Thermography - Medical Clinical Policy Bulletins | Aetna

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Thermography

Last Review 03/10/2020

Effective: 07/21/1995

Next Review: 01/14/2021

Review History

Definitions

Additional Information

Clinical Policy Bulletin Notes

Number: 0029

Policy *Please see amendment forPennsylvaniaMedicaid

at the end of this CPB.

Aetna considers thermography (including digital infrared thermal imaging, magnetic

resonance (MR) thermography and temperature gradient studies) experimental and

investigational for all indications including the following (not an all-inclusive list) because

available medical literature indicates thermography to be an ineffective diagnostic

technique:

Assessment o f myofascial trigger points

Detection and screening for breast cancer

Detection of rupture-prone vulnerable coronary plaque

Determination of t he efficacy of str oke rehabilitation

Diagnosis of complex regional pain syndrome

Diagnosis of musculoskeletal injuries

Diagnosis and management of va sculitis

Diagnosis of temporomandibular disorders

Early identification of skin neoplasms

Esophageal monitoring

Evaluation of acute skin toxicity of breast radiotherapy

Evaluation of burn wounds

Evaluation of dry eye disease

Evaluation of leprosy

Evaluation and monitoring of individuals with Emery-Dreifuss muscular

dystrophy

Joint assessment in individuals with inflammatory arthritis

Management o f infantile hemangioma

Monitoring of diabetes mellitus

Pre- and peri-operative management of hidradenitis suppurativa

Prediction and detection of pressure ulcers

Prognosis of post-herpetic neuralgia

Screening for adolescent idiopathic scoliosis.

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Aetna considers dynamic infrared blood perfusion imaging (DIRI) for intra-operative and

post-operative perfusion assessment (e.g., assessment of skin blood perfusion in

cranioplasty and flap evaluation) experimental and investigational because of insufficient

evidence regarding its clinical effectiveness.

See also CPB 0028 - Temporomandibular Disorders (0028.html).

Thermography

Thermography is the measurement of temperature variations at the body surface. The

scientific evidence suggests that thermography may only confirm the presence of a

temperature difference, and that other procedures are needed to reach a specific

diagnosis. Thermography may add little to what doctors already know based on history,

physical examination, and other studies.

Thermography studies are non-invasive imaging techniques that are intended to

measure the skin surface temperature distribution of various organs and tissues. The

infrared radiation from the tissues reveals temperature variations by producing brightly

colored patterns on a liquid crystal display. Interpretation of the color pattern is thought

to contribute to the diagnosis of many disorders including breast cancer, Raynaud's

phenomenon, digital artery vasospasm, impaired spermatogenesis in infertile men, deep

vein thrombosis, reflex sympathetic dystrophy/complex regional pain syndrome,

vertebral subluxation, and others.

In contrast to the skin surface thermography techniques used by some chiropractors and

other providers, a newer invasive test called a temperature gradient study involves an

intravenous catheter. The catheter is threaded into the coronary arteries to directly

measure temperature differences on the inner artery walls. Researchers believe this

information may be related to the presence of unstable coronary artery plaques and

could be useful in diagnosing vulnerable patients. Madjid et al (2006) have shown that

inflamed atherosclerotic plaques are hot and their surface temperature correlates with

an increased number of macrophages and decreased fibrous-cap thickness. Multiple

animal and human experiments have shown that temperature heterogeneity correlates

with arterial inflammation in vivo. Several coronary temperature mapping catheters are

currently being developed and studied. These thermography methods can be used in

the future to detect vulnerable plaques, potentially to determine patients' prognosis, and

to study the plaque-stabilizing effects of different medications.

A number of medical authorities have concluded that thermography has no proven

medical value, including the American Medical Association, the Office of Health

Technology Assessment (OHTA), and the American Academy of Neurology. Based on a

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study by the OHTA, the Health Care Financing Administration (now the Center for

Medicare and Medicaid Services) withdrew Medicare coverage of thermography.

Devices that have been used for thermography skin temperature differential analysis

include the Nervoscope, the Temp-O-Scope, and the Neurocalometer.

There is insufficient evidence for the use of thermography for detection of breast cancer.

A structured evidence review of thermography for breast cancer (Kerr, 2004) reached

the following conclusions: "The evidence that is currently available does not provide

enough support for the role of infrared thermography for either population screening or

adjuvant diagnostic testing of breast cancer. The major gaps in knowledge at this time

can only be addressed by large-scale, prospective randomised trials. More robust

research on the effectiveness and costs of technologically advanced infrared

thermography devices for population screening and diagnostic testing of breast cancer is

needed, and the conclusions of this review should be revisited in the face of additional

reliable evidence".

Other reviews have also found a need for additional research on thermography.

Kennedy et al (2009) noted that thermography was first introduced as a screening tool

for breast cancer in mid-1950s. However, after a 1977 study found thermography to lag

behind other screening tools, the medical community lost interest in this diagnostic

approach. These researchers discussed each screening tool with a focus brought to

thermography. They stated that no single diagnostic tool provides excellent

predictability; however, a combination that incorporates thermography may boost both

sensitivity as well as specificity. The authors concluded that in light of technological

advances and maturation of the thermographical industry, more research is needed to

confirm the potential of thermography in providing an effective non-invasive, low-risk

adjunctive tool for the early detection of breast cancer.

Mammography is currently the gold standard for breast cancer screening. Thus,

sensitivities, specificities, as well as positive and negative predictive values of

thermography need to be compared with those of mammography in order to ascertain if

thermography is equivalent or superior to mammography. Presently, there is a lack of

scientific data comparing the 2 screening techniques. In addition, there are no published

evidence-based practice guidelines and/or position statements that recommend

thermography as the appropriate method of screening for early detection of breast

cancer.

Arora et al (2008) examined the effectiveness of a non-invasive digital infrared thermal

imaging (DITI) system in the detection of breast cancer. A total of 92 patients for whom

a breast biopsy was recommended based on prior mammogram or ultrasound

underwent DITI. Three scores were generated: (i) an overall risk score in the

screening mode, (ii) a clinical score based on patient information, and (iii)

assessment by artificial neural network. Sixty of 94 biopsies were malignant and 34

were benign. Digital infrared thermal imaging identified 58 of 60 malignancies, with 97

% sensitivity, 44 % specificity, and 82 % negative predictive value depending on the

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mode used. Compared to an overall risk score of 0, a score of 3 or greater was

significantly more likely to be associated with malignancy (30 % versus 90 %, p < 0.03).

The author concluded that DITI is a valuable adjunct to mammography and ultrasound,

especially in women with dense breast parenchyma. Moreover, the authors reported a

high negative predictive value for thermography where "the location of the lesion under

question based on prior imaging was assessed to generate a positive or negative clinical

assessment", i.e., where they were unblinded to the results of the prior mammography

or ultrasound. The specificity was only 11 % and the negative predictive value of

thermography was only 66 % in the blinded screening mode. Furthermore, the authors

stated that DITI is not currently recommended or approved as a substitute for screening

mammography, and correlation of findings on DITI should be made with alternative

imaging techniques. They stated that further studies are needed using a representative

screening population of persons who have not been selected for biopsy based upon

prior imaging results.

An American Cancer Society report Mammograms and Other Breast Imaging

Procedures (2010) stated that "[t]hermography is a way to measure and map the heat

on the surface of the breast using a special heat-sensing camera. It is based on the

idea that the temperature rises in areas with increased blood flow and metabolism,

which could be a sign of a tumor. Thermography has been around for many years, and

some scientists are still trying to improve the technology to use it in breast imaging. But

no study has ever shown that it is an effective screening tool for finding breast cancer

early. It should not be used as a substitute for mammograms. Newer versions of this

test are better able to find very small temperature differences. They may prove to be

more accurate than older versions, and are now being studied to find out if they might be

useful in finding cancer". Thermography is listed under "newer and experimental breast

imaging methods" in this report.

Additionally, the United Kingdom's NHS Cancer Screening Programmes (2010) stated

that "thermography is not a replacement for mammography. It is a relatively new test

and isn't reliable enough to use either to diagnose or screen for cancer. Mammography

is still the best test and is used as a world wide standard for breast screening in women

over 50".

The Food and Drug Administration (FDA, 2011) stated that breast thermography should

not be used instead of mammography, noting that thermography has not been approved

as a stand-alone tool for breast cancer screening or diagnosis. Telethermographic

devices produce infrared images and do not require exposure to radiation or breast

compression, which some healthcare providers claim make them superior to

mammographic devices. However, the FDA stated that "there is simply no evidence"

that breast thermography can take the place of mammography. The agency has sent

warning letters to manufacturers and practitioners who have made misleading claims

about breast thermography use.

