CClinicalTrials.gg
CompletedNCT03312348ThermlimpUpdated Jan 22, 2021Results posted

High Resolution IR Imaging for Diagnosis in the Acute Limping Child - ThermLimp

An interventional study of Infrared imaging in Limping, sponsored by Sheffield Children's NHS Foundation Trust. Completed. Open to participants aged 9 Months to 16 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Sheffield Children's NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
9 Months to 16 Years
Sex
All
01

Study summary

A variety of different diseases may cause a limp in a child, and in younger children it is particularly challenging to isolate the area affected. Children of this age group are unable to identify a specific region of pain, so clinical examination and parental interpretation is the only method of localising the area of discomfort. Potential problems that may affect children include inflammation, fractures, infection, juvenile arthritis or movement in the growth plate in the hip, among other diseases. Aside from an obvious source of injury, it is challenging for a clinician to distinguish between these different potential causes or the area of the problem without repeated visits, non-specific blood tests and the use of x-ray imaging: a form of radiation that carries with it a small risk of carcinogenic effect. Once a region of the lower limb is identified, an x-ray image of the affected area is often taken; however, it is not possible to image the entire leg, so the importance of the initial examination by a clinician is evident. The aim of this research project is to assess the potential of high resolution infrared (IR) imaging technology in the identification of a focus for the cause of a limping child. The IR camera used for imaging is able to observe an entire limb, so the need to localise an area for imaging would be removed. In addition, if successful, infrared imaging could reduce the number of children exposed to x-ray radiation unnecessarily, whilst stream-lining medical practice by reducing the time to make a diagnosis along with unnecessary visits and tests. The investigators aim to explore whether non-invasive IR thermographic camera imaging assists with the clinical diagnosis in children presenting with an acute limp. This study represents a pilot evaluation as a test of concept.

02

Conditions studied

  • Limping
03

Who can participate

Ages eligible
9 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children age 9 months -16 years old who attend the Emergency Department (ED) of the Sheffield Children's Hospital for an acute (less than 48 hours) limp. Inclusion is subject to both the patient and carer having read (or being read to in very young children) the information sheets and both the patient and carer consenting to participate.

Exclusion criteria

Exclusion Criteria:

  • Children with multiple injuries (e.g. those involved in serious car accidents), or those who have difficulty understanding the nature of the study (e.g. non-native English speakers, those with disabilities impairing their understanding of the study etc.) will be excluded. Patients/carers in whom consent has not been obtained or refused will also be excluded.

Children who attend the ED with safeguarding concerns or in whom child protection suspicions arise during the consultation will be excluded. These children have a separate assessment process which would be significantly different to the study cohort.

04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Infrared Imaging undertaken

    Infrared imaging of Region Of Interest in study participants

    Device: Infrared imaging

Interventions

  • DeviceInfrared imaging

    Infrared image image acquisition of study participants

05

What researchers measure

Primary outcomes

  1. Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child

    Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25

    Time frame: 10 minutes

06

Results

Posted Apr 24, 2019

Participant flow

Participant flow — Overall Study
MilestoneInfrared Imaging Undertaken
Started30
Completed30
Not completed0

Outcome measures

PrimaryNumber of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child

Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25

Time frame:
10 minutes
Reported as:
Count of participants · Participants
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child
ParticipantsInfrared Imaging Undertaken
Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child30

Adverse events

Collected over Adverse event data was requested for 6 months after recruitment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Infrared Imaging Undertaken0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Infrared Imaging Undertaken
<=18 years30
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Infrared Imaging Undertaken
Mean5.2 ± 3.0
Sex: Female, Male
Sex: Female, Male(Participants)Infrared Imaging Undertaken
Female10
Male20
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Infrared Imaging Undertaken
Region of Enrollment
Region of Enrollment(Participants)Infrared Imaging Undertaken
United Kingdom30
07

Study locations

No study locations are listed for this record.

08

Registry details

Key details

Study ID
NCT03312348
Lead sponsor
Sheffield Children's NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Jan 2016
Primary completion
Jun 2016
Completion
Jun 30, 2016
Results posted
Apr 24, 2019
Last update
Jan 22, 2021
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion