The IoT advantages and disadvantages.
\r\n\tgas sensors.
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By assigning a unique identification to each object in the network, IoT allows its users to live smart, safe lives. In healthcare systems, IoT is mainly used to gain quick access to health information. IoT can be defined as an interconnected network that links a large number of devices to one another for purposes of making large-scale information accessible to all. This technology can be seen as a grid of computers that deliver software and data via the Internet. As illustrated in Figure 1, Cisco defines IoT as a revolution of the ‘Internet of Everything’ that involves people, processes, data and things [1].
IoT revolution [
Many health organisations need to exchange data with one another to address their problems and to improve their performance [1]. Health-related data are especially important for these organisations to provide their patients with better healthcare services. The exchange of health information among these organisations has been termed ‘health information exchange (HIE)’, which has become a pervasive global phenomenon [2, 3]. Although not a novel concept in the health industry, HIE needs to reinvent itself every 2.5 years to adapt to the current technological advancements and the changes in the environment [4]. According to the ‘Evolution of State Health Information Exchange in the U.S. (2006)’, HIE offers many significant contributions to the designing of different projects, such as financing, identifying patterns of success, ensuring programmatic sustainability and highlighting challenges, trends and best practices [5]. HIE also provides many opportunities to improve the quality and reduce the cost of healthcare, improve the workflows of clinical organisations and facilitate the administration of data within the healthcare system [5]. However, HIE also poses one of the most complex problems in electronic health record (EHR) management [6]. Therefore, dissemination and communication are essential attributes of health information systems [7].
The medical records of each patient are stored in physical and electronic databases. However, when patients decide to move to new healthcare providers, the latter have no tools or directories that they can use to check where the medical records of these patients are stored. Such inaccessibility of medical records can lead to unnecessary procedures, duplicate tests and many other problems, such as adverse drug interaction. According to Tharmalingam et al. [8], Canada faces many difficulties related to HIE, including complex systems, lack of knowledge as to the location of patients’ medical records, lack of access to information and lack of data standards that allow the exchange of clinical information. Some non-technological barriers also exist, including care burden, issues related to patient consent, differences in business models, limited understanding of procedures and loss of competitive advantage [2, 9].
Virtually storing patient data and making them ubiquitously accessible to all healthcare personnel is the first step in HIE [10]. Recent years have witnessed an increasing interest in the application of sensing technologies and widely available smart devices for monitoring personal health, fitness and activity. Continuously recording key physiological parameters via sensors can provide healthcare practitioners with the necessary data to produce rich longitudinal records [11]. Meanwhile, data from physical examinations provide doctors with comprehensive information that allows them to measure the physiological and metabolic states of their patients. Accessing a large number of observation data via health information systems can also help doctors improve their prognosis for their patients and recommend effective treatment, intervention and lifestyle choices to improve their health quality [12].
With the massive advancements in communication and computer technologies, organisations must urgently apply and utilise these technologies to compete effectively and survive in the market. IoT cannot improve the performance of hospitals if such technology is not being utilised to measure the success of a system [13]. A vast and multi-layered infrastructure of ubiquitous computing technologies and applications is also emerging. Mobile phones, laptops, Wi-Fi, Bluetooth, personal digital assistants and various forms of sensing devices based on digital and radio frequency identification (RFID) technologies have also penetrated the healthcare industry. IoT establishes connections among different entities, including humans (e.g. patients and medical staff), medical devices, intelligent wheelchairs, wireless sensors and mobile robots. People in the healthcare industry also rely on this technology to provide high-quality and affordable healthcare services, minimise medical errors, guarantee the safety of their patients and optimise their healthcare processes [14].
However, despite the wide availability of smart devices and novel communication technologies, healthcare professionals and patients are still generally unwilling to exchange health information while a large number of hospitals are yet to implement advanced technologies to promote their HIE capability [15, 16, 17]. IoT provides new opportunities for healthcare professionals to deliver health information to hard-to-reach populations. Utilising such technology often requires an organisation to spend a considerable amount of resources at different stages [18]. Unfortunately, most health organisations in developing countries only have few resources to spare for using new technologies, including IoT [19]. Many other issues also prevent these hospitals from receiving financial incentives that will enable them to adopt new technologies for facilitating HIE.
In sum, using IoT is in great demand in the healthcare sector. To effectively utilise IoT, hospitals must possess the necessary resources to produce the maximum value possible and to prevent failure [20]. Therefore, this chapter focuses on those problems being faced by the healthcare industry in its implementation of advanced technologies. Over the past 5 years, many health information systems have faced several concerns with regard to medical records. Most of these systems have focused on accelerating their provision of services to patients and improving the performance of hospitals by reconstructing their current workflows.
The rapid proliferation of smart devices offers unprecedented opportunities for patients and health care professionals to exchange health information electronically [16]. The IoT is one of the smart technologies to integrate the smart devices on network. On the other hand, IoT is a global information infrastructure that enables advanced services by interconnecting devices based on existing and evolving interoperable information and communication technologies [21]. Thus, it is a collection of several opportunities that have wellness providing for the hospitals such as optimising the resources through automated workflows as well as process excellence. For instance, a majority of hospitals use IoT services for asset management and controlling humidity and temperature within operating rooms [22]. The collection of health data has multiple benefits to interdisciplinary healthcare collaboration, while most of the research focuses on the personal fitness plan and has a lack of compatibility and extensibility among a large number of devices and their business models. Compatibility involves in information exchanging, communication and events processing. There is a strong need for an efficient interface mechanism to simplify the management and interconnection of things. However, the compatibility issue among the heterogeneous devices should be taken into consideration and addressed for the interactions among things [23].
Figure 2 illustrates how this revolution in the medical will look in a typical IoT hospital, in practice. The patient will have an ID card, which, when scanned, links to a secure cloud which stores their electronic health record vitals and lab results and medical and prescription histories.
IoT-hospital scenario [
The IoT has the potential to several benefits for health applications such as remote health monitoring, fitness programs, chronic diseases, children care and elderly care. Furthermore, it allows sharing and controlling the information between human to human or human-object or between objects using the Internet via ubiquitous sensors [24]. Therefore, various medical devices, sensors, and diagnostic and imaging devices can be viewed as smart devices or objects constituting a core part of the IoT [12]. The IoT-based e-Health monitoring method will help in reducing the number of visits to a doctor, and even the doctor can monitor his or her patient from anywhere. As this is a technology not so feasible now, but in coming years, this technology will meet the physical world definitely. The e-Health solutions provided through IoT devices are more accurate and accountable in the emerging IoT business landscape, which offers and provides various opportunities and challenges to an industry [25].
The IoT technology is still understudy to utilise it in the health sector in different regions in order to combine the information with control and monitoring such as China, US, Canada, etc. As a historical background, the Internet of Things was discovered by Kevin Ashton in 1998 to facilitate information exchange over the wide-world where every physical object connected through the Internet with a unique identification and can be monitored everywhere. One of the facilities of IoT for information systems is that it can provide services anywhere, anytime, and on any media [24]. In healthcare, the Internet of Things enables the potential benefits to achieve a high rate of exchange of massive information among organisations and organisation itself.