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Currently, there is insufficient evidence to support the use of thermography for the

diagnosis of complex regional pain syndrome (CRPS). The use of thermography in the

diagnosis of CRPS type 1 (CRPS1) is based on the presence of temperature

asymmetries between the involved area of the extremity and the corresponding area of

the uninvolved extremity. However, the interpretation of thermographical images is

subjective and not validated for routine use. Huygen et al (2004) developed a sensitive,

specific and reproducible arithmetical model as the result of computer-assisted infra-red

thermography in patients with early stage CRPS1 in one hand. Eighteen patients with

CRPS1 on one hand and 13 healthy volunteers were included in the study. The severity

of the disease was determined by means of pain questionnaires [visual analogue scale

(VAS) pain and McGill Pain Questionnaire], measurements of mobility (active range of

motion) and edema volume. Asymmetry between the involved and the uninvolved

extremities was calculated by means of the asymmetry factor, the ratio and the average

temperature differences. The discrimination power of the 3 methods was determined by

the receiver-operating curve (ROC). The regression between the determined

temperature distributions of both extremities was plotted. Subsequently the correlation

of the data was calculated. In normal healthy individuals the asymmetry factor was 0.91

(0.01) (SD), whereas in CRPS1 patients this factor was 0.45 (0.07) (SD). The

performance of the arithmetic model based on the ROC curve was excellent. The area

under the curve was 0.97 (p < 0.001), the sensitivity and specificity was 9 2% and 94 %,

respectively. Furthermore, the temperature asymmetry factor was correlated with the

duration of the disease and VAS pain.

Gradl and colleagues (2003) stated that CRPS1 represents a frequent complication

following distal radial fractures. These investigators studied the value of clinical

evaluation, radiography and thermography in the early diagnosis of CRPS1. A total of

158 patients with distal radial fractures were followed-up for 16 weeks after trauma.

Apart from a detailed clinical examination 8 and 16 weeks after trauma, thermography

and bilateral radiographs of both hands were carried out. At the end of the observation

period 18 patients (11 %) were clinically identified as CRPS1. The severity of the

preceding trauma and the chosen therapy did not influence the process of the disease.

Sixteen weeks after trauma easy differentiation between normal fracture patients and

CRPS1 patients was possible. Eight weeks after distal radial fracture clinical evaluation

showed a sensitivity of 78 % and a specificity of 94 %. On the other hand,

thermography (58 %) and bilateral radiography (33 %) revealed poor sensitivities. The

specificity was high for radiography (91 %) and again poor for thermography (66 %).

These authors concluded that the results of the study support the importance of clinical

evaluation in the early diagnosis of CRPS1. Plain radiographs facilitate the diagnosis as

soon as bony changes develop.

Arterial wall thermography has also been used to identify rupture-prone vulnerable

coronary plaque. However, the clinical value of arterial thermography in interventional

cardiology has not been established.

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Schaar and colleagues (2007) noted that rupture of vulnerable plaques is the principal

cause of acute coronary syndrome and myocardial infarction. Identification of vulnerable

plaques is therefore essential to enable the development of treatment modalities to

stabilize such plaques. Thermography is one of the several novel methods being

examined for detecting vulnerable plaques. It evaluates the temperature heterogeneity

as an indicator of the metabolic state of the plaque. The authors concluded that while

several invasive and non-invasive techniques are currently under development to

assess vulnerable plaques, none has proven its value in an extensive in-vivo validation

and all have a lack of prospective data.

García-García and colleagues (2008) stated that thin-capped fibroatheroma is the

morphology that most resembles plaque rupture. Detection of these vulnerable plaques

in-vivo is essential to being able to study their natural history and evaluate potential

treatment modalities and, therefore, may ultimately have an important impact on the

prevention of acute myocardial infarction and death. The investigators reported that,

currently, conventional grayscale intra-vascular ultrasound, virtual histology and

palpography data are being collected with the same catheter during the same pullback.

A combination of this catheter with either thermography capability or additional imaging,

such as optical coherence tomography or spectroscopy, would be an exciting

development. Intra-vascular magnetic resonance imaging also holds much promise.

The investigators stated that, to date, none of the techniques described above has been

sufficiently validated and, most importantly, their predictive value for adverse cardiac

events remains elusive. The investigators concluded that very rigorous and well-

designed studies are needed for defining the role of each diagnostic modality. Until

researchers are able to detect in-vivo vulnerable plaques accurately, no specific

treatment is warranted.

Madjid and colleagues (2006) stated that up to 2/3 of acute myocardial infarctions

develop at sites of culprit lesions without a significant stenosis. New imaging techniques

are needed to identify those lesions with an increased risk of developing an acute

complication in the near future. Inflammation is a hallmark feature of these

vulnerable/high-risk plaques. These investigators have demonstrated that inflamed

atherosclerotic plaques are hot and their surface temperature correlates with an

increased number of macrophages and reduced fibrous-cap thickness. They noted that

animal and human studies have reported that temperature heterogeneity correlates with

arterial inflammation in-vivo. Several coronary temperature mapping catheters are

currently being developed. These thermographic methods can be used in the future to

detect vulnerable plaques, potentially to ascertain patients' prognosis, and to examine

the plaque-stabilizing effects of various pharmacotherapies.

Sharif and Murphy (2010) noted that critical coronary stenoses have been shown to

contribute to only a minority of acute coronary syndromes and sudden cardiac death.

Autopsy studies have identified a subgroup of high-risk patients with disrupted

vulnerable plaque and modest stenosis. Consequently, a clinical need exists to develop

methods to identify these plaques prospectively before disruption and clinical expression

of disease. Recent advances in invasive as well as non-invasive imaging techniques

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have shown the potential to identify these high-risk plaques. The anatomical

characteristics of the vulnerable plaque such as thin cap fibro-atheroma and lipid pool

can be identified with angioscopy, high frequency intra-vascular ultrasound, intra-

vascular magnetic resonance imaging (MRI), and optical coherence tomography. Efforts

have also been made to recognize active inflammation in high-risk plaques using intra-

vascular thermography. Plaque chemical composition by measuring electro-magnetic

radiation using spectroscopy is also an emerging technology to detect vulnerable

plaques. Non-invasive imaging with MRI, computed tomography, and positron emission

tomography also holds the potential to differentiate between low-risk and high-risk

plaques. However, at present none of these imaging modalities is able to detect

vulnerable plaque nor have they been shown to definitively predict outcome.

Nevertheless in contrast, there has been a parallel development in the physiological

assessment of advanced athero-sclerotic coronary artery disease. Thus, recent trials

using fractional flow reserve in patients with modest non flow-limiting stenoses have

shown that deferral of percutaneous coronary intervention with optimal medical therapy

in these patients is superior to coronary intervention. The authors concluded that further

trials are needed to provide more information regarding the natural history of high-risk

but non flow-limiting plaque to establish patient-specific targeted therapy and to refine

plaque stabilizing strategies in the future.

There is insufficient evidence to support the use of thermography in post-herpetic

neuralgia. Han and associates (2010) examined the usefulness of infrared

thermography as a predictor of post-herpetic neuralgia (PHN). Infrared thermography

was performed on the affected body regions of 110 patients who had been diagnosed

with acute herpes zoster (HZ). Demographical data collected included age, gender, time

of skin lesions onset, development of PHN, and co-morbidities. The temperature

differences between the unaffected and affected dermatome were calculated.

Differences greater than 0.6 degrees C for the mean temperature across the face and

trunk were considered abnormal. The affected side was warmer in 35 patients and

cooler in 33 patients than the contralateral side. A patient's age and disease duration

affected treatment outcomes. However, the temperature differences were not correlated

with pain severity, disease duration, allodynia, development of PHN, and use of anti-viral

agents (p > 0.05). The authors concluded that a patient's age and disease duration are

the most important factors predicting PHN progression, irrespective of thermal findings,

and PHN can not be predicted by infrared thermal imaging.

An Agency for Healthcare Research and Quality's report on non-invasive diagnostic

techniques for the detection of skin cancers (Parsons et al, 2011) listed thermography as

one of the investigational diagnostic techniques for the detection of skin cancers.

Kontos et al (2011) determined the sensitivity and specificity of DITI in a series of

women who underwent surgical excision or core biopsy of benign and malignant breast

lesions presenting through the symptomatic clinic. Digital infrared thermal imaging was

evaluated in 63 symptomatic patients attending a 1-stop diagnostic breast clinic.

Thermography had 90 true-negative, 16 false-positive, 15 false-negative and 5 true-

positive results. The sensitivity was 25 %, specificity 85 %, positive-predictive value 24

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%, and negative-predictive value 86 %. The authors concluded that despite being non-

invasive and painless, because of the low sensitivity for breast cancer, DITI is not

indicated for the primary evaluation of symptomatic patients nor should it be used on a

routine basis as a screening test for breast cancer.

