analogue score or questionnaire due to co-existent visual and hearing loss. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
  • •Persons unable to understand the information leaflet in English.
  • •Those with current neck pain, known previous C-spine injury or known medical condition affecting the spine.
  • •Persons who do not pass the safety questionnaire to undergo an MRI scan
  • •Persons who are unable to tolerate an MRI scan due to claustrophobia
  • •Persons who are unable to transfer to the scanner table independently
  • •Persons unable to lie flat and still for 10 minutes
  • •Persons who do not give consent to their General Practitioner being informed of scan results.

研究组 & 干预措施

Spinal collar

Other

Participants will undergo MRI scans in and out a spinal collar to assess whether the measurements of angulation of the C-spine change whilst wearing a spinal collar.

干预措施: spinal collar (Device)

结局指标

主要结局

Measurements of Angulation of the Neck (C-spine) on MRI Scans

时间窗: Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.

Comparison of the measurements of angulation of the neck (assessed on MRI imaging) in the young person compared to the older person. Statistical analysis to allow comparison of groups.

次要结局

  • The Degree of Change in Measurements of Angulation of the Neck (C-spine) on MRI Scans Whilst Wearing a Spinal Collar Compared to When Not Wearing a Spinal Collar.(Baseline MRI image, approximately 30 minutes and second MRI image (with collar on), after one hour of wearing collar.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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