Some advantages of using Internet treatments included self-paced, interactive, of tailored service, multimedia format, greater accuracy reporting symptoms, timely information, accessibility, low cost, standardisation and increased user and supplier control of the intervention. Sensor technology and automated data collection enable passive monitoring of psychological states that can alert patients and healthcare providers to acute and chronic stress states [26]. These sensors can be used in monitoring patients, tracking daily activities, and caring for the chronic disease people or patients who have special states [27]. This information offers treatment that is evidence based from the information obtained from sensors and monitoring activities. All the applications of this technology culminated in increased comfort, convenience, and better management, thereby improving the quality of life. Table 1 shows the multiple advantages and disadvantages of Internet of Things-based healthcare monitoring and management of health system.
Explanation | Sources | ||
---|---|---|---|
Advantage | Monitoring | Remote patient monitoring continues to grow and help physicians diagnose and treat illnesses and diseases with obtaining reliable information with a negligible error rate. | [27, 28] |
Sensing | IoT with intelligent medical sensors will enhance the quality of life significantly and prevent the occurrence of health problems. | [22] | |
Low-cost solutions | Reduce unnecessary visits by doctors, and readmissions come from patients with chronic diseases and reduce testing cost. | [29] | |
Ubiquitous access | Allow and increase the accessibility from anywhere, any time and any media allowing flexibility and mobility to the users. Enable real-time access services to the healthcare provider to access patient information and help them to make better decisions. | [30] | |
Better quality of healthcare management | Increase the care quality and control by enhancing the management of drugs, reduce the medical error, enhance the patient experience, improve the disease management and improve outcome of treatment. | [31, 32] | |
Unified information | Automated data collection enabled from health information resources such as monitoring, first aid, tracking, analysis, diagnosis, alarm-triggering, locating and collaboration with medical healthcare under unified communication platform and exchanged the health record. | [27] | |
Time | This facilitates the interaction among the parts of an enterprise and allows for reducing the time necessary to adapt itself to the changes imposed by the market evolution. | [33] | |
Disadvantage | Complexity | The IoT is a diverse and complex network. There is a need of multiple services to grow device counts, massive increases of Internet bandwidth with a need to drive requirements for lower latency, greater determinism and processing closer to the edge of the network. Thus, any failure or bugs in the software or hardware will have serious consequences. Even power failure can cause a lot of trouble. | [34, 35] |
Compatibility | Although different manufacturers will be interconnected, the problem issue of compatibility when manufacturers do not agree to a common standard will make the people buy appliances from a certain manufacturer, leading to its monopoly in the market. | [23] | |
Security and privacy | A location tracking and collect inappropriately information for any person considering as a challenge in the using of IoT services in the healthcare system. The patient concern of attacks his personal identity and privacy maybe arise. Therefore, bring big data from millions of things in a healthcare system can cause many security challenges. | [36, 37] | |
Massive health data | In IoT, devices assemble and communicate information directly with each other via Internet and the cloud manages to collect record and analyse data blocks. But the ‘things or devices’ which are producing a massive amount of data are blowing out day-to-day, which needs to be treated and managed. | [38, 39] |
The IoT advantages and disadvantages.
Many open challenges need to be addressed by new research and investigation, mostly due to the complex deployment characteristics of such systems and the stringent requirements imposed by various services wishing to make use of such complex systems. Thus, it becomes critically important to study how the current approaches to standardisation in this area can be improved and at the same time better understand the opportunities for the research community to contribute to the IoT field [36]. In addition, many other technologies and devices such as barcodes, smart phones, social networks, and cloud computing are being used to form an extensive network for supporting IoT [12, 23] (as shown in Figure 3).
Technologies associated with IoT [
The healthcare applications and system have adopted several types of innovation technologies/devices in order to enhance the performance of healthcare services delivered. Most of these systems and applications are contributing to use IoT or smart technology devices to perform better advantage in healthcare services. These IoT applications and healthcare devices are called HIoT. The healthcare device implements dedicated sensor, and holds high collecting precision advantage, while it is also having a number of disadvantages such as insufficient portability, high cost and usability. This type of device possesses the following features:
Wearability: most of the HIoT applications offer sensing on the human body so they collect data exactly and take vital signs of the human body as collecting targets. Thus, most of the existing medical health devices make the wearability as the basic requirement of collection of human body vital signs. On this vein, the users feel more comfortable and can be enhanced and the accuracy of the collected health data can be guaranteed through the collecting procedure. The layout of common human body sensors is shown in Figure 4.
Long working time: the ways of dedicated health collecting data are several for instance universal mobile devices, wearable devices, pedometer, etc. The purpose of these devices is to collect data from the human body for a relatively long time period that requires high power and capability.
Constancy or stability: HIoT has high ability to collect data very normally even though the users are under strenuous exercise or in an extreme environment.
Low participation degree of users: the functionality of HIoT applications and devices are relatively independent, as well as most HIoT devices do not require the intervention of users during the collecting data procedure. In addition, the users need to start up the power source only, and the HIoT device will start collecting data.
Possessing data interim storage mechanism: the dimensions and weight of HIoT maybe limited strictly in order to meet the wearable feature. Thus, most HIoT devices do not integrate the data transmission module, but can select the data storage module with relatively small dimensions and adopt the data interim storage mechanism in order to store the collected data in advance, and then transmit the data through other network access devices accurately.
Layout of common human body sensors.
Using IoT can improve and modify the delivered healthcare services in the following aspects:
Relying on sensing-based screening and assessment technologies in home and community environments can reduce the physical pressure on the environment of hospitals and turn this information into an electronic flow of information.
Changing the medication process from a reactive model to a proactive and preventative model can significantly minimise the hospital admission expenses for acute events.
Improving the personalisation of healthcare processes allows individuals to monitor and identify their risk factors, seek preventative intervention and treatment and live independently. In this way, personalising healthcare processes has a significant positive impact on the psychological and physiological states of patients.
Improving the management of clinical workloads can allow healthcare systems to effectively prioritise those patients who have the highest need for medical services.
Supporting self-care diagnostic processes for monitoring vital signs and other various measurements can produce data that are shared with physicians either personally or by phone in order for them to make effective diagnoses. These diagnoses can sometimes be automated for simple illnesses, such as flu.
Point-of-care tests can be optimised by reducing the time of diagnosis, which in turn can be achieved by reducing the requirements for sending samples to be tested. For example, automatic testing by using blood pressure cuffs and digital thermometers can help physicians review the history of their patients while performing the necessary measurements. Among its practical advantages, IoT can encourage the development of smart systems that support and improve biomedical and healthcare processes. Monitoring the physiological parameters of patients in real time can also facilitate the early detection of clinical deterioration, automatic people identification and tracking by using biomedical devices in smart hospitals and monitoring drug-patient associations [40].