The Canadian Agency for Drugs and Technologies in Health’s technology assessment

on Infrared thermography for population screening and diagnostic testing for breast

cancer” (Morrison, 2012) states that “No randomized controlled trials have been

conducted that compare the effectiveness of thermography with mammography for

screening in well women, and there is no evidence regarding the cost-effectiveness of

thermography used for screening. Prospective cohort studies of symptomatic patients or

patients with abnormal mammograms or ultrasounds do not provide the type of evidence

needed to justify the use of thermography for breast screening. Results indicate that

thermography performance is worse than mammography in terms of sensitivity,

specificity, and predictive values; however, some of the studies’ authors have suggested

there may be a role for thermography as an adjunct diagnostic test in some cases”.

Kim et al (2012) evaluated the accuracy of the size and location of the ablation zone

produced by volumetric MRI-guided high-intensity focused ultrasound (HIFU) ablation of

uterine fibroids on the basis of MR thermometric analysis and assessed the effects of a

feedback control technique. A total of 33 women with 38 uterine fibroids were treated

with an MR imaging-guided HIFU system capable of volumetric feedback ablation. Size

(diameter times length) and location (3-D displacements) of each ablation zone induced

by 527 sonications (with [n = 471] and without [n = 56] feedback) were analyzed

according to the thermal dose obtained with MR thermometry. Prospectively defined

acceptance ranges of targeting accuracy were ± 5 mm in left-right (LR) and cranio-

caudal (CC) directions and ± 12 mm in antero-posterior (AP) direction. Effects of

feedback control in 8- and 12-mm treatment cells were evaluated by using a mixed

model with repeated observations within patients. Overall mean sizes of ablation zones

produced by 4-, 8-, 12-, and 16-mm treatment cells (with and without feedback) were 4.6

mm ± 1.4 (standard deviation) × 4.4 mm ± 4.8 (n = 13), 8.9 mm ± 1.9 × 20.2 mm ± 6.5 (n

= 248), 13.0 mm ± 1.2 × 29.1 mm ± 5.6 (n = 234), and 18.1 mm ± 1.4 × 38.2 mm ± 7.6

(n = 32), respectively. Targeting accuracy values (displacements in absolute values)

were 0.9 mm ± 0.7, 1.2 mm ± 0.9, and 2.8 mm ± 2.2 in LR, CC, and AP directions,

respectively. Of 527 sonications, 99.8 % (526 of 527) were within acceptance ranges.

Feedback control had no statistically significant effect on targeting accuracy or ablation

zone size. However, variations in ablation zone size were smaller in the feedback

control group. The authors concluded that sonication accuracy of volumetric MRI-

guided HIFU ablation of uterine fibroids appears clinically acceptable and may be further

improved by feedback control to produce more consistent ablation zones.

Brkljacic et al (2013) noted that breast cancer is a common malignancy causing high

mortality in women especially in developed countries. Due to the contribution of

mammographic screening and improvements in therapy, the mortality rate from breast

cancer has decreased considerably. An imaging-based early detection of breast cancer

improves the treatment outcome. Mammography is generally established not only as

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diagnostic but also as screening tool, while breast ultrasound plays a major role in the

diagnostic setting in distinguishing solid lesions from cysts and in guiding tissue

sampling. Several indications are established for contrast-enhanced MRI.

Thermography was not validated as a screening tool and the only study performed long

ago for evaluating this technology in the screening setting demonstrated very poor

results. The conclusion that thermography might be feasible for screening cannot be

derived from studies with small sample size, unclear selection of patients, and in which

mammography and thermography were not blindly compared as screening modalities.

Thermography cannot be used to aspirate, biopsy or localize lesions pre-operatively

since no method so far was described to accurately transpose the thermographic

location of the lesion to the mammogram or ultrasound and to surgical specimen. The

authors concluded that thermography cannot be proclaimed as a screening method,

without any evidence whatsoever.

The Work Loss Data Institute’s guideline on “Low back -- lumbar & thoracic (acute &

chronic)” (2013) listed thermography (infrared stress thermography) as one of the

interventions/procedures that was considered, but is not recommended.

Sanchis-Sanchez et al (2014) noted that musculoskeletal injuries occur frequently.

Diagnostic tests using ionizing radiation can lead to problems for patients, and infra-red

thermal imaging could be useful when diagnosing these injuries. A systematic review

was performed to determine the diagnostic accuracy of infra-red thermal imaging in

patients with musculoskeletal injuries. A meta-analysis of 3 studies evaluating stress

fractures was performed and found a lack of support for the usefulness of infra-red

thermal imaging (including thermography) in musculoskeletal injuries diagnosis.

Dibai-Filho and Guirro (2015) reviewed recent studies published on the use of infra-red

thermography (IRT) for the assessment of myofascial trigger points (MTrPs). A search

of the MEDLINE, CINAHL, PEDro, and SciELO databases was carried out between

November 2012 and January 2013 for articles published in English, Portuguese, or

Spanish from the year 2000 to 2012. Because of the nature of the included studies and

the purpose of this review, the analysis of methodological quality was assessed using

the Quality Assessment of Diagnostic Accuracy Studies tool. The search retrieved 11

articles, 2 of which were excluded based on language (German and Chinese); 3 were

duplicated in different databases, 1 did not use IRT for diagnostic purposes, and the

other did not use IRT to measure the skin temperature. Thus, the final sample was

made up of 4 observational investigations: 3 comparative studies and 1 accuracy study.

The authors concluded that at present, there are few studies evaluating the accuracy

and reliability of IRT for the diagnosis and assessment of MTrPs. Of the few studies

present, there is no agreement on skin temperature patterns in the presence of MTrPs.

Burke-smith et al (2015) states that currently the only evidence-based adjunct to clinical

evaluation of burn depth is laser Doppler imaging (LDI), although preliminary studies of

alternative imaging modalities with instant image acquisition are promising. These

researchers investigated the accuracy of IRT and spectrophotometric intracutaneous

analysis (SIA) for burn depth assessment, and compared this to the current gold

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standard: LDI. They included a comparison of the 3 modalities in terms of cost,

reliability and usability. These investigators recruited 20 patients with burns presenting

to the Chelsea and Westminster Adult Burns Service. Between 48 hours and 5 days

after burn, these researchers recorded imaging using (i) moorLDI2-BI-VR (LDI), (ii) FLIR

E60 (IRT) and (iii) Scanoskin (SIA). Subsequent clinical management and outcomewas

as normal, and not affected by the extra images taken. A total of 24 burn regions were

grouped according to burn wound healing: group A healed within 14 days, group B

within 14 to 21 days, and group C took more than 21 days or underwent grafting. Both

LDI and IRT accurately determined healing potential in groups A and C, but failed to

distinguish between groups B and C (p > 0.05). Scanoskin interpretation of SIA was 100

% consistent with clinical outcome. The authors concluded that FLIR E60 and

Scanoskin both presented advantages to moorLDI2-BI-VR in terms of cost, ease-of-use

and acceptability to patients. Infra-red thermography is unlikely to challenge LDI as the

gold standard as it is subject to the systematic bias of evaporative cooling. At present,

the LDI color-coded palette is the easiest method for image interpretation, whereas

Scanoskin monochrome color-palettes are more difficult to interpret. However the

additional analyses of pigment available using SIA may help more accurately indicate

the depth of burn compared with perfusion alone. The authors suggested development

of Scanoskin software to include a simplified color-palette similar to LDI and additional

work to further investigate the potential of SIA as an alternative to the current gold

standard.

Evaluation of Burn Wounds

Prindeze and associates (2015) noted that despite advances in perfusion imaging, burn

wound imaging technology continues to lag behind that of other fields. Quantification of

blood flow is able to predict time for healing, but clear assessment of burn depth is still

questionable. Active dynamic thermography (ADT) is a non-contact imaging modality

capable of distinguishing tissue of different thermal conductivities. Utilizing the abnormal

heat transfer properties of the burn zones, these researchers examined if ADT was

useful in the determination of burn depth in a model of early burn wound evaluation.

Duroc pigs (castrated male; n = 3) were anesthetized, and 2 burns were created with an

aluminum billet at 3 and 12 seconds. These contact times resulted in superficial partial

and deep partial thickness burn wounds, respectively. Active dynamic thermography

and laser Doppler imaging (LDI) imaging were performed every 30 minutes post-burn for

a total of 5 imaging sessions ending 150 minutes post-burn. For ADT, imaging excitation

was performed for 42 to 120 seconds with dual quartz-infrared lamps, and subsequent

infrared image capture was performed for 300 seconds; MATLAB-assisted image

analysis was performed to determine burn zone region of interest thermal relaxation and

characteristic patterns. Laser Doppler imaging was performed with a moorLDI system,

and biopsies were captured for histology following the 150-minute imaging session.

Both ADT and LDI imaging modalities were able to detect different physical properties at

30, 60, 90, 120, and 150 minutes post-burn with statistical significance (p < 0.05).

