NCT04228458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

January 8, 2020

Last Update Submit

January 13, 2020

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

  • Correlation between Thermal Imaging and changes in skin temperature

    Correlation between Thermal Imaging and changes in skin temperature

    30 minutes

Study Arms (1)

Thermal Imaging

EXPERIMENTAL

Thermal Imaging acquisition

Device: Thermal Imaging

Interventions

Thermal ImagingDEVICE

Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.

Thermal Imaging

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Childrens NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 14, 2020

Study Start

September 9, 2016

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)