Figure 5 illustrates the IoT scenario in smart hospitals. A patient with an emergency case is given a wearable device that detects the nearest ED that offers the required services. Upon being notified of an emergency case, the ED dispatches an ambulance to the location of the patient and delivers the necessary care services. Upon its arrival, the ambulance links the bio-bank of patient information to a secure cloud that stores the EHRs, laboratory test results and medical and prescription histories of the patient. This process can help health practitioners understand the status of their patients quickly, easily and effectively.
IoT in the healthcare scenario.
IoT in HIE systems is mostly designed to store, enter, receive and exchange health information. This system increases the number of devices and enhances the mobility of information to support health professionals in their consultations. Despite the benefits of using IoT in hospitals, several challenges related to availability, reliability, mobility, performance, management scalability, interoperability, security and privacy must be considered during its application [41].
Collecting and exchanging health information have become challenging due to the increasing population and demands for health services. These challenges can hinder the successful adoption of HIE. The following issues and challenges related to HIE adoption have been identified from the literature:
Unified patients’ data: this challenge refers to the combination of patient’s data that are obtained from EHR systems that are being operated by healthcare providers (e.g. aged care providers, hospitals and healthcare specialists) for the purpose of sharing information. The unification of patient data provides excellent opportunities in continuing care, improving care quality and analysing and monitoring care service delivery and patient health outcomes.
Teamwork of care: teamwork refers to collaboration among healthcare practitioners with the shared aim of exchanging information [42]. The communication deficiency among groups of healthcare professionals, departments or clinics has been identified as the main driver of critical safety incidents in tertiary care clinics. However, with the growing complexity of healthcare provision, the availability of patient information has been considered highly significant in the healthcare industry. Therefore, teamwork places less effort in promoting the availability of information. A survey of primary care doctors from 10 countries identified the overall communication, coordination of healthcare and teamwork as common challenges in HIE adoption. The lack of integration among primary care, specialty care and hospitals can also put patients at risk and lead to duplicative care, particularly for those patients suffering from complex chronic illnesses [43]. The full potential of teamwork is seldom realised due to training problems and the lack of trust in the reliability of healthcare services. Physicians are also often blamed for the errors that may occur during the provision of these services.
Security and privacy: due to security and privacy concerns [44, 45, 46], many physicians and healthcare providers prefer to store patient records on computers or local systems that are not connected to the Internet [47]. Despite the benefits of large-scale HIE, a comparative study of the medical record exchange practices in Australia, Canada Germany, Netherlands, New Zealand, the UK and the US [48] revealed that Germany lacks a single approach for HIE and that healthcare software companies have achieved minimal success in their development of infrastructures where physicians can exchange clinical data due to security concerns. Similar to other countries, the substantial privacy and security concerns in the UK and the Netherlands have driven the resistance of healthcare professionals to HIE despite the benefits of this practice.
Address shortage: another important issue that hinders the adoption of HIE is the storage of health information in a single pool. Cloud computing or other related technologies may be used as storage to allow healthcare practitioners to access and utilise health information at any time and place. Storing information online emerges as the most popular choice even though most users have expressed their concerns about storing their personal information on the Internet. In addition, the collected data must be managed and comply with standard formats and protocols in order for them to be retrieved and used by other healthcare providers. However, a common standard protocol for these data is yet to be devised [45]. Furthermore, patients should be allowed to access to their own data and be given the right to dispose of these data freely and ensure that their information is kept secure.
Patient consent: the success of HIE also depends on public support, the willingness of patients to share their health information and their consent to have their health information shared with other parties via HIE [49, 50]. A study that examined the attitudes of patients towards giving consent revealed that the majority (91%) of the participating adult patients expect to be asked for their consent before their identifiable records are accessed and used for health provision, research or planning while only 9.2% of these respondents do not expect to be asked for their consent [51].
Compatibility: compatibility refers to the degree to which the potential adopters perceive innovation as consistent with their values, previous experiences and needs. Therefore, based on physicians’ expectations, the HIE system should be compatible with their work style and needs to motivate them to adopt such technology. This issue has a significant effect on the usage of innovation to promote HIE among hospitals [52].
Hospital workflow: Healthcare professionals need to transform the HIE system to satisfy their demand for a faster access to patient information, which in turn can reduce their workflow. Issues related to workflow are important barriers that prevent the implementation of technologies in some health practices. Physicians in practices without EMR are generally reluctant to use computers to write prescriptions because these technologies are unavailable in many examination rooms. Therefore, HIE must promote consistency in workflows by facilitating staff training to improve their efficiency and by providing clinical information with minimal effort at any time or location [53, 54].
System capacity: in order to facilitate HIE, the systems being used in hospitals should be effective and sustainable. Zhang et al. [15] attributed the limitation of system capacity to the following causes:
The failure to implement tecihnological advancements in most hospitals and the need to upgrade the HIE system to improve its capability.
The delayed development of a standard-compliant HIE system in many hospitals.
The overlapping functions among the needs of several regions, which reduce the need for information exchange.
However, exchanging patient records, including summaries and test results, among healthcare practitioners is not yet considered a norm in many countries. In the US, New Zealand and Canada, the current capacity of healthcare practitioners to share health information only ranges between 14 and 55% [43, 55]. With the technological advancements in networking, EHRs can be accessed by using various devices and stored in remote data centres.
To further understand the current utilisation of IoT in the healthcare sector, the related models/frameworks are reviewed as follows:
Given the increasing demand of health organisations for access to patient records around the world, Tyagi et al. developed a cloud IoT-based healthcare framework and proposed
Cloud-IoT-based healthcare framework [
Actors in the cloud-IoT-based healthcare framework [
Collecting data from things, devices and multiple sources presents a significant problem. Patients can be classified into those patients who are having elective treatment and those emergency patients who require immediate treatment [57]. Those elective patients who do not require emergency treatment may experience health deterioration and eventually require emergency treatment or tests. A hospital setting is characterised by dynamic uncertainty and a frequent need to dynamically change the treatment pathway. Manate et al. proposed the intelligent context-aware decision support (ICADS) system, which provides an effective basis for rescheduling and prioritising essential services while maximising the effectiveness of the staff in knowing the health status of their patients, planning emergency treatment requirements and providing quality care. Even though this system can produce exciting benefits for the stakeholders of the healthcare industry, several complexities and challenges in hospital settings need to be addressed before implementing ICADS [31]. Figure 8 summarises this system.
Model of a typical ICADS [
Many mobile health applications are still operating offline and are yet to be integrated into the semantic Web technologies for e-Health services [58]. Moreover, a unified rationale for developing healthcare development applications and middleware solutions is lacking. Therefore, users must build generic IoT applications to combine several domains. Datta et al. proposed the machine-to-machine (M3) framework, which enables the provision of smart, connected and personalised healthcare and wellness services to people living in smart homes [59]. This framework involves the use of wearable devices that collect patient data, which are then transmitted to smartphones that act as intermediate gateways. These data are then transmitted to remote cloud Web interfaces to maintain end-to-end security. The cloud computing platform is mainly targeted to manage patient data. However, this method does not allow patients to receive a high-level abstraction of the data collected by wearable devices [58]. Figure 9 summarises this framework.
Operational flow of the M3 framework [
Prayoga and Abraham iteratively tested, applied, refined and validated the behavioural intention in technology acceptance model (TAM) as one of the most prominent models used in Greater Jakarta to identify those variables that could predict the intention of individuals to utilise IoT health devices and integrate them into a theoretical model [60]. They analysed technology acceptance from the perspective of TAM and used perceived usefulness as the main predictor of behavioural intention. They also proposed a theoretical model to outline some important predictors of the behavioural intention of individuals to use IoT health devices. They performed a questionnaire survey among 186 college students from different faculties to test the hypothesised relationships between factors. As shown in the survey results, 91% of the respondents agreed that health trackers can help them achieve their personal health goals, 89% believed that these devices can change their health patterns and 90% thought that these devices will revolutionise healthcare systems. Although 87% of these respondents had searched for health-related information online while 35% had heard about such technology, only 13% of them had actually used health trackers [60]. Figure 10 summarises the IoT behavioural intention model.
IoT behavioural intention model [
Roy et al. proposed a model that facilitates the adoption of IoT-based innovations in urban poor communities [21]. This model identifies five sources of innovation, namely, nutrition, healthcare, employment, education and finances. They also argued that IoT can positively affect the urban poor by providing them access to various types of services, including healthcare, education and food security. Their study was conducted in four stages, including a literature review, a survey of the target users, interviews with experts and a usability test of a prototype technology system. They assumed that the implemented system needs to provide quality service to its users and that users should experience tangible benefits and receive some training. These factors can help service providers deliver excellent services to their consumers and subsequently drive a higher consumer satisfaction [21]. This model is summarised in Figure 11.
Model of IoT-based innovations for the urban poor [
Jagatheesan et al. argued that multiple sensors with various applications from each manufacturer are easily configurable yet are generally not preferred by their users [61]. Therefore, they proposed the multiple producer multiple consumer (MPMC) network that aggregates human interfaces to allow users to control any part of the data distribution framework. This framework includes a scenario where IoT-based multiple sensors are used as producers of data and multiple IoT services are used as consumers of these data. Their findings highlighted how the experiences and perspectives of users affect the data framework design in MPMC environments by using the drop data framework infrastructure. However, this network does not serve the needs of IoT users, and service providers are unable to choose among multiple options and the security or actual data transfer protocols are usually lacking [61]. The MPMC framework is illustrated in Figure 12.
MPMC framework [
The researchers investigated a case of a diabetic patient in an emergency situation [29]. They proposed the IoT communication framework as the main enabler of distributed worldwide healthcare applications. The main actors in this model include the monitored patients, physicians and distributed information databases. Their findings contribute to the actual implementation of a comprehensive healthcare system within IoT. They also highlighted the importance of using different devices, networks and processes in analysing diabetes progression. However, this framework is not yet completely available, the components presented in the use case are at different stages of realisation and the proposed framework does not integrate runtime sensing information into healthcare records [29]. This model is summarised in Figures 13 and 14.
IoT e-Health system model [
IoT e-Health process model [
Manashty et al. aimed to fill the gap between symptoms and diagnosis trend data in order to predict health anomalies accurately and quickly [62]. Not one of the existing systems can act as a bridge between different systems to facilitate knowledge transfer and to enhance their detection and prediction capabilities. These systems are also unable to use the data and knowledge provided by similar systems due to the complexity involved in the data sharing process. Storing information also presents a challenge due to the high volume of data generated by each sensor. Therefore, Manashty et al. proposed the healthcare event aggregation lab (HEAL) model, a platform that provides services to developers and leverages the previously processed data and the corresponding detected symptoms. The proposed architecture is cloud-based and provides services for input sensors, IoT devices and context providers. The HEAL platform is an integrated system for high-level behaviour monitoring that supports many users and systems in their long-term analysis, thereby bridging the gap among many systems. However, Manashty et al. did not perform multiple case studies to evaluate the performance of the proposed system in complex heterogeneous scenarios with knowledge sharing [62]. This model is summarised in Figure 15.
Cloud-based HEAL platform model [
Sheriff et al. proposed a reference framework for healthcare informatics and analytics by integrating IoT, complex event processing (CEP) and big data analytics [63]. This framework can serve as a reference in implementing a holistic healthcare informatics and analytics ecosystem. Integrating IoT, CEP and big data analytics technologies can solve specific problems. Specifically, CEP can support the real-time and near-real-time analytical processing of patient events from different sources by using big data and ubiquitous communication via IoT. In the future, Sheriff et al. are planning to use this framework as a foundation for developing a healthcare application system that can address the informatics and analytic needs of healthcare and other dependent industries. However, they did not test the performance of this framework [63]. This framework is illustrated in Figure 16.
Reference framework [
Pir et al. developed the HMIS framework with context awareness for developing the management systems of smart hospitals based on IoT [64]. They introduced context awareness as a middleware of the IoT architecture to overcome the problems in large data management. This framework consists of three layers, including a physical layer, network layer and application layer. The physical layer, also known as the perception layer, collects data and communicates them to the network layer. The network layer then processes and transmits these data to the application layer. Context awareness, which is located above the network layer as middleware, analyses the data and transfers only the required data to the application layer. Afterwards, the application layer defines the context of the data based on the problems faced by users when interacting with the system. However, Pir et al. did not test the applicability of this framework for users from a specific hospital [64]. Their proposed HMIS framework is presented in Figure 17.
HMIS framework [
Chatterjee and Armentano identified several issues, such as the availability of a live data connection and the security structure of a system, which prompted them to develop a system for a smart medical environment that provides ubiquitous services [10]. Specifically, they proposed a model with an inclusive approach for applying IoT in a smart medical environment that provides ubiquitous services. This model virtually stores patient data and makes them ubiquitously accessible to the concerned healthcare personnel in order to be shared. Another important aspect of using these data lies in the design of an intelligent clinical decision support system that can help doctors when delivering treatment. However, Chatterjee and Armentano failed to address the requirements for adopting IoT and only focused on the inclusion of technologies in the healthcare sector, thereby limiting the generalisability of the factors that they proposed for different types of hospitals in various countries [10]. The schematic diagram of their IoT-based remote treatment model is summarised in Figure 18.