Resultant ADT cooling curves characterized greater differences with greater stimulation

and a potentially more identifiable differential cooling characteristic. Histological

analysis confirmed burn depth. The authors concluded that this preliminary work

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confirmed that ADT can measure burn depth and is deserving of further research either

as a stand-alone imaging technology or in combination with a device to assess

perfusion.

Burke-Smith and colleagues (2015) stated that the only evidence-based adjunct to

clinical evaluation of burn depth is LDI, although preliminary studies of alternative

imaging modalities with instant image acquisition are promising. These investigators

examined the accuracy of IRT and spectrophotometric intracutaneous analysis (SIA) for

burn depth assessment, and compared this to the current gold standard: LDI. They

included a comparison of the 3 modalities in terms of cost, reliability and usability.

These investigators recruited 20 patients with burns presenting to the Chelsea and

Westminster Adult Burns Service. Between 48 hours and 5 days post-burn, these

researchers recorded imaging using moorLDI2-BI-VR (LDI), FLIR E60 (IRT) and

Scanoskin (SIA). Subsequent clinical management and outcome was as normal, and

not affected by the extra images taken. A total of 24 burn regions were grouped

according to burn wound healing: group A healed within 14 days, group B within 14 to 21

days, and group C took more than 21 days or underwent grafting. Both LDI and IRT

accurately determined healing potential in groups A and C, but failed to distinguish

between groups B and C (p > 0.05). Scanoskin interpretation of SIA was 100 %

consistent with clinical outcome. The authors concluded that FLIR E60 and Scanoskin

both presented advantages to moorLDI2-BI-VR in terms of cost, ease-of-use and

acceptability to patients. Infrared thermography is unlikely to challenge LDI as the gold

standard as it is subject to the systematic bias of evaporative cooling. At present, the

LDI color-coded palette is the easiest method for image interpretation, whereas

Scanoskin monochrome color-palettes are more difficult to interpret. However the

additional analyses of pigment available using SIA may help more accurately indicate

the depth of burn compared with perfusion alone. The authors suggested development

of Scanoskin software to include a simplified color-palette similar to LDI, and additional

work to further investigate the potential of SIA as an alternative to the current gold

standard.

Jaspers and colleagues (2019) noted that reliable and valid assessment of burn wound

depth or healing potential is essential to treatment decision-making, to provide a

prognosis, and to compare studies evaluating different treatment modalities. These

researchers compared and summarized the quality of relevant measurement properties

of techniques that aim to assess burn wound depth or healing potential. They carried

out a systematic literature search using PubMed, Embase and Cochrane Library. Two

reviewers independently evaluated the methodological quality of included articles using

an adapted version of the Consensus-based Standards for the selection of health

Measurement INstruments (COSMIN) checklist. A synthesis of evidence was performed

to rate the measurement properties for each technique and to draw an overall

conclusion on quality of the techniques. A total of 36 articles were included, evaluating

various techniques, classified as laser Doppler techniques; thermography or thermal

imaging; other measurement techniques. Strong evidence was found for adequate

construct validity of laser Doppler imaging (LDI). Moderate evidence was found for

adequate construct validity of thermography, videomicroscopy, and spatial frequency

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domain imaging (SFDI). Only 2 studies reported on the measurement property

reliability. Furthermore, considerable variation was observed among comparator

instruments. The authors concluded that considering the evidence available, it

appeared that LDI is currently the most favorable technique; thereby assessing burn

wound healing potential. These researchers stated that additional research is needed

into thermography, videomicroscopy, and SFDI to evaluate their full potential; future

studies should focus on reliability and measurement error, and provide a precise

description of which construct is aimed to measure.

Evaluation of Dry Eye Disease

Tan and colleagues (2016) evaluated the effectiveness of IR ocular thermography in

screening for dry eye disease (DED); IR ocular thermography was performed on 62 dry

eye and 63 age- and sex-matched control subjects. Marking of ocular surface and

temperature acquisition was done using a novel “diamond” demarcation method. A total

of 30 static- and 30 dynamic-metrics were studied and receiver operating characteristic

curves were plotted. Effectiveness of the temperature metrics in detecting DED were

evaluated singly and in combination in terms of their area under the curve (AUC),

Youden's index and discrimination power (DP). Absolute temperature of the extreme

nasal conjunctiva 5s and 10s after eye opening were best detectors for DED. With

threshold value for the first metric set at 34.7° C, sensitivity and specificity was 87.1 %

(95 % CI: 76.2 to 94.3 %) and 50.8 % (95 % CI: 37.9 to 63.6 %), respectively. With

threshold value for the second metric set at 34.5°C, sensitivity and specificity was 77.6

% (95 % CI: 64.7 to 87.5 %) and 61.9 % (95 % CI: 48.8 to 73.9 %), respectively. The 2

metrics had moderate accuracy and limited performances with AUC of 72 % (95 % CI:

63 to 81 %) and 73 % (95 % CI: 64 to 82 %); Youden index of about 0.4 and DP of 1.07

and 1.05, respectively. None of the dynamic metrics was good detector for DED.

Combining metrics was not able to increase the AUC. The authors concluded that the

findings of this study suggested some utility for the application of IR ocular

thermography for evaluation of patients with DED.

Evaluation of Leprosy

Cavalheiro and associates (2016) examined if IRT would be able to measure the change

in temperature in the hands of people with leprosy. The study assessed 17 leprosy

patients who were under treatment at the National Reference Center for Sanitary

Dermatology and Leprosy, and 15 people without leprosy for the control group. The

infrared camera FLIR A325 and Therma CAM Researcher Professional 2.9 software

were used to measure the temperature. The room was air-conditioned, maintaining the

temperature at 25° C; the distance between the camera and the limb was 70 cm. The

vasomotor reflex of patients was tested by a cold stress on the palm. The study showed

a significant interaction between the clinical form of leprosy and temperature, where the

control group and the borderline-borderline form revealed a higher initial temperature,

while borderline-lepromatous and lepromatous leprosy showed a lower temperature.

Regarding vasomotor reflex, lepromatous leprosy patients were unable to recover the

initial temperature after cold stress, while those with the borderline-tuberculoid form not

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only recovered but exceeded the initial temperature. The authors concluded that IRT

proved a potential tool to assist in the early detection of neuropathies, helping in the

prevention of major nerve damage and the installation of deformities and disabilities that

are characteristic of leprosy.

Management of Infantile Hemangioma

In a preliminary, prospective, observational study, Burkes et al (2016) applied a

functional imaging method, dynamic IRT, to investigate infantile hemangiomas (IH)

status versus control skin and over time. A total of 25 subjects with superficial or mixed

IHs (age of less than 19 months) over 59 clinic visits were included in this study.

Infrared images of IHs and control sites, standardized color images, and three-

dimensional (3D) images were obtained. Tissue responses following application and

removal of a cold stress were recorded with video IRT. Outcomes included areas under

the curve during cooling (AUCcool ) and rewarming (AUCrw ) and thermal intensity

distribution maps. AUCcool and AUCrw were significantly higher and cooling rate

slower for IHs versus uninvolved tissue indicating greater heat, presumably due to

greater perfusion and metabolism for the IH. Infra-red distribution maps showed specific

areas of high and low temperature. Significant changes in IH thermal activity were

reflected in the difference (AUCcool - AUCrw ), with 6.2 at 2.2 months increasing to 37.6

at 12.8 months; IH cooling rate increased with age, indicating slower recovery, and

interpreted as reduced proliferation and/or involution. The authors concluded that

dynamic IRT was a well-tolerated, quantitative functional imaging modality appropriate

for the clinic, particularly when structural changes, i.e., height, volume, color, were not

readily observed. They stated that dynamic IRT may aid in monitoring progress,

individualizing treatment, and evaluating therapies.

Monitoring of Diabetes Mellitus

Staffa et al (2016) stated that foot complications in persons with diabetes mellitus (DM)

are associated with substantial costs and loss of quality of life. Increasing evidence

suggests changes in skin temperature, measured using an IRT system, may be a

predictor of foot ulcer development in patients with DM. In a case study, these

researchers described the long-term IRT findings and overall clinical outcomes of a

patient with DM and peripheral vascular disease (PVD). Foot temperature

measurements using IRT were obtained slightly more than 1 year before and

immediately following endovascular treatment of a 76-year old man, a non-smoker with

type 2 DM, hypertension, and ischemic heart disease w ith cardiac arrhythmia. Although

he was otherwise asymptomatic, the infrared measurement showed an average

temperature difference of 2.3˚ C between the left and right foot until he developed a

small, trauma-induced wound on the left foot, at which time left foot temperature

increased. He was diagnosed with recto-sigmoid adenocarcinoma, underwent surgery

and chemotherapy, and subsequently was evaluated for PVD. Before undergoing

peripheral angiography and percutaneous transluminal angioplasty, IRT evaluation

showed a hot spot on the left heel. Immediately following endovascular treatment, the

mean temperature difference between the right and left foot was low (0.2˚ C), but a

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Stage I pressure ulcer was visible on the left heel. Skin breakdown in that area was

observed 2 months later, and the wound continued to increase in size and depth. The

patient died shortly thereafter due to complications of cancer. In this case study, a

series of infrared images of foot skin temperatures appeared to show a relationship with

blood circulation and wound/ulcer development and presentation. The authors

concluded that IRT has the ability to instantaneously measure the absolute temperature

of the skin surface over a large area without direct skin contact. However, they stated

that these devices are very sensitive; and prospective clinical studies are needed to

determine the validity, reliability, sensitivity, and specificity of these measurements for

routine use in patients who are at risk for vascular disease and/or foot ulcers.

