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Medical Policy

Policy Num:      06.001.064
Policy Name:    Thermography
Policy ID:          [06.001.064]  [Ar / B / M- / P-]  [6.01.12]

Last Review:     December 03, 2024
Next Review:     Policy Archived
 

Related Policies:

13.009.004 - Temporomandibular Joint Disorder
06.001.011 - Miscellaneous (Noncardiac, Nononcologic) Applications of Fluorine 18 Fluorodeoxyglucose Positron Emission Tomography
08.001.021 - Scintimammography and Gamma Imaging of the Breast and Axilla
06.001.043 - Cardiac Applications of Positron Emission Tomography Scanning
06.001.014 - Oncologic Applications of Positron Emission Tomography Scanning
06.001.010 - Magnetic Resonance Imaging for Detection and Diagnosis of Breast Cancer
06.001.041 - Interim Positron Emission Tomography Scanning in Oncology to Detect Early Response During Treatment

Thermography

Summary

Summary

Description

Thermography is a noninvasive imaging technique that measures temperature distribution in organs and tissues. The visual display of this temperature information is known as a thermogram. Thermography has been proposed as a diagnostic tool for treatment planning and for evaluation of treatment effects for a variety of conditions.

Summary of Evidence

For individuals who have an indication for breast cancer screening or diagnosis who receive thermography, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, and test validity. Using histopathologic findings compared to the reference standard, a series of systematic reviews of studies have evaluated the accuracy of thermography to screen and/or diagnose breast cancer and reported wide ranges of sensitivities and specificities. To date, no study has demonstrated that thermography is sufficiently accurate to replace or supplement mammography for breast cancer diagnosis. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with breast cancer. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have musculoskeletal injuries who receive thermography, the evidence includes diagnostic accuracy studies, a longitudinal prospective study, and a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing musculoskeletal injuries found moderate levels of accuracy compared with other diagnostic imaging tests. There is no consistent reference standard. This evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no high-quality or randomized studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have temporomandibular joint (TMJ) disorder who receive thermography, the evidence includes a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing TMJ disorder found a wide variation in accuracy compared to other diagnostics. There is no consistent reference standard. The evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with the TMJ disorder. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have miscellaneous conditions (eg, herpes zoster, pressure ulcers, diabetic foot) who receive thermography, the evidence primarily includes diagnostic accuracy studies. Outcomes in these studies are test validity, symptoms, and functional outcomes. Most studies assessed temperature gradients or the association between temperature differences and the clinical condition. Due to the small number of studies for each indication, diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography has only been considered in a single study of diabetic foot ulcers. For other miscellaneous conditions, the clinical utility of thermography has not been investigated. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether thermography improves the net health outcome for a variety of indications including but not limited to the diagnosis of breast cancer, musculoskeletal injuries, and temporomandibular joint disorder.

Policy

The use of all forms of thermography is considered investigational.

Policy Guidelines

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Infrared radiation from the skin or organ tissue reveals temperature variations by producing brightly colored patterns on a liquid crystal display. Thermography involves the use of an infrared scanning device and can include various types of telethermographic infrared detector images and heat-sensitive cholesteric liquid crystal systems.

Interpretation of the color patterns is thought to assist in the diagnosis of many disorders such as complex regional pain syndrome (previously known as reflex sympathetic dystrophy), breast cancer, Raynaud phenomenon, digital artery vasospasm in hand-arm vibration syndrome, peripheral nerve damage following trauma, impaired spermatogenesis in infertile men, degree of burns, deep vein thrombosis, gastric cancer, tear-film layer stability in dry-eye syndrome, Frey syndrome, headaches, lower back pain, and vertebral subluxation.

Thermography may also assist in treatment planning and procedure guidance by accomplishing the following tasks: identifying restricted areas of perfusion in coronary artery bypass grafting, identifying unstable atherosclerotic plaques, assessing response to methylprednisone in rheumatoid arthritis, and locating high undescended testicles.

Regulatory Status

A number of thermographic devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA product codes: LHQ, FXN. Devices with product code LHQ may only be marketed for adjunct use. Devices with product code FXN do not provide a diagnosis or therapy. Examples of these devices are shown in Table 1.