Schematic diagram of the IoT-based remote treatment model [
Gupta et al. examined the design and implementation of an IoT-based health monitoring system for emergency medical services [65]. This system demonstrates the flexible collection, integration and interoperation of IoT data that can provide support to emergency medical services. Their proposed model allows users to improve health-related risks and reduce healthcare costs by collecting, recording, analysing and sharing large amounts of data in real time. This system uses smart sensors that collect and send raw data to a database server where they are further analysed and statistically maintained to be used by medical experts. The results are deployed and tested on a patient whose personal details are inputted into a Web portal. This patient is then connected to a health monitoring system that includes a heart rate sensor and a temperature sensor. However, Gupta et al. did not consider in their work some factors in the organisational and system domain as identified in the literature review. They also did not consider the actual examination of healthcare professionals [65]. The proposed health monitoring system is illustrated in Figure 19.
IoT-based smart healthcare kit model [
The aforementioned models/framework for IoT use in healthcare can be classified based on the technological, system and individual aspects as summarised in Table 2.
Source | Technological | System | Individual | Context |
---|---|---|---|---|
[56] | x | Healthcare-based cloud computing network | ||
[31] | x | Intelligent support system in hospitals | ||
[58] | x | x | Healthcare in smart homes | |
[60] | x | x | Behaviour of using IoT health devices | |
[21] | x | Use of IoT in urban poor communities | ||
[61] | x | Controlling via a human interface system | ||
[24] | x | Monitoring via smartphones | ||
[62] | x | Knowledge-based healthcare system | ||
[29] | x | Healthcare application process | ||
[63] | x | x | Healthcare informatics and analytics | |
[64] | x | x | Context awareness | |
[10] | x | Remote treatment | ||
[65] | x | Healthcare monitoring |
Models/frameworks for IoT use in healthcare.
In sum, most studies on IoT use in healthcare have some limitations related to their context of use, antecedents of implementation and need of use. Moreover, these studies have only focused on specific domains to achieve certain needs for using IoT in the healthcare context. Their models/frameworks are only designed for certain circumstances and environments related to the context and needs for which they are developed. Meanwhile, very few researchers have examined the actual implementation of IoT in hospitals. Therefore, further study must be conducted to generalise the application of these frameworks for hospitals. The literature review shows that the direct effect of technological and system-related factors on the utilisation behaviour of individuals has received no to limited input from previous research. The limitations of the aforementioned frameworks/models are summarised in Table 3.
No. | Source | Limitation |
---|---|---|
1 | [29] | Requires the availability of several elements, including interoperability, reliability, privacy, authentication and integrity for exchanging EHRs across the network. |
2 | [31] | The system should identify the patients’ conditions and notify the responsible staff who then review if the case of a patient needs to be treated as an emergency case depending on the information collected by sensors. Hospitals are facing several challenges in their implementation of IoT that should be acknowledged when designing an ICADS system. |
3 | [58] | This model focuses on smart home healthcare and the data collected from individuals must be managed and stored by decision makers in hospitals. |
4 | [61] | This study did not examine the requirements of IoT users and some issues related to data security transfer protocols. |
5 | [63] | This framework only focuses on the health information scenario and ignores those critical issues and challenges that may be faced by healthcare professionals. |
6 | [56] | Despite offering the benefits of trust and privacy to healthcare providers, several issues related to security remain unaddressed. This model needs to improve its security and test its results. |
7 | [60] | Model behavioural intention has been tested, applied, refined and validated many times in TAM to identify those variables that can predict the intention of individuals to use IoT health devices and integrate them into a theoretical model. |
8 | [21] | This model focuses on the use of IoT in urban poor communities, which is not considered part of a healthcare context. |
9 | [24] | This model focuses on the collection and uploading of health data by using smartphones as part of personal monitoring. The full utilisation of IoT has not been taken in consideration in this model. |
10 | [62] | Multiple case studies are not performed to assess the performance of the actual system in complex heterogeneous scenarios with knowledge sharing. |
11 | [64] | These results may satisfy certain hospitals in which no testing is performed in order to address the issues that they are facing. |
12 | [10] | This model only focuses on the inclusion of technologies in the health sector. Moreover, no experimental study has been performed, thereby limiting the generalisability of the proposed factors for different types of hospitals in various countries. |
13 | [65] | Those factors identified in the previous literature have not been considered and no actual examination of healthcare professionals has been performed. |
Limitations of models/frameworks for IoT use in healthcare.
IoT use has become an urgent need for public hospitals and their technical and management activities. A successful IoT use is influenced by how well this technology fulfils the expectations of its users. The implementers of this technology must identify the implementation requirements from the management’s perspective and align the implementation with the goals of hospitals in order to ensure a successful implementation and utilisation. Table 3 shows that most studies on IoT use in healthcare have some limitations related to their identified factors as well as their context and purpose of use. These factors are also limited to certain developed and developing countries. In addition, the actual use of IoT in HIE has never been reviewed in the literature.
Specifically, some models and frameworks have been designed only for specific contexts, circumstances and environments. Meanwhile, other scholars have merely proposed models/frameworks without any post examination or evaluation, thereby making these models/frameworks unsuitable for examining IoT use in HIE for different reasons. These studies also do not focus on the HIE context and ignore the organisational, technological and individual aspects. Some of the proposed models have merely focused on security and privacy concerns and ignored all the other aspects related to organisational and technological issues. Very few studies have examined e-Health and m-Health architectures that use smartphone sensors and wearable devices to sense and transmit important patient data.
As a summary, this chapter shows that a model/framework specifically for IoT use in HIE is yet to be developed and that only few studies have examined the use of IoT in this type of exchange. However, most of the extant studies have identified HIE as a huge challenge for most countries and that the HIE among healthcare providers is very limited at present.
This study was motivated by the gaps in the literature and several issues related to HIE, including the limited capabilities of clinical centres and the perceived need for early detection. Another concern related to the interoperability of various smart electronic devices has also been raised. The findings presented in this chapter offer a foundation for future work on this topic. Proposing a process or framework may also be considered in future research from the perspectives of healthcare providers and management to offer solutions for the development of successful IoT services in the health sector.
This finding offers a foundation for further researchers in several ways. The success factors and proposed IoT implementation process identified and revealed in this study may be considered in future research from perspectives of healthcare providers and management, and thus offer a solution to develop successful IoT services in the health sector.
About 7% of the population >65 years suffer from a painful heel, even though younger people are often affected, too [1]. The most common cause of this symptom is the so‐called “plantar fasciitis” [2]. This term is widely used, although “plantar fasciopathy” or “plantar fasciosis” would be a better description to point out the degenerative nature of the disease. However, as more than 1100 citations in Pubmed quote “plantar fasciitis” (in comparison with only 50), we will use the traditional term in the following.