Petrova and colleagues (2019) examined the usefulness of monthly thermography and

standard foot care to reduce diabetic foot ulcer recurrence. Individuals with diabetes (n

= 110), neuropathy and history of greater than or equal to 1 foot ulcer participated in a

multi-center, single-blind clinical trial. Feet were imaged with a novel thermal imaging

device (Diabetic Foot Ulcer Prevention System). Subjects were randomized to

intervention (active thermography + standard foot care [SOC]) or control (blinded

thermography + SOC) and were followed-up monthly until ulcer recurrence or for 12

months. Foot thermograms of subjects from the intervention group were assessed for

hot spots (areas with temperature greater than or equal to 2.2°C higher than the

corresponding contralateral site) and acted upon as per local standards. After 12

months, 62 % of subjects were ulcer-free in the intervention group and 56 % in the

control group. The odds ratios (ORs) of ulcer recurrence (intervention versus control)

were 0.82 (95 % CI: 0.38 to 1.8; p = 0.62) and 0.55 (95 % CI: 0.21 to 1.4; p = 0.22) in

uni-variate and multi-variate logistic regression analyses, respectively. The hazard

ratios (HRs) for the time to ulcer recurrence (intervention versus control) were 0.84 (95

% CI: 0.45 to 1.6; p = 0.58) and 0.67 (95 % CI: 0.34 to 1.3; p = 0.24) in uni-variate and

multi-variate Cox regression analyses, respectively. The authors concluded that monthly

intervention with thermal imaging did not result in a significant reduction in ulcer

recurrence rate or increased ulcer-free survival in this cohort at high-risk of foot ulcers.

However, this trial has informed the design of a refined study with longer follow-up and

group stratification, further aiming to examine the efficacy of thermography to reduce

ulcer recurrence.

Predicting Pressure Ulcers

In a systematic review, Oliveira and colleagues (2017) examined the clinical significance

of ultrasound (US), thermography, photography and sub-epidermal moisture (SEM)

measurement in detecting skin/tissue damage and thus predicting the presence of

pressure ulcers (PUs); determined the relative accuracy of one of these assessment

methods over another; and made recommendations for practice pertaining to

assessment of early skin/tissue damage. The following databases, Cochrane Wounds

Group Specialized Register, the Cochrane Central Register of Controlled Trials, Ovid

Medline, Ovid Embase, Elsevier version, Ebsco CINAHL, ClinicalTrials.gov , WHO

International Clinical Trials Registry (ICTR) and The EU Clinical Trials Register were

searched for terms including; thermography, ultrasound, sub-epidermal moisture,

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photograph and pressure ulcer. These investigators identified 4 SEM, 1 thermography

and 5 ultrasound studies for inclusion in this review. Data analysis indicated that

photography was not a method that allowed for the early prediction of PU presence;

SEM values increased with increasing tissue damage, with the sacrum and the heels

being the most common anatomical locations for the development of erythema and

stage I PUs. Thermography identified temperature changes in tissues and skin that may

give an indication of early PU development; however the data were not sufficiently

robust; US detected pockets of fluid/edema at different levels of the skin that were

comparable with tissue damage. Thus, SEM and US were the best methods for allowing

a more accurate assessment of early skin/tissue damage. Using the EBL Critical

Appraisal Tool, the validities of the studies varied between 33.3 to 55.6 %, meaning that

there is potential for bias within all the included studies. All of the studies were situated

at level IV, V and VII of the evidence pyramid. These researchers noted that although

the methodological quality of the studies warrants consideration, these studies showed

the potential that SEM and US have in early PU detection. The authors concluded that

SEM and US are promising in the detection and prediction of early tissue damage and

PU presence. However, they stated that these methods should be further studied to

clarify their potential for use more widely in PU prevention strategies.

Determining the Efficacy of Stroke Rehabilitation

Hegedus (2018) stated that maintaining good physiological circulation in the extremities

requires an optimally functioning muscle pump. Stroke symptoms indicate a change in

venous circulation. In this study, these researchers measured changes in joint function

and microcirculation, and the correlation between them. A total of 16 randomly selected

post-stroke patients with hemiparesis affecting mainly the upper extremities began

undergoing rehabilitation 13 ± 4 days following stroke. Thermograms were taken with a

Fluke Ti 20 (Fluke Corporation, WA) pre-treatment and post-treatment, and a

physiotherapy documentation form was completed. Treatment comprised 15

physiotherapy, massage, and galvanic therapy sessions per patient, with the side

exhibiting no neurological symptoms as a control. Joint function showed significant

improvement on the affected side (p < 0.05). Thermographic examinations revealed

microcirculatory dysfunction in the affected extremities in 100 % of the cases. Following

treatment, temperature increased significantly (p ≥ 0.5°C) on the affected side. A strong

correlation (r) was observed between joint function and temperature change (p < 0.05).

The authors concluded that thermography was shown to be a reliable method for

monitoring the effects of stroke rehabilitation treatment. They stated that thermographic

testing may enable clinicians to predict the course of the trauma and the effectiveness of

treatment even at the acute stage.

Thermography for Evaluating Acute Skin Toxicity of Breast Radiotherapy

Maillot and associates (2018) stated that radiotherapy is a common adjuvant treatment

of breast cancer. Acute radiation-induced dermatitis is a frequent side effect. These

researchers hypothesized whether it is possible to capture the increase of local

temperature as a surrogate of the inflammatory state induced by radiotherapy. They

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designed a prospective, observational, single-center study to acquire data on

temperature rise in the treated breast during the course of radiotherapy, establish a

possible association with the occurrence of dermatitis and examine the predictive value

of temperature increase in future occurrences of radiation-induced dermatitis. All

patients presenting for neoadjuvant or adjuvant radiotherapy during the course of breast

cancer treatment at the university hospital of Martinique were considered for inclusion.

Every week, patients were examined by 2 trained investigators for the occurrence of

radiation-induced dermatitis, graded based on Radiotherapy Oncology Group, Common

Terminology Criteria for Adverse Events v.4.0 and Wright scales. A frontal thermal

image of torso was taken in strictly controlled conditions, with a calibrated TE-Q1

camera (Thermal Expert, i3systems, Daejeon, Korea). These investigators studied

temperature differences between the irradiated breast or thoracic wall and the

contralateral area. For each thermal picture, these researchers measured the difference

in maximum temperature as well as the difference in minimum temperature and the

difference in the average temperature in the considered area. They studied the

evolution of these parameters over time (week after week), measuring the maximum

recorded difference and its correlation to acute radiation dermatitis intensity. A total of

64 consecutive patients were included. For all patients, these investigators noticed an

increase of temperature during the course of radiotherapy. Difference in maximum,

minimum and average temperature was higher between the 2 breasts of patients with a

radiation-induced dermatitis grade 2 or above compared to patients with no or mild

dermatitis. Higher temperatures were also significantly associated with an increased

sensation of discomfort, as recorded by questionnaire (p < 0.05). The authors

concluded that as expected from the inflammatory phenomena involved in radiation-

induced dermatitis, a noticeable increase in temperature during the course of

radiotherapy was observed in all patients. Furthermore, high-grade radiation-induced

dermatitis was strongly associated with an additional increase in local temperature,

which was probably linked to the intense inflammatory reaction. Lastly, with a 1.4°C

threshold set beforehand, it was possible to anticipate the occurrence of radiation-

induced dermatitis, with interesting positive and negative predictive values (PPV and

NPV) of 70 % and 77 %, respectively in this population. Moreover, these researchers

stated that these findings need to be confirmed in a dedicated study.

Thermography for Evaluating and Monitoring of Individuals Emery-Dreifuss Muscular Dystrophy

Cabizosu and colleagues (2018) noted that Emery-Dreifuss muscular dystrophy (EDMD)

is a clinical condition characterized by neuro-skeletal and cardiac impairments. By

means of thermography, new insights could be obtained regarding the evaluation and

follow-up of this disease. Actually, musculoskeletal disorders are a major cause of

counseling and access to rehabilitation services and are some of the most important

problems that affect the quality of life of many people. There are urgent clinical and

research needs for the assessment and follow-up of patients with EDMD. These

researchers offered a new possible hypothesis of validating thermographic techniques

that support the evaluation and clinical follow-up of the EDMD. They relied on evidence

of existing bibliography. These investigators performed a systematic review; and after

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the application of an automatic and manual filter, inclusion and exclusion criteria, no

study was obtained. There is a lack of evidence on the use of thermography in EDMD.

