Thermography - Medical Clinical Policy Bulletins | Aetna (https://www.aetna.com/) 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 of myofascial trigger points Detection and screening for breast cancer Detection of rupture-prone vulnerable coronary plaque Determination of the efficacy of stroke rehabilitation Diagnosis of complex regional pain syndrome Diagnosis of musculoskeletal injuries Diagnosis and management of vasculitis 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 of 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. Proprietary 1/31
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Thermography - Medical Clinical Policy Bulletins | Aetna
(https://www.aetna.com/)
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
Thermography - Medical Clinical Policy Bulletins | Aetna
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
Thermography - Medical Clinical Policy Bulletins | Aetna
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.