Plantar fasciitis has been associated with obesity, with acute or chronic work overload, or with work on hard surfaces [2, 3]. It seems that physiological degeneration of the fascia at the calcaneal insertion exacerbates due to repetitive microtraumas caused by vertical compression [4]. This causes inflammatory tissue reactions. As a result, the fascia is thickened with an associated fluid collection to 4.0 mm and more in ultrasonography [5]. Furthermore, this inflammation may trigger bone formation, the so‐called “plantar heel spur.” This process has been studied intensively by Kumai and Benjamin [6]. They proposed three stages of spur growth: “(a) an initial formation of cartilage cell clusters and fissures at the plantar fascia enthesis; (b) thickening of the subchondral bone plate at the enthesis as small spurs form; and (c) development of vertically oriented trabeculae buttressing the proximal end of larger spurs” [6]. The first description of this spur formation and correlation with the clinical symptoms was carried out by Plettner in 1900 [7]. However, not every heel spur is associated with heel pain, as these spurs are found in 11–16% of the normal asymptomatic population [4]. On the other hand, some patients with painful plantar fasciitis do not have a radiographic confirmation of a spur formation.
A similar mechanism (although caused by longitudinal traction and not by vertical compression) of bone formation has been described at the insertion of the Achilles tendon [8].
According to the American clinical practice guidelines from 2010, diagnosis is established by the typical anamnesis and the characteristic localizations of tenderness. Still, weight‐bearing radiographs are also recommended [9].
Single doses of external beam radiotherapy (EBRT) in the range of 0.3–1 Gy are called “low dose EBRT” (LD‐EBRT). These single fractions are applied two or three times a week until a total dose of about 3–6 Gy is reached. Such radiotherapeutic concepts are used for diverse nonmalignant conditions, e.g., osteoarthrosis, tendinopathy, epicondylitis, or bursitis. A comprehensive review of the historical developments in LD‐EBRT for benign diseases is given by Trott [10].
In contrast, EBRT in oncology is characterized by much higher single and total doses. “Normofractionation” describes single doses of 1.8–2 Gy, applied about five times a week. To treat breast cancer, the total doses of about 62 Gy are necessary, in prostate cancer even more than 72 Gy. From a radiobiological point of view, these high cumulative doses are used to induce DNA double strand breaks. Due to errors in a repair mechanism (nonhomologous end joining), dicentric chromosomes can occur. These can result in unfinished mitoses, the so‐called “mitotic catastrophe,” the main mechanism to reduce clonogenic survival in tumor cells [11]. High doses of EBRT induce local inflammation and tissue reactions.
The much lower doses of LD‐EBRT act via different mechanisms. In the last two decades, several anti‐inflammatory effects have been discovered, contrary to the effects of the above‐mentioned high EBRT doses.
Furthermore, doses between 0.1 and 0.5 Gy reduced the adhesion of PBMC significantly to endothelial cells (ECs)
A third mechanism was the suppression of nitric oxide (NO) production in activated macrophages by LD‐EBRT between 0.3 and 1.25 Gy [18]. As the expression of inducible nitric oxide synthases (iNOS) proteins was not altered, the LD‐EBRT seemed to act at the translational or posttranslational level. Furthermore, a dose of 0.5 Gy significantly reduced oxidative burst and superoxide production of stimulated macrophages [19]. A diminished release of reactive oxygen species (ROS) can also contribute to the anti‐inflammatory effects of LD‐EBRT.
Taken together, all of these pathways and mechanisms showed a similar dose dependence with a maximum effect between 0.3 and 0.7 Gy regarding a discontinuous dose‐effect relation [20].
There are several
Since 1937 [21] for decades, large retrospective studies on the efficacy of LD‐EBRT in calcaneodynia have been published (overview in 22). In 1970, one negative randomized trial was reported and heavily criticized but had not been repeated [23]. Starting in the 1980s, patients were systematically clinically examined and interrogated in a structured manner to try to control for diverse risk factors and to compare the efficacy of different fractionation schemes and total doses [24].
It took until the past decade to perform and report prospectively randomized trials to proof the efficacy of LD‐EBRT and to identify the optimal dose fractionation schedule. In the following, we report the design and the results of these trials. Table 1 gives a short overview of the studied dose concepts and the results. Due to methodological reasons, we will describe the studies not following their publications dates, but according to a systematic order.
Since the publication of the first randomized trial on LD-EBRT in 1970, the efficacy of LD‐EBRT was questioned [23]. Goldie et al. randomized 399 patients, however, only nine patients suffered from calcaneodynia. This is why these results cannot be extrapolated to LD‐EBRT of a painful heel spur. Furthermore, endpoints were not clearly defined, and therapy was started in an acute stage of the disease [25].
The landmark study to prove the efficacy of LD‐EBRT was performed by the German cooperative group on the radiotherapy for benign diseases (GCGBD) under the responsibility of Niewald et al. [26]. A very low dose EBRT (6 × 0.1 Gy applied twice a week up to a total dose of 0.6 Gy) was randomized to a standard dose LD‐EBRT (6 × 1 Gy twice a week up to a total dose of 6 Gy). In the case of an unfavorable response after 3 months, the patient was offered a second treatment series (“reirradiation”) applying a standard dose. The dosage of the experimental arm was chosen to examine if very low doses are effective at all. Second, it acted as a placebo irradiation, as a sham irradiation was regarded unethical. LD‐EBRT was applied using a linear accelerator (4‐ to 6‐MV photons) using lateral parallel opposing fields.
Inclusion criteria were tenderness of the calcaneus with a limitation of the painless walking distance and duration of the symptoms for more than 6 months. Furthermore, a radiological proof of a heel spur was required, and the patients had to be least 40 years of age. Patients with previous traumata to the foot, rheumatic or vascular diseases, lymphatic edema, pregnancy, or breastfeeding were excluded. Concomitant therapy with oral analgesics was not limited. However, local injections with steroids during the study period were not permitted.
Initially, 200 patients were planned [27] to detect a difference of 10% in the quality of life (QOL) sum score (SF‐12) [28] and calcaneodynia sum score (CS) [29] (Table 2) with a power of 80% and an error probability of 5%. Furthermore, the visual analogue scale (VAS) to evaluate pain intensity was used. However, after randomization of 66 patients and interim analysis of 62 patients (4 had to be excluded due to a withdrawal of informed consent or violation of the inclusion criteria), the differences in efficacy between the two treatment arms were so pronounced, that the trial was closed early.
Author | Year | N | Standard arm | Experimental arm | Results | Conclusions |
---|---|---|---|---|---|---|
2012 | 66 | 6 × 1 Gy twice a week | 6 × 0.1 Gy | 3 months: VAS/CS/SF12 sig. better with standard | 1. Dose‐response relationship | |
1 year: less second treatment series with standard | 2. Proof of therapeutic effect of LD‐EBRT | |||||
2007 | 130 | 6 × 1 Gy twice a week | 6 × 0.5 Gy | 6 months: CS no sig. differences | 6 × 0.5 Gy as standard fractionation | |
2014 | 457 | 6 × 1 Gy twice a week | 6 × 0.5 Gy | 6 weeks, 2.5 years: VAS/CS no sig. differences | 6 × 0.5 Gy as standard confirmed | |
2015 | 127 | 6 × 1 Gy twice a week | 12 × 0.5 Gy thrice a week | 3 months: VAS/CS/SF12 no sig. differences | Efficacy not increased with 12 × 0.5 Gy standard still 6 × 0.5 Gy |
Summary of contemporary randomized trials on LD‐EBRT of painful heel spurs: tested schedules, results, and conclusions.
Criteria | Extent of symptoms/alteration | Points |
---|---|---|
S = Pain at | 6 / 4 / 2 / 0 | |
(total: 30%) | N = Pain during D = Pain during R = Pain at I = Pain at none = 6 ; slight = 4 ; moderate = 2 ; severe = 0 points ⇨ | 6 / 4 / 2 / 0 6 / 4 / 2 / 0 6 / 4 / 2 / 0 6 / 4 / 2 / 0 |
per single criterion | ||
(total: 15%) | None Orthopedic shoe, insoles, heel cushion One cane or crutch Two canes or crutches ⇨ | 15 10 5 0 |
(total: 20%) | No limitation, maximum professional strain possible Slight limitation, normal professional work possible Moderate limitation, reduced professional activity Severe limitation, daily professional work impossible ⇨ | 20 10 5 0 |
(total: 15%) | No limitation of daily and leisure activities and sports Slightly limitation/reduced leisure activities and sports Moderate limitation/no leisure activities and sports Complete limitation of any daily and leisure activities ⇨ | 15 10 5 0 |
(total: 20%) | No limp, normal walking is possible without a limitation Slightly altered, limp after walking Moderately altered, limp after walking Severely altered, normal walking is impossible ⇨ | 20 10 5 0 |
The mean age of patients was 54 years in the standard dose group and 58 years in the 6 × 0.1 Gy group. Sixty‐one patients had a plantar, one patient a dorsal heel spur. In mean, patients in the standard dose group suffered for 15.3 months before the start of LD‐EBRT, in the 6 × 0.1 Gy group for 18.8 months. Twenty‐one patients had symptoms on both sides. In 28 patients the pain irradiated into the calf, only in 18 patients it was localized to the sole of the foot. Two patients had received surgery for LD‐EBRT.
Three months after therapy VAS values, CS‐ and QOL‐scores were significantly better after the standard dose in comparison with the very low dose treatment arm. The higher pain relief resulted in a better QOL. Twelve months after therapy about 64% of the patients after 6 × 0.1 Gy had to receive a second treatment series due to insufficient treatment results, in comparison with only 17% of the patients in the standard dose treatment group. As the second series was applied with a standard dose (6 × 1 Gy), patients in the 6 × 0.1 Gy group who were reirradiated showed equally favorable results compared with those in the standard‐dose group who did not receive a second course [26]. This is why the second treatment series in this clinical setting acted as a “salvage therapy.” Another interesting finding was that patients with a good response already at 3 months remained stable or even improved at 12 months. Furthermore, this underlines the long‐lasting efficacy of LD‐EBRT.
Acute side effects or long‐term toxicity did not occur.
In conclusion, this randomized trial established a dose‐response‐relationship of the analgesic effect of LD‐EBRT, thus providing a clinical and methodological proof of the efficacy of 6 × 1 Gy LD‐EBRT on the clinical course of painful heel spurs. The early termination of the study was justified due the interim analysis showing significant differences in the clinical outcome between both treatment arms. Still, the trial was not blinded, so both the patients and the staff were aware of the received dose. With modern linear accelerators, a complete blinding of the staff is nearly impossible. The only option would be a shame irradiation with closed collimator jaws, reducing the dose to the unavoidable “leakage” radiation. A much easier and straight forward way was used in the above‐mentioned study by application of a minimal physical dose with 0.1 Gy. Another critical point might be that only half of the patients were examined 12 months after therapy (
Another potential confounder not only in this study but also in all other published prospective and retrospective case series might be that a lot of the patients had received diverse and other conservative therapies before being referred to LD‐EBRT. An interaction between one of these other treatments and LD‐EBRT cannot be ruled out due to methodological reasons. This reflects clinical reality. Still, an interaction between one of these therapies and LD‐EBRT is rather unlikely and counter‐intuitive, as patients were referred to LD‐EBRT after the clinical failure of all the other conservative treatments.
Two randomized studies investigated the efficacy of 0.5 Gy single dose in comparison to 1 Gy.
The first trial was conducted by Heyd et al. [30]. They randomized 130 patients between 6 × 0.5 Gy twice weekly (low dose) and 6 × 1 Gy (standard dose). A linear accelerator was used, applying a single field technique.
Inclusion criteria were clinical signs of a painful heel spur, radiological evidence of spur formation, patient age ≥30 years and a relapse after previous conservative treatments, in patients >45 years LD‐EBRT could be used as the primary treatment. Endpoints of the study were changes in the “original” calcaneodynia score [31], that was documented before LD‐EBRT, at the end of the course, and 6 weeks and 6 months afterward.
One hundred and thirty patients were randomized. Mean age was 58.4 years. A 102 patients suffered from a plantar, one patient from a dorsal, and 27 patients from combined spurs. In mean, patients had been suffering from symptoms for 9.8 months. The symptoms had been present in 58 patients for less than 6 months, in 72 patients for a longer time. In 7 heels LD‐EBRT was the first therapeutic approach.
At the end of LD‐EBRT, 66% in the low dose group vs. 59% in the standard dose experienced an improvement in symptoms, 6 weeks later 80 vs. 85%. At this time point, 1.5% in each group reported an increase in symptoms, 19 vs. 14% no change. No statistically significant differences were noted. In case of insufficient treatment results patients were offered a second EBRT series. Thus 26 vs. 37% were treated a second time. Six weeks after that, 71 vs. 79% of these patients reported a further improvement. Six months after LD‐EBRT 88% of the patients in both groups had an amelioration of their symptoms, the remaining patients reported no change. During the EBRT series a slight increase in pain was reported by 26 vs. 29% of the patients. No other acute or late toxicity occurred.
In conclusion, 6 × 0.5 Gy twice weekly was as effective as 6 × 1 Gy.
These results were confirmed by a second randomized trial [32, 33]. Ott et al. randomized 457 patients between 6 × 0.5 Gy (low dose) and 6 × 1 Gy (standard dose). In contrast to the above‐cited “Heyd‐study” [30] an X‐ray unit (orthovoltage) and not linear accelerators was used. Patients received a single field (6 × 8 cm on the plantar calcaneus) with 150 kV, 15 mA, 1 mm Cu‐filter, with source‐to‐skin distance (SSD) of 40 cm. Six weeks after the LD‐EBRT a second series was offered to patients with an insufficient response. The endpoint was pain reduction. CS score and VAS values were measured before and at the end of LD‐EBRT (early response), 6 weeks (delayed), and 2.5 years (long‐term) afterward.