Due to a lack of information, these researchers expanded the search to studies

concerning the use of thermography in relation to alterations of the musculoskeletal

system compatible with those of EDMD, genetic diseases related to the X chromosome

and more generally muscular atrophy. Based on other studies performed in diseases

that showed signs and symptoms similar to EDMD, the authors believed that a new line

of translational research could be opened with novel findings and they thought

thermography could be an optimal tool for the clinical monitoring of this pathology.

These researchers believed that it would be of a great importance to carry out an

observational study, to lay the foundations for future work, that relate thermography to

EDMD.

Thermography for Joint Assessment in Individuals with Inflammatory Arthritis

Jones and associates (2018) noted that rheumatoid arthritis (RA) is a common

inflammatory disease that causes destruction of joints. Accurate recognition of active

disease has significant implications in determining appropriate treatment; however, there

is significant inter-rater variability in clinical joint assessment. In a cross-sectional study,

these researchers evaluated the use of thermographic imaging in the evaluation of

inflammatory arthritis activity as an adjunct to clinical assessment. This trial included 79

subjects recruited from the University of Alberta out-patient rheumatology clinic. These

investigators compared the hand joints of 49 patients with RA diagnosed by American

College of Rheumatology (ACR) criteria to 30 healthy volunteers. Convenience

sampling of consecutive RA patients was undertaken. The effect of clinical assessment

(HAQ and DAS-28) on joint temperature was evaluated using a linear mixed effect

model. A thermography camera, FLIR T300 model, 30-Hz, was used to obtain both

thermographic and digital images on subjects. Pearson's correlation coefficient was

used to assess the correlation of clinical assessments and average joint temperature

averaged over all joints. Thermographic analysis did not associate with clinical

measures of disease activity. In RA patients, there was no statistically significant

relationship between joint temperature and clinical assessment of disease activity

including Health Assessment Questionnaire (coefficient estimate - 0.54, p = 0.056),

swollen joints (coefficient estimate - 0.09, p = 0.238), or serologic markers of

inflammation such as C-reactive protein (CRP; coefficient estimate - 0.006, p = 0.602)

and erythrocyte sedimentation rate (ESR; coefficient estimate - 0.01, p = 0.503). The

authors concluded that evaluation of disease activity requires a multi-faceted approach

that includes clinical assessment and appropriate imaging. They stated that there may

be a role for thermography in assessment of larger joints; however, it does not appear to

be an effective modality for the small joints of the hand.

Thermography for Pre- and Peri-Operative Management of Hidradenitis Suppurativa

Derruau and co-workers (2018) stated that hidradenitis suppurativa (HS) is a chronic,

inflammatory, and recurrent skin disease. Surgical excision of wounds appears to be the

only curative treatment for the prevention of recurrence of moderate-to-severe stages;

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MRI is a standard reference examination for the detection of HS peri-anal inflammatory

fistula. In this case study, the use of real-time medical infrared thermography (MIT), in

combination with MRI as appropriate imaging, was proposed. The objective was to

assist surgeons in the pre- and peri-surgical management of severe perianal HS with the

intent to ensure that all diseased lesions were removed during surgery and therefore to

limit recurrence. The results showed that MIT, combined with MRI, could be a highly

effective strategy to address thermally distinguished health tissues and inflammatory

sites during excision, as characterized by differential increases in temperature. Medical

infrared thermography could be used to check the total excision of inflammatory lesions

as a non-invasive method that is not painful, not radiant, and is easily transportable

during surgery. The authors concluded that this method could be complementary with

MRI in providing clinicians with objective data on the status of tissues below the perianal

skin surface in the pre- and peri-operating management of severe HS. This was a

single-case study; its findings need to be validated by well-designed studies.

Infrared Thermography for Diagnosis and Management of Vasculitis, Early Identification of Skin Neoplasms, Esophageal Monitoring, and Screening for Adolescent Idiopathic Scoliosis

Lin and colleagues (2018) noted that vasculitis is a clinical condition with associated

diagnostic challenges due to non-specific symptoms and lack of a confirmatory imaging

modality. These investigators reported a case of a 39-year old woman who developed

generalized malaise, lethargy, and headache. Laboratory evaluation showed elevated

inflammatory markers. Conventional imaging studies including computed tomography

(CT) and carotid duplex ultrasound (US) were unremarkable. Infrared thermography

revealed enhanced thermographic signals in the left carotid artery and aortic arch.

Corticosteroid therapy was commenced, and the patient responded well. Follow-up

infrared thermography at 6 months showed complete resolution of the thermographic

pattern, and the patient remained symptom-free. The authors concluded that this case

highlighted the potential clinical utility of using infrared thermography in patients with

vasculitis. The enhanced thermal signals in the aortic arch and carotid artery provided

valuable information in the diagnosis and treatment of arteritis in this patient. This

technology was similarly beneficial in subsequent surveillance evaluation once the

patient completed the prescribed treatment. Moreover, they stated that further studies

are needed to determine the clinical sensitivity and diagnostic accuracy of this imaging

modality in vasculitis.

Magalhaes and associates (2018) stated that infrared thermal imaging captures the

infrared radiation emitted by the skin surface. The thermograms contain valuable

information, since the temperature distribution can be used to characterize physiological

anomalies. Thus, the use of infrared thermal imaging (IRT) has been studied as a

possible tool to aid in the diagnosis of skin oncological lesions. These researchers

evaluated the current state of the applications of IRT in skin neoplasm identification and

characterization. They carried out a literature survey using the reference bibliographic

databases: Scopus, PubMed and ISI Web of Science. Keywords (thermography,

infrared imaging, thermal imaging and skin cancer) were combined and its presence was

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verified at the title and abstract of the article or as a main topic. Only articles published

after 2013 were considered during this search. A total of 55 articles were encountered,

resulting in 14 publications for revision after applying the exclusion criteria. It was

denoted that IRT have been used to characterize and distinguish between malignant

and benign neoplasms and different skin cancer types; IRT has also been successfully

applied in the treatment evaluation of these types of lesions. The authors concluded

that trends and future challenges have been established to improve the application of

IRT in this field, disclosing that dynamic infrared thermography is a promising tool for

early identification of oncological skin conditions.

Daly and co-workers (2018) noted that catheter ablation for atrial fibrillation (AF) has

potential to cause esophageal thermal injury. Esophageal temperature monitoring

during ablation is commonly used; however, it has not eliminated thermal injuries,

possibly because conventional sensors have poor spatial sampling and response

characteristics. To enhance understanding of temperature dynamics that may underlie

esophageal injury, these researchers tested a high-resolution, intra-body, infrared

thermography catheter to continuously image esophageal temperatures during ablation.

Patients undergoing AF ablation were instrumented w ith a flexible, 9F infrared

temperature catheter inserted nasally (n = 8) or orally (n = 8) into the esophagus

adjacent to the left atrium. Ablation was performed while the infrared catheter

continuously recorded surface temperatures from 7,680 points/sec circumferentially over

a 6-cm length of esophagus. Physicians were blinded to temperature data. Endoscopy

was performed within 24 hours to document esophageal injury. Thermal imaging

showed that most patients (10/16) experienced greater than or equal to 1 events where

peak esophageal temperature was over 40° C; 3 patients experienced temperatures

over 50° C; and 1 experienced over 60 °C. Analysis of temperature data for each

subject's maximum thermal event revealed high gradients (2.3 ± 1.4° C/mm) and rates

of change (1.5 ± 1.3° C/sec) with an average length of esophageal involvement of 11.0 ±

5.4 mm. Endoscopy identified 3 distinct thermal lesions, all in patients with

temperatures over 50° C; all resolved within 2 weeks. The authors concluded that

infrared thermography provided dynamic, high-resolution mapping of esophageal

temperatures during cardiac ablation. Esophageal thermal injury occurred with

temperatures of over 50° C and was associated with large spatiotemporal gradients.

Moreover ,they stated that additional studies are needed to determine the relationships

between thermal parameters and esophageal injury.

In an editorial that accompanied the afore-mentioned study by Daly et al (2018), Borne

and Nguyen (2018) stated that “it is important to note the multiple limitations of

esophageal temperature monitoring. First, to be effective, esophageal monitoring must

accurately reflect the esophageal temperature. The esophagus is a broad and patulous

structure, and the position of a temperature probe might not align with the ablation

catheter such that monitoring might provide a false sense of security. In a prior

investigation in which 2 commercially available probes (9F esophageal probe and an

18F esophageal stethoscope) were used among patients undergoing ablation, there

were significant differences in the peak temperature and rise in temperature between the

probes, suggesting that significant temperature variation exists among frequently used

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temperature probes. Second, there is evidence to suggest that the use of a temperature

probe can be potentially harmful. In an ex vivo model, ablation near a non-insulated

multi-sensor esophageal probe significantly increased temperatures in the tissues

adjacent to the ablation lesion compared with lesions without a nearby temperature

probe. This was echoed in clinical work in which patients undergoing AF ablation were

enrolled prospectively to receive an esophageal temperature probe-guided ablation

strategy versus no temperature monitoring … The study has some notable limitations.