Table 1. Thermography Devices Cleared by the U.S. Food and Drug Administration

Rationale

This evidence review was created in March 1996 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through July 26, 2024.

Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Breast Cancer Screening or Diagnosis

Clinical Context and Test Purpose

The purpose of using thermography in individuals undergoing breast cancer screening or diagnosis is to inform decisions on diagnosis and treatment.

The following PICO was used to select literature to inform this review.

Populations

The relevant populations of interest are asymptomatic individuals being screened for breast cancer or individuals undergoing testing to diagnose breast cancer.

Interventions

The intervention of interest is thermography.

Comparators

The following test is currently being used to make decisions about breast cancer diagnosis: mammography.

Outcomes

The outcome of interest for diagnostic accuracy is test validity (ie, sensitivity, specificity). The primary outcomes of interest for clinical utility are overall survival and breast cancer-specific survival rates.

The potential beneficial outcomes of primary interest in the case of a true-negative would be the avoidance of unnecessary surgery and associated consequences (eg, morbidity, mortality, resource utilization, patient anxiety). The potential harms from a false-positive could be inappropriate assessment and improper management of patients with breast malignancies, which could result in the following: inappropriate surgical decisions, high frequency of unnecessary further testing, and unnecessary patient anxiety. The potential harms from a false-negative could be a determination that the patient does not have malignancy, which would lead to a delay in surgery and tumor diagnosis.

The timing for routine screening can be guided by national guidelines on breast cancer screening. The timing for diagnosis would be after an initial screening test or clinical examination.

Study Selection Criteria

For the evaluation of clinical validity of thermography for breast cancer, studies that meet the following eligibility criteria were considered:

• Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores);

• Included a suitable reference standard;

• Patient/sample clinical characteristics were described;

• Patient/sample selection criteria were described.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Review of Evidence

Systematic Reviews

Several systematic reviews of the published literature on the diagnostic accuracy of thermography were identified. A systematic review by Vreugdenburg et al (2013) identified 8 studies on thermography for diagnosis of breast cancer that included a valid reference standard (eg, biopsy with histopathologic confirmation).^1, A previous systematic review by Fitzgerald and Berentson-Shaw (2012) identified 6 studies, 1 using thermography for breast cancer screening and the others using thermography to diagnose breast cancer among symptomatic women or those with a positive mammogram.^2, A summary of the characteristics of clinical validity for these systematic reviews is provided in Table 2. A summary of the clinical validity results is provided in Table 3. Study findings were not pooled due to heterogeneity in data reporting and assessment methodology utilized.

Table 2. Systematic Reviews: Characteristics of Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

Table 3. Systematic Reviews: Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

Diagnostic Studies

Several studies have been published since the systematic reviews. Morales-Cervantes et al (2018) compared the accuracy of automated or manual thermography screening in 206 women scheduled for mammography in Mexico.^3, A retrospective study conducted in the U.S. by Neal et al (2018) assessed outcomes in 38 women referred for further breast imaging following abnormal thermography testing.^4, Omranipour et al (2016) compared the accuracy of thermography and mammography in 132 patients in Iran who had breast lesions and were candidates for breast biopsy.^5, Rassiwala et al (2014) in India reported on 1008 women being screened for breast cancer.^6, Summaries of characteristics and results of clinical validity for these diagnostic studies are provided in Tables 4 and 5.

Table 4. Diagnostic Study Characteristics of Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

Table 5. Clinical Validity of Thermography in Breast Cancer Screening or Diagnosis

The diagnostic accuracy of automated thermography in the study by Morales-Cervantes et al (2018) was 69.9%.^3, The authors did not report on the diagnostic accuracy of manual thermography. While automated thermographic screening improved the sensitivity and specificity of the test compared to a manual, qualitative approach, reported values must be interpreted with caution as only patients with positive mammograms were subjected to diagnostic reference testing. Neal et al (2018) indicated that 95% of patients referred for follow-up imaging evaluation following abnormal thermography testing did not have breast cancer, concluding that conventional breast imaging appears sufficient to manage patients.^4, According to Omranipour et al (2016),^5, the diagnostic accuracy of thermography (67.7%) was lower than for mammography (76.9%; p values not reported). The reported false-negative rate was not accurately calculated in Rassiwala et al (2014) because women who had normal thermograms only had a clinical examination and did not undergo radiologic and histopathologic reference tests for confirmation, highlighting a major limitation of this study.^6, For patients with positive or abnormal thermograms, 8 results were considered false-positive. One false-negative was reported, but it is unclear which subgroup this patient belonged to or how this was determined, given that patients with normal thermograms were only assessed with a clinical examination. Tables 6 and 7 display further notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 6. Study Relevance Limitations: Breast Cancer Screening or Diagnosis

Table 7. Study Design and Conduct Limitations: Breast Cancer Screening or Diagnosis

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, more effective therapy, or avoid unnecessary therapy or testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials (RCTs).

No studies have demonstrated how the results of thermography could be used to enhance the management of breast cancer patients in a manner that would improve their health outcomes.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as mammographic techniques for breast cancer screening and diagnosis.

Section Summary: Breast Cancer Screening or Diagnosis

Systematic reviews of studies evaluating the accuracy of thermography for diagnosing breast cancer found wide ranges of sensitivities and specificities and, where data are available, relatively low diagnostic accuracy compared with mammography. To date, no study has demonstrated that thermography is sufficiently accurate to replace or supplement mammography for breast cancer diagnosis. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with breast cancer.

For individuals who have an indication for breast cancer screening or diagnosis who receive thermography, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, and test validity. Using histopathologic findings compared to the reference standard, a series of systematic reviews of studies have evaluated the accuracy of thermography to screen and/or diagnose breast cancer and reported wide ranges of sensitivities and specificities. To date, no study has demonstrated that thermography is sufficiently accurate to replace or supplement mammography for breast cancer diagnosis. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with breast cancer. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 2

Musculoskeletal Injuries

Clinical Context and Test Purpose

The purpose of using thermography in individuals who have a musculoskeletal injury is to inform a decision whether to proceed to appropriate treatment or not.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with musculoskeletal injuries.

Interventions

The intervention of interest is thermography.

Comparators

The following tests and practices are currently being used to make decisions about musculoskeletal injuries: standard care without imaging and other forms of imaging (eg, with radiography, magnetic resonance imaging).

Outcomes

The outcomes of interest for diagnostic accuracy include test accuracy and test validity (ie, sensitivity, specificity). The primary outcomes of interest for clinical utility are a reduction in pain symptoms and improvement in functional ability. The timing would be following a musculoskeletal injury.

Study Selection Criteria

For the evaluation of clinical validity of thermography, studies that meet the following eligibility criteria were considered:

• Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores);

• Included a suitable reference standard;

• Patient/sample clinical characteristics were described;

• Patient/sample selection criteria were described.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Review of Evidence

Systematic Reviews

A systematic review by Sanchis-Sanchez et al (2014) evaluated the literature on thermography for diagnosing musculoskeletal injuries.^7,Six studies met the eligibility criteria (N=416); 3 included patients with suspected stress fractures (n=119) and the remainder addressed other musculoskeletal injuries. Characteristics and results of clinical validity for stress fracture diagnostic studies were reported and summaries are provided in Tables 8 and 9. A systematic review by Vardasca et al (2019) evaluated the literature on musculoskeletal applications of thermography specific to the arm and forearm. However, the review mainly focused on correlations between skin surface temperatures and physical condition or health recovery monitoring. As diagnostic accuracy data were not extracted or pooled from included studies, this review was not assessed for evidence of clinical validity.

Table 8. Systematic Review: Characteristics of Clinical Validity of Thermography in Musculoskeletal Injury

Table 9. Systematic Review: Clinical Validity of Thermography in Musculoskeletal Injury

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, more effective therapy, or avoid unnecessary therapy or testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

Longitudinal Studies

Côrte et al (2019) published pilot data from a longitudinal prospective study on the screening and prevention of muscle injuries in 28 professional Brazilian soccer players.^8, Players were monitored for musculoskeletal imaging during the 2015-2016 seasons with ultrasound. In the second season, a thermographic monitoring regimen was added twice-weekly 48 hours after matches, and an injury prevention protocol was followed based on the results of thermographic imaging. The number of musculoskeletal injuries was compared for both seasons based on these management protocols. The total number of muscle injuries reported decreased from 11 in 2015 to 4 in 2016 (p=.04). Seven players were on the team roster across both seasons. There was no statistically significant reduction in muscle injury in this subgroup (p=.06). Limitations of this study are addressed in Tables 10 and 11.

Table 10. Study Relevance Limitations: Musculoskeletal Injury

Table 11. Study Design and Conduct Limitations: Musculoskeletal Injury

No high-quality or randomized studies have been published that evaluate health outcomes in patients with musculoskeletal injuries who were managed with and without thermography.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as standard techniques for diagnosing musculoskeletal injuries.

Section Summary: Musculoskeletal Injuries

A systematic review of studies on thermography for diagnosing musculoskeletal injuries found moderate levels of accuracy compared with other diagnostic imaging tests. There was a lack of a consistent reference standard. This evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are insufficient studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries.

For individuals who have musculoskeletal injuries who receive thermography, the evidence includes diagnostic accuracy studies, a longitudinal prospective study, and a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing musculoskeletal injuries found moderate levels of accuracy compared with other diagnostic imaging tests. There is no consistent reference standard. This evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no high-quality or randomized studies on the impact of thermography on patient management or health outcomes for patients with musculoskeletal injuries. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3

Temporomandibular Joint Disorder

Clinical Context and Test Purpose

The purpose of using thermography in individuals who have temporomandibular joint (TMJ) disorder is to inform a decision whether to proceed to appropriate treatment or not.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with TMJ disorder.

Interventions

The intervention of interest is thermography.

Comparators

The following tests and practices are currently being used to make decisions about TMJ disorder: standard clinical examination without imaging, diagnostic scales (eg, Research Diagnostic Criteria for Temporomandibular Disorders [RDC/TMD], Fonseca Anamnestic Index, Anamnestic Index), and other forms of imaging (eg, with radiography, arthrotomography, magnetic resonance imaging).

Outcomes

The outcomes of interest for diagnostic accuracy include test accuracy and test validity (ie, sensitivity, specificity). The primary outcomes of interest for clinical utility are a reduction in pain symptoms and improvement in functional ability.

Study Selection Criteria

For the evaluation of clinical validity of thermography for TMJ disorder, studies that meet the following eligibility criteria were considered:

• Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores);

• Included a suitable reference standard;

• Patient/sample clinical characteristics were described;

• Patient/sample selection criteria were described.

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Review of Evidence

Systematic Reviews

A systematic review by de Melo et al (2019) evaluated the diagnostic accuracy of infrared thermography in TMJ disorder.^9, Nine studies were identified utilizing a variety of comparators. The authors note that while no specific diagnostic tool is currently considered the gold standard for the diagnosis of TMJ disorder, the RDC/TMD diagnostic is commonly used with a reported sensitivity and specificity of 87% and 92%, respectively. Four out of 9 studies utilized RDC/TMD, whereas the remaining studies utilized clinical examination or other methods. Characteristics and results of clinical validity for TMJ disorder diagnostic accuracy in this systematic review are summarized in Tables 12 and 13.

Table 12. Systematic Review: Characteristics of Clinical Validity of Thermography in Temporomandibular Joint Disorder

Table 13. Systematic Review: Clinical Validity of Thermography in Temporomandibular Joint Disorder

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, more effective therapy, or avoid unnecessary therapy or testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from RCTs.

No studies have been published that evaluate health outcomes in patients with TMJ disorder who were managed with and without thermography.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

It is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence that the diagnostic accuracy of thermography is at least as high as standard techniques for diagnosing TMJ disorder.

Section Summary: Temporomandibular Joint Disorder

A systematic review of studies on thermography for diagnosing TMJ disorder found a wide variation in accuracy compared with other diagnostics. There was a lack of a consistent reference standard. This evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with TMJ disorder.

For individuals who have temporomandibular joint (TMJ) disorder who receive thermography, the evidence includes a systematic review. Relevant outcomes are test validity, symptoms, and functional outcomes. A systematic review of studies on thermography for diagnosing TMJ disorder found a wide variation in accuracy compared to other diagnostics. There is no consistent reference standard. The evidence does not permit conclusions as to whether thermography is sufficiently accurate to replace or supplement standard testing. Moreover, there are no studies on the impact of thermography on patient management or health outcomes for patients with the TMJ disorder. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4

Miscellaneous Conditions

A number of studies have assessed a range of potential thermography applications. To date, no randomized study has examined the impact of thermography on patient management decisions or health outcomes. Examples of other studies on thermography, mainly conducted outside of the U.S., include those evaluating the association between thermographic findings and post-herpetic neuralgia in patients with herpes zoster,^10,11, surgical site healing in patients who underwent knee replacements,^12,predicting pressure ulcers^13, and pressure ulcer healing,^14,15, posttreatment pain in patients with coccygodynia,^16, evaluation of allergic conjunctivitis,^17, evaluation of burn depth,^18,19, association between thermographic findings and burn treatment,^20, detecting cervical lymph node metastasis from oral cavity cancer,^21, monitoring lesions or inflammation in patients with scleroderma,^22,23, detection of vascular obstruction^24, or perforator vessels during surgery,^25,26, diagnosis of lower extremity cellulitis,^27, prediction of infrainguinal bypass surgery,^28, detection of melanoma,^29, detection of contact dermatitis during allergy patch testing,^30,diagnosis of acute appendicitis,^31,and measuring disease activity in patients with rheumatoid arthritis, osteoarthritis, or other rheumatic diseases.^32,33,34,35,

Several studies evaluating the clinical validity of thermography to assess potential complications of the diabetic foot have been conducted. Thermographic images of nondiabetic feet, nonulcerated diabetic feet, and ulcerated diabetic feet have been compared.^{36,37,38,39,40,} Another study used thermography to diagnose infections in patients admitted with diabetic foot complications.^41, The only study to date to investigate the clinical utility of thermography compared with no thermography assessed diabetic foot ulcer incidence in 110 participants with a history of diabetic neuropathy and foot ulcers.^42, After 12 months followup, the study found no significant difference between use of monthly thermography versus no thermography and foot ulcer incidence (62% vs. 56%; adjusted odds ratio, 0.55, 95% confidence interval [CI], 0.21 to 1.40) or time to ulcer recurrence (adjusted hazard ratio, 0.67, 95% CI, 0.34 to 1.3).

Section Summary: Miscellaneous Conditions

For most of these potential indications, there are 1 or 2 preliminary studies on each of the indications. Several studies evaluated the clinical validity of thermography in assessing diabetic foot and related complications. For all indications, the studies described temperature gradients or the association between temperature differences and the clinical condition. Due to the small number of studies for each indication, the diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography for these miscellaneous conditions was not investigated in any study.

For individuals who have miscellaneous conditions (eg, herpes zoster, pressure ulcers, diabetic foot) who receive thermography, the evidence primarily includes diagnostic accuracy studies. Outcomes in these studies are test validity, symptoms, and functional outcomes. Most studies assessed temperature gradients or the association between temperature differences and the clinical condition. Due to the small number of studies for each indication, diagnostic accuracy could not adequately be evaluated. The clinical utility of thermography has only been considered in a single study of diabetic foot ulcers. For other miscellaneous conditions, the clinical utility of thermography has not been investigated. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

European Society of Breast Imaging

A position paper by the European Society of Breast Imaging (2017) and 30 other national breast radiology bodies on screening for breast cancer stated that "screening with thermography or other optical tools as alternatives to mammography is discouraged."^43,

American College of Obstetricians and Gynecologists

The American College of Obstetricians and Gynecologists (ACOG) practice bulletin for breast cancer risk assessment and screening in average-risk women do not mention the use of thermography for breast cancer screening.^44,

American College of Physicians

The American College of Physicians (2019) issued a guidance statement for breast cancer screening in average-risk women that reviews existing screening guidelines.^45, While the use of thermography was not mentioned in this statement, the authors concluded that evidence is insufficient to understand the benefits and harms of primary or adjunctive screening strategies in women who are found to have dense breasts on screening mammography.

