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ThermRheum Version 1 (ThermRheum)

Primary Purpose

Arthritis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermal Imaging
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arthritis

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sheffield Childrens NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermal Imaging

Arm Description

Thermal Imaging acquisition

Outcomes

Primary Outcome Measures

Correlation between Thermal Imaging and changes in skin temperature
Correlation between Thermal Imaging and changes in skin temperature

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
January 13, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04228458
Brief Title
ThermRheum Version 1
Acronym
ThermRheum
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermal Imaging
Arm Type
Experimental
Arm Description
Thermal Imaging acquisition
Intervention Type
Device
Intervention Name(s)
Thermal Imaging
Intervention Description
Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.
Primary Outcome Measure Information:
Title
Correlation between Thermal Imaging and changes in skin temperature
Description
Correlation between Thermal Imaging and changes in skin temperature
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Sheffield Childrens NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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ThermRheum Version 1

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