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临床试验/NCT04228458
NCT04228458已完成不适用

Does Thermal Imaging Correlate With Musculoskeletal Examination in the Identification of Inflamed Joints in Children and Young People With Juvenile Idiopathic Arthritis? A Prospective Diagnostic Accuracy Study

Sheffield Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月9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
20
试验地点
2
主要终点
Correlation between Thermal Imaging and changes in skin temperature

研究概览

简要总结

Childhood arthritis is a diagnosis made by clinicians based upon their clinical examination, during which patients are assessed for signs of swelling, warmth and restricted movement of the joints using the sensation of touch. Clinicians use investigations such as blood tests and scans which may be costly, associated with waiting times, can cause the patient stress or anxiety. Patients with childhood arthritis can often present with flares of their condition even when on medical treatment, which may require further investigations to determine the nature of the problem. Studies in adult Rheumatology have demonstrated that a thermal imaging camera (which detects heat given off by the body) can be useful in assessing for signs of inflammation in arthritis. The use of this camera could provide an alternative to the tests described; it does not require any contact with the patient, is quick and easy to use, and does not emit any radiation. The investigators hope that this pilot study will demonstrate that thermal imaging can be used to complement the standardised assessments of joint inflammation as done routinely in clinic and may lead to further work comparing thermal imaging with other tests such as MRI scanning and ultra-sound.

The investigators will recruit 20-50 children with arthritis affecting either knee or ankle joints. The investigators will use a highly sensitive thermal imaging camera to take pictures and short video recordings of each ankle and knee joint, recording skin temperature and colour. The investigators will compare this with the clinicians' assessment of whether the knee and ankle joints are inflamed or not. The investigators are interested in finding out whether the information recorded using the camera mirrors the assessment made by the clinician.

研究设计

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

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of:
  • Poly-articular JIA
  • Oligo-articular JIA
  • Psoriatic JIA
  • Enthesitis-related JIA

排除标准

  • CYP below 4 years of age (pGALS is validated for school-age children and patients will be required to remain still during TI process)
  • Ongoing active/chronic infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days of recruitment, or oral antibiotics within 14 days of recruitment
  • History of active tuberculosis of less than 6 months treatment or untreated latent tuberculosis
  • Soft tissue infection, injury or fracture of the affected joint which could confound the TI signature
  • Presence of any inflammatory skin condition (including, but not limited to Eczema and Psoriasis) which may be in close proximity to or overlying the joint
  • Presence of any other diagnosis which could cause arthritis including systemic-JIA (associated systemic inflammation may affect skin temperature independently of arthritis) or undifferentiated-JIA (excluded to ensure homogeneity of the sample investigated)
  • Non-English speaking patients and/or parent(s)/guardian(s)
  • Non-consenting CYP, or parent(s)/guardian(s)

结局指标

主要结局

Correlation between Thermal Imaging and changes in skin temperature

时间窗: 30 minutes

Correlation between Thermal Imaging and changes in skin temperature

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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