American College of Radiology

The American College of Radiology updated 2023 guidelines for female breast cancer screening do not mention the use of thermography for breast cancer screening.^46,

National Comprehensive Cancer Network

National Comprehensive Cancer Network guideline on breast cancer screening and diagnosis (v.2.2024 ) states that: "Current evidence does not support the routine use of thermography as screening procedures."^47,

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force ( 2024) recommendations on breast cancer screening (currently undergoing an update) do not mention thermography. Additionally, there is insufficient evidence for the use of adjunctive screening methods for breast cancer (ultrasonography or magnetic resonance imaging ) in women identified to have dense breasts on a negative screening mammogram.^48,

Medicare National Coverage

Medicare does not cover thermography. Current Medicare coverage policy states: "Thermography for any indication (including breast lesions which were excluded from Medicare coverage …) is excluded from Medicare coverage because the available evidence does not support this test as a useful aid in the diagnosis or treatment of illness or injury. Therefore, it is not considered effective..."^49,

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 14.

Table 14. Summary of Key Trials

References

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2. Fitzgerald A, Berentson-Shaw J. Thermography as a screening and diagnostic tool: a systematic review. N Z Med J. Mar 09 2012; 125(1351): 80-91. PMID 22426613
3. Morales-Cervantes A, Kolosovas-Machuca ES, Guevara E, et al. An automated method for the evaluation of breast cancer using infrared thermography. EXCLI J. 2018; 17: 989-998. PMID 30564079
4. Neal CH, Flynt KA, Jeffries DO, et al. Breast Imaging Outcomes following Abnormal Thermography. Acad Radiol. Mar 2018; 25(3): 273-278. PMID 29275941
5. Omranipour R, Kazemian A, Alipour S, et al. Comparison of the Accuracy of Thermography and Mammography in the Detection of Breast Cancer. Breast Care (Basel). Aug 2016; 11(4): 260-264. PMID 27721713
6. Rassiwala M, Mathur P, Mathur R, et al. Evaluation of digital infra-red thermal imaging as an adjunctive screening method for breast carcinoma: a pilot study. Int J Surg. Dec 2014; 12(12): 1439-43. PMID 25448668
7. Sanchis-Sánchez E, Vergara-Hernández C, Cibrián RM, et al. Infrared thermal imaging in the diagnosis of musculoskeletal injuries: a systematic review and meta-analysis. AJR Am J Roentgenol. Oct 2014; 203(4): 875-82. PMID 25247955
8. Côrte AC, Pedrinelli A, Marttos A, et al. Infrared thermography study as a complementary method of screening and prevention of muscle injuries: pilot study. BMJ Open Sport Exerc Med. 2019; 5(1): e000431. PMID 30687515
9. de Melo DP, Bento PM, Peixoto LR, et al. Is infrared thermography effective in the diagnosis of temporomandibular disorders? A systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. Feb 2019; 127(2): 185-192. PMID 30482738
10. 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. May 2010; 16(2): 198-201. PMID 20456100
11. Park J, Jang WS, Park KY, et al. Thermography as a predictor of postherpetic neuralgia in acute herpes zoster patients: a preliminary study. Skin Res Technol. Feb 2012; 18(1): 88-93. PMID 21605168
12. Romanò CL, Logoluso N, Dell'Oro F, et al. Telethermographic findings after uncomplicated and septic total knee replacement. Knee. Jun 2012; 19(3): 193-7. PMID 21441031
13. Oliveira AL, Moore Z, O Connor T, et al. Accuracy of ultrasound, thermography and subepidermal moisture in predicting pressure ulcers: a systematic review. J Wound Care. May 02 2017; 26(5): 199-215. PMID 28475447
14. Nakagami G, Sanada H, Iizaka S, et al. Predicting delayed pressure ulcer healing using thermography: a prospective cohort study. J Wound Care. Nov 2010; 19(11): 465-6, 468, 470 passim. PMID 21135794
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