ArthritisThermRheumNCT04228458
ThermRheum Version 1
A study testing Thermal Imaging in people with Arthritis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Thermal Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2016to 25 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of:
- Poly-articular JIA
- Oligo-articular JIA
- Psoriatic JIA
- Enthesitis-related JIA
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Childrens NHS Foundation Trust
Sheffield, S10 2TH
About this study
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
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.
- Conditions
- Arthritis
- Being tested
- Thermal Imaging
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ImagingDevice
Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Imaging | Experimental | Thermal Imaging acquisition Receives: Device: Thermal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Thermal Imaging and changes in skin temperature
Correlation between Thermal Imaging and changes in skin temperature
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start9 Sep 2016
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228458
- Sponsor's protocol ID
- SCH-13-067d
- Acronym
- ThermRheum
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04228458
- Acronym / sponsor ID
- ThermRheum / SCH-13-067d
- Conditions
- Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermal Imaging | Experimental | Device: Thermal ImagingThermal Imaging acquisition |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Poly-articular JIA
- Oligo-articular JIA
- Psoriatic JIA
- Enthesitis-related JIA
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ImagingTesting the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis. | Device | Thermal Imaging |
Primary outcome
Correlation between Thermal Imaging and changes in skin temperature
Time frame: 30 minutes
Correlation between Thermal Imaging and changes in skin temperature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Imaging in people with Arthritis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Thermal Imaging and changes in skin temperature (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.