First, there is limited validation of this technology for esophageal temperature

monitoring. A previous report described the use of infrared probes to monitor

esophageal temperatures in a swine model, which were significantly higher than

conventional probes. The current authors reported their experience with the first-in-

human use of the IRTC in a patient undergoing PVI. Rigorous ex vivo and in vivo

experiments need to be performed, establishing best practices and limitations of this

technology, including how distance and location of the IRTC and ablation catheter affect

temperature readings, if interactions between radiofrequency ablation and the probe

exist and correlations to multiple different conventional temperature probes. Second,

lesions identified on endoscopy were not correlated to specific ablation lesions and their

characteristics (i.e., contact force, force-time integral). To best define risk for

esophageal injury and thereby allow for risk modification, ablation characteristics and

IRTC esophageal temperatures need to be analyzed. For instance, is the risk of

esophageal injury related to a time-temperature phenomenon, is it a structural/anatomic

phenomenon, or is it related other factors that result in visible injury in some but not

other ablation lesions causing temperatures >50° C? If lesions identified on endoscopy

did not correlate to higher esophageal temperatures, it is hard to know how temperature

monitoring would guide ablation … Although further work needs to be performed in

establishing the use of infrared thermography, the authors should be commended on

their work for developing a system that has the potential to provide useful temperature

monitoring data to improve the safety of AF catheter ablation. Although the question

remains as to what the optimal approach to avoid esophageal injury is, this study

provides evidence to suggest that more accurate esophageal temperature monitoring is

possible. Until then, we should remain on red alert for risks of esophageal injury, in

order to keep catheter ablation safe”.

Kwok and colleagues (2017) stated that adolescent idiopathic scoliosis (AIS) is a multi-

factorial, 3-D deformity of the spine and trunk. School scoliosis screening (SSS) is

recommended by researchers as a means of early detection of AIS to prevent its

progression in school-aged children. The traditional screening technique for AIS is the

forward-bending test because it is simple, non-invasive and inexpensive. Other tests,

such as the use of Moiré topography, have reduced the high false referral rates. These

researchers examined the use of infrared (IR) thermography for screening purposes

based on the findings of previous studies on the asymmetrical para-spinal muscle

activity of scoliotic patients compared with non-scoliotic subjects; IR thermography was

performed with an IR camera to determine the temperature differences in para-spinal

muscle activity. A statistical analysis showed that scoliotic subjects demonstrated a

statistically significant difference between the left and right sides of the regions of

interest. This difference could be due to the higher IR emission of the convex side of the

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observed area, thereby creating a higher temperature distribution. The authors

concluded that the findings of this study suggested the feasibility of incorporating IR

thermography as part of SSS. Moreover, they stated that future studies could also

consider a larger sample of both non-scoliotic and scoliotic subjects to further validate

the findings.

Intraoperative Infra-Red Thermography in Surgery of Glioblastoma Multiforme

Naydenov and colleagues (2017) noted that IRT is a real-time non-contact diagnostic

tool with a broad potential for neurosurgical applications. These researchers described

the intraoperative use of this technique in a single patient with newly diagnosed

glioblastoma multiforme (GBM). An 86-year old woman was admitted in the clinic with a

2-month history of slowly progressing left-sided paresis. Neuroimaging studies

demonstrated an irregular space-occupying process consistent with a malignant glioma

in the right fronto-temporo-insular region. An elective surgical intervention was

performed by using 5-aminolevulinic acid fluorescence (BLUE 400, OPMI) and

intraoperative IRT brain mapping (LWIR, 1.25 mRad IFOV, 0.05°C NETD). After dura

opening, the cerebral surface appeared inconspicuous. However, IRT revealed a

significantly colder area (Δt° 1.01°C), well corresponding to the cortical epicenter of the

lesion. The underlying tumor was partially excised and the histological result was GBM.

The authors concluded that intraoperative IRT appeared to be a useful technique for

subcortical convexity brain tumor localization. Moreover, they stated that further studies

with a large number of patients are needed to prove the reliability of this method in GBM

surgery.

Dynamic Infrared Blood Perfusion Imaging

Dynamic infrared blood perfusion imaging (DIRI) is a new infrared imaging technique

that is intended to detect changes in blood flow in tissue and organs by sensing

passively emitted infrared radiation from tissues. Potential clinical applications of DIRI

include: use as an adjunctive screening tool for breast cancer and other cancers;

evaluation of response to cancer chemotherapy; monitoring response to therapy in

diabetic peripheral vascular disease; identifying perforator vessels during pre-surgical

planning; assessing post-operative perfusion of pedicle flaps following reconstructive

surgery (i.e., of the breast); mapping of functional cortex in patients undergoing tumor

surgery; and determining cardiac bypass graft patency and perfusion of the myocardium

in cardiac surgery. Agostini and colleagues (2009) stated that dynamic infrared imaging

is a promising technique in breast oncology. Currently available evidence, however, is

limited to evaluations of DIRI's technical feasibility. There is an absence of evidence of

the impact of DIRI on health outcomes. The BioScanIR System (OmniCorder

Technologies, Inc., Bohemia, NY) is an example of a DIRI device that is commercially

available.

Lohman et al (2015) stated that over the last decade, microsurgeons have used a

greater variety of more complex flaps. At the same time, microsurgeons have also

become more interested in technology, such as indo-cyanine green (ICG) angiography,

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dynamic infra-red thermography (DIRT), and photo-spectrometry, for pre-operative

planning and post-operative monitoring. These technologies are now migrating into the

operating room, and are used to optimize flap design and to identify areas of hypo-

perfusion or problems with the anastomoses. Although relatively more has been

published about ICG angiography, information is generally lacking about the intra-

operative role of these techniques. A systematic analysis of articles discussing intra-

operative ICG angiography, DIRT, and photo-spectrometry was performed to better

define the sensitivity, specificity, expected outcomes, and potential complications

associated with these techniques. For intra-operative ICG angiography, the sensitivity

was 90.9 % (95 % confidence interval [CI]: 77.5 to 100) and the accuracy was 98.6 %

(95 % CI: 97.6 to 99.7). The sensitivity of DIRT was 33 % (95 % CI: 11.3 to 64.6), the

specificity was 100 % (95 % CI: 84.9 to 100), and the accuracy was 80 % (95 % CI: 71.2

to 89.7). The sensitivity of intra-operative photo-spectrometry was 92 % (95 % CI: 72.4

to 98.6), the specificity was 100 % (95 % CI: 98.8 to 100), and the accuracy was also

100 % (95 % CI: 98.7 to 100). The authors concluded that these technologies for intra-

operative perfusion assessment have the potential to provide objective data that may

improve decisions about flap design and the quality of microvascular anastomoses.

However, more work is needed to clearly document their value.

Just and colleagues (2016) investigated static IRT and DIRT for intra- and post-

operative free-flap monitoring following oropharyngeal reconstruction. A total of 16

patients with oropharyngeal reconstruction by free radial forearm flap were included in

this prospective, clinical study. Prior ("intraop_pre") and following ("intraop_post")

completion of the microvascular anastomoses, IRT was performed for intra-operative

flap monitoring. Further IR images were acquired 1 day ("postop_1") and 10 days

("postop_10") after surgery for post-operative flap monitoring. Of the 16, 15 transferred

free radial forearm flaps did not show any perfusion failure. A significant decreasing

mean temperature difference (∆T: temperature difference between the flap surface and

the surrounding tissue in Kelvin) was measured at all investigation points in comparison

with the temperature difference at "intraop_pre" (mean values on all patients: ∆T

intraop_pre = -2.64 K; ∆T intraop_post = -1.22 K, p < 0.0015; ∆T postop_1 = -0.54 K, p <

0.0001; ∆T postop_10 = -0.58 K, p < 0.0001). Intra-operative DIRT showed typical

pattern of non-pathological rewarming due to re-established flap perfusion after

completion of the microvascular anastomoses. The authors concluded that static and

dynamic IRT is a promising, objective method for intra-operative and post-operative

monitoring of free-flap reconstructions in head and neck surgery and to detect perfusion

failure, before macroscopic changes in the tissue surface are obvious. They noted that

a lack of significant decrease of the temperature difference compared to surrounding

tissue following completion of microvascular anastomoses and an atypical re-warming

following a thermal challenge are suggestive of flap perfusionfailure.

