ThermRheum Version 1 (ThermRheum)

January 13, 2020 updated by: Sheffield Children's NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sheffield, United Kingdom, S10 2TH
        • Sheffield Childrens NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of:

  • Poly-articular JIA
  • Oligo-articular JIA
  • Psoriatic JIA
  • Enthesitis-related JIA

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermal Imaging
Thermal Imaging acquisition
Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Thermal Imaging and changes in skin temperature
Time Frame: 30 minutes
Correlation between Thermal Imaging and changes in skin temperature
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2016

Primary Completion (Actual)

June 25, 2018

Study Completion (Actual)

June 25, 2018

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-13-067d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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