Dynamic Infrared Blood Perfusion Imaging (DIRI) for Assessment of Skin Blood Perfusion in Cranioplasty

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Rathmann and colleagues (2018) noted that complications in wound healing after

neurosurgical operations occur often due to scarred dehiscence with skin blood

perfusion disturbance. The standard imaging method for intra-operative skin perfusion

assessment is the invasive indocyanine green video angiography (ICGA). The non-

invasive dynamic infrared thermography (DIRT) is a promising alternative modality that

was evaluated by comparison with ICGA. These researchers performed a proof-of-

concept study for qualitative comparison of DIRT with the standard ICGA. This trial was

carried out in 2 parts: investigation of technical conditions for intra-operative use of DIRT

for its comparison with ICGA, and visual and quantitative comparison of both modalities

in 9 patients. Time-temperature curves in DIRT and time-intensity curves in ICGA for

defined regions of interest were analyzed. New perfusion parameters were defined in

DIRT and compared with the usual perfusion parameters in ICGA. The visual

observation of the image data in DIRT and ICGA showed that operation material,

anatomical structures and skin perfusion were represented similarly in both modalities.

Although the analysis of the curves and perfusion parameter values showed differences

between patients, no complications were observed clinically. These differences were

represented in DIRT and ICGA equivalently. The authors concluded that DIRT has

shown a great potential for intra-operative use, with several advantages over ICGA. The

technique is passive, contactless and non-invasive. The practicability of the intra-

operative recording of the same operation field section with ICGA and DIRT has been

demonstrated. These researchers stated that the promising results of this proof-of-

concept provided a basis for a trial with a larger number of patients.

Diagnosis of Temporomandibular Disorders

de Melo and colleagues (2019) systematically reviewed the scientific efficacy of infrared

thermography (IT) on the diagnosis of temporomandibular joint disorders (TMDs).

These researchers carried out an electronic search in 8 databases for publications up to

May 2018. Additionally, a hand-search of the reference lists was conducted. There

were no restrictions on language or on year of publication. Two independent reviewers

selected the studies, reviewed the abstract information, and assessed the quality. The

methodology of the included articles was evaluated by using the QUADAS-2 tool. A

total of 9 studies met the eligibility criteria and were included in the systematic review; 4

studies concluded that IT presented low accuracy or was not an accurate instrument for

TMD diagnosis, however, there was substantial variation in sensitivity, specificity, and

receiver operating characteristic curve values; 5 studies concluded that IT appeared to

be promising or may be a complementary diagnostic aid in the evaluation of TMDs.

These studies presented sensitivity values ranging from 70 % to 90 % and specificity

values ranging from 62 % to 92 %. All studies were judged as being "at risk of bias" and

as having "concerns regarding applicability". The authors concluded that the literature

is still lacking in sufficient number of studies regarding the reliability of IT for the

diagnosis of TMDs.

CPT Codes / HCPCS Codes / ICD-10 Codes

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Code Code Description

CPT codes not covered for indications listed in the CPB:

93740 Temperature gradient studies

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

A30.0 - A30.9 Leprosy [Hansen's disease]

B02.22 Postherpetic trigeminal neuralgia

B02.29 Other postherpetic nervous system involvement

C00.0 - C96.9 Malignant neoplasms

D18.00 -

D18.09

Hemangioma and lymphangioma, any site

E08.3211 -

E13.37x9

Diabetes mellitus

E10.51 ­

E10.59

E11.51 ­

E11.59

Diabetes mellitus with circulatory complications [Type 1 or 2]

G71.09 Other specified muscular dystrophies

G90.50 -

G90.59

Complex regional pain syndrome

H04.121 -

H04.129

Dry eye syndrome

I25.10 - I25.9 Coronary atherosclerosis

I73.9 Peripheral vascular disease, unspecified

I77.6 Arteritis, unspecified

L73.2 Hidradenitis suppurativa

L89.000 -

L89.95

Pressure ulcer

M06.4 Inflammatory polyarthropathy

M26.601 -

M26.69

Temporomandibular joint disorders

M79.601 -

M79.609

Pain in limb

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Code Code Description

M84.421S ­

M84.429S

M84.431S ­

M84.439S

S42.209S ­

S42.496S

S49.001S ­

S49.199S

S52.001S ­

S52.92xS

S59.001S ­

S59.299S

S62.90xS ­

S62.92xS

Fracture of upper extremity, sequela

S52.501+ ­

S52.509+

S52.531+ ­

S52.539+

Fracture of radius [open or closed]

T20.00xA -

T32.99

Burns

Y84.2 Radiological procedure and radiotherapy as the cause of abnormal

reaction of the patient, or of later complication, without mention of

misadventure at the time of the procedure

Z01.810 Encounter for preprocedural cardiovascular examination

Z01.818 Encounter for other preprocedural examination

Z01.89 Encounter for other specified special examinations [not covered for

intra-operative and post-operative perfusion assessment]

Z12.0 - Z12.9

Encounter for screening for malignant neoplasms

Z13.89 Encounter for screening for other disorder

Z51.11 -

Z51.12

Encounter for antineoplastic chemotherapy or immunotherapy

Z95.1 Presence of aortocoronary bypass graft

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2. American Academy of Neurology, Therapeutics and Technology Assessment

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modalities: Infrared thermography, spectrophotometric intracutaneous

analysis and laser Doppler imaging for the assessment of adult burns. Burns.

2015;41(8):1695-1707.

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detection of malignancy. Phys Med Biol. 2004;49:3105-3116.

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a new approach of studying Emery-Dreifuss muscular dystrophy by means of

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autonomic response in the hands of patients with leprosy. An Bras Dermatol.

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the diagnosis of temporomandibular disorders? A systematic review. Oral Surg

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21. Derruau S, Renard Y, Pron H, et al. Combining magnetic resonance imaging

(MRI) and medical Infrared thermography (MIT) in the pre- and peri-operating

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tool: A systematic review. N Z Med J. 2012;125(1351):80-91.

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coronary vulnerable plaques. Expert Rev Cardiovasc Ther. 2008;6(2):209-222.

28. Gatt A, Cassar K, Falzon O, et al. The identification of higher forefoot

temperatures associated with peripheral arterial disease in type 2 diabetes

mellitus as detected by thermography. Prim Care Diabetes. 2018;12(4):312-318.

29. Gradl G, Steinborn M, Wizgall I, et al. Acute CRPS I (morbus sudeck) following

distal radial fractures--methods for early diagnosis. Zentralbl Chir.

2003;128(12):1020-1026.

30. Hall A, Girkin JM. A review of potential new diagnostic modalities for caries

lesions. J Dent Res. 2004;83 Spec No C:C89-C94.

31. Han SS, Jung CH, Lee SC, et al. Does skin temperature difference as measured

by infrared thermography within 6 months of acute herpes zoster infection

correlate with pain level? Skin Res Technol. 2010;16(2):198-201.

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lumbosacral radiculopathy. Neurology. 1991;41:1010-1014.

33. Hegedus B. The potential role of thermography in determining the efficacy of

stroke rehabilitation. J Stroke Cerebrovasc Dis. 2018;27(2):309-314.

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34. Huygen FJ, Niehof S, Klein J, Zijlstra FJ. Computer-assisted skin

videothermography is a highly sensitive quality tool in the diagnosis and

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36. Janicek MJ, Demetri G, Janicek MR, et al. Dynamic infrared imaging of newly

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37. Jaspers MEH, van Haasterecht L, van Zuijlen PPM, Mokkink LB. A systematic

review on the quality of measurement techniques for the assessment of burn

wound depth or healing potential. Burns. 2019;45(2):261-281.

38. Jones B, Hassan I, Tsuyuki RT, et al. Hot joints: Myth or reality? A thermographic

joint assessment of inflammatory arthritis patients. Clin Rheumatol.

2018;37(9):2567-2571.

39. Just M, Chalopin C, Unger M, et al. Monitoring of microvascular free flaps

following oropharyngeal reconstruction using infrared thermography: First

clinical experiences. Eur Arch Otorhinolaryngol. 2016;273(9):2659-2567.

40. Kennedy DA, Lee T, Seely D. A comparative review of thermography as a breast

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42. Kim YS, Trillaud H, Rhim H, et al. MR thermometry analysis of sonication

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49. Madjid M, Naghavi M, Malik BA, et al. Thermal detection of vulnerable plaque.

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thermography in skin neoplasms. Skin Res Technol. 2018;24(4):587-591.

52. Maillot O, Leduc N, Atallah V, et al. Evaluation of acute skin toxicity of breast

radiotherapy using thermography: Results of a prospective single-centre trial.

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assessment and concept analysis. J Burn Care Res. 2015;36(6):626-635.

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Accessed January 4, 2012.

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of

coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract.

Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private

practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This

Clinical Policy Bulletin may be updated and therefore is subject to change.

Copyright © 2001-2020 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment toAetna Clinical Policy Bulletin Number: 0029

Thermography

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 03/10/2020

Proprietary