With a median follow‐up of 32 months the mean VAS values before treatment, for early, delayed, and long‐term response for the 0.5 and 1.0 Gy groups were 65.5 ± 22.1 and 64.0 ± 20.5 (
Taken together, the above‐mentioned studies proofed an equivalent clinical efficacy of 6 × 0.5 Gy in comparison to 6 × 1 Gy, thus defining a new clinical treatment standard with six times 0.5 Gy twice weekly as the minimum effective dose.
Before proofing 0.5 Gy as the new standard single dose, another randomized study tried to increase efficacy in reaching the “old” cumulative dose of 6 Gy with a single dose of 0.5 Gy. Niewald et al. randomized between 6 × 1 Gy twice a week (old “standard dose”) and 12 × 0.5 Gy three times a week (“experimental dose”) [25]. The aim was not just to get comparable results, but to further improve the analgesic effects. Linear accelerators (6 MV photons) applying a lateral opposing field technique were used.
Inclusion and exclusion criteria were quite similar to the ones used in the landmark study [26]: Clinical evidence of a painful heel spur, and duration of the symptoms for more than 6 months; radiological proof of a spur formation; age at least 40 years; Karnofsky‐Index at least 70%. Patients with previous radiotherapy or previous trauma to the foot, rheumatic or vascular diseases, lymphatic edema, pregnancy, breastfeeding, or severe psychiatric disorders were excluded. Concomitant therapy with analgesics was allowed. However, patients receiving surgery or shock wave therapy after randomization were excluded.
Endpoints were the SF‐12 sum score, the CS sum score (Table 2), and VAS. Follow‐up was scheduled every 6 weeks for 1 year.
Two‐hundred and forty patients were calculated to detect a difference of 15% in the VAS and CS score, with a power of 80%, and an error probability of 5%. After randomization of 127 patients and an interim analysis of 107 patients, the study was closed early, as the intended increase in analgesic efficacy by the experimental treatment was very unlikely to be achieved.
The mean age of the patients in the standard group was 56.1 Gy in comparison with 58.1 Gy in the experimental group. The mean duration of symptoms before initiation of LD‐EBRT was 17 vs. 16 months. In 98% of the standard group and 93% of the experimental group a plantar spur was treated, in 2 and 7% a combined (plantar and dorsal) spur.
Results after 3 months have been issued so far [25], longer follow‐up has yet to be published. After 3 months, there were no significant differences neither in the VAS (standard 42.3 vs. experimental 44.4) nor the CS sum score (28 vs. 28.4) nor in the QOL (SF‐12) scores. Although longer follow‐up has to be awaited, a further increase in the analgesic effect by applying 12 × 0.5 Gy three times a week is unlikely. This is why this fractionation schedule is currently not recommended, as it does not follow the “as low as reasonable achievable” principle of radiation protection.
Further reduced single doses in LD‐EBRT (with the exception of 0.1 Gy [26]) have never been tested in a prospectively randomized clinical trial. In radiotherapy of degenerative joint disorders, single doses of about 0.3–0.4 Gy were established by von Pannewitz in the late 1920s and published in 1933 and 1970 [34, 35]. However, two studies on calcaneodynia have raised serious concerns on single doses as low as 0.3 Gy.
Seegenschmiedt et al. analyzed treatment efficacy in 141 patients (170 irradiated heels), who were treated from 1984–1994 with X‐ray units (250 kV/200 kV, 20 mA, 40 cm SSD), applying a single field of 6 × 8 cm [24]. Seventy‐two heels received 12 Gy with 6 × 1 Gy (three times a week) –6 weeks break – 6 × 1 Gy (group A), 50 heels were treated with 10 × 0.3 Gy every day (group B1), and 38 heels 10 × 0.5 Gy every day (group B2). The endpoint was the value of a semiquantitative pain score 3 months and in mean 4 years after LD‐EBRT.
The median age of patients was 55 years in group A and 59 years in group B1/B2. The mean duration of symptoms before LD‐EBRT was 8 months, in one‐third, the symptoms persisted for more than 6 months.
Complete pain remission was achieved in 68–71% of the patients without significant differences between the treatment groups. However, there were differences in the clinical course of patients with partial remission of the symptoms: The best results in these patients were achieved during longer follow‐up in group B1 (10 × 0.5 Gy), followed by group A (6 × 1–6 × 1 Gy), followed by group B2 (10 × 0.3 Gy). The latter group showed a significantly worse amelioration of symptoms than the other groups.
A reduced efficacy was also reported in another retrospective case series, comprising 673 heels treated with a single dose of 0.3 Gy three times weekly up to 1.5 Gy (X‐ray) [36]. In case of insufficient treatment results the patients were offered a second course. After the first treatment, only 13% reported CR, nearly all patients had undergone a second LD‐EBRT.
Taken together, to the best of our current knowledge a single dose of 0.5 Gy is standard of care and should only be modified in controlled clinical trials.
In Table 3 selected contemporary randomized trials and patient series are shown broken down into several factors that might be correlated with treatment efficacy. For a better overview, we did not differentiate between univariate and multivariate analyses. We did not try to collect all ever published data.
Duration of symptoms before start of LD‐EBRT has been shown to be correlated with treatment efficacy in numerous studies.
Muecke et al. analyzed in a retrospective multicenter study 502 patients [22]. Duration of symptoms ≤6 months was associated with 76% treatment success vs. 44% after a history >6 months. Also Seegenschmiedt et al. found in their large collectives a correlation between the duration of heel pain and treatment outcome [24]. A significant influence of duration of symptoms before LD‐EBRT was also reported in 73 heels by Schneider et al. [37]. With a history of 3–6 months, the VAS value was reduced by 85%, 28 months after LD‐EBRT in comparison with a reduction of 58% with a history > 6 months. Similar results were obtained by Hermann et al. in 285 heels comparing <12 month history of pain vs. >12 months [38].
In contrary, another study could not confirm these results [30].
To the best of our knowledge, in no study, an influence of gender on treatment outcome has been confirmed [22, 24, 30, 38, 39]. In contrast to radiotherapy for oncological indications with high doses, efficacy and tolerability of LD‐EBRT seems to be the same concerning gender.
Several studies described a correlation between older age and better treatment results, at least 6 weeks after LD‐EBRT [37]. Age somewhat over 50 years seems to be important: >50 years [40], > 53 [38], or > 58 [22]. For a possible explanation see Section 2.3.7.
However, other studies found no influence of this patient characteristic on treatment outcome [24, 30, 39].
A very precise registration of changes in pain intensity (VAS) was done by Schneider at al. [37]. Sixty‐two patients (73 treated heels) were prospectively scored every week during LD‐EBRT, at the end of therapy, 6 weeks, 28 months, and 40 months later. Additionally, subjective mechanical heel stress during LD‐EBRT was estimated. A linear accelerator (10 MV) was used, applying one single field with a size of 12 × 17 cm. Patients were treated twice a week to a total dose of 5 Gy, with increasing single fraction doses (0.25 – 0.25 – 0.5 – 1 – 1 – 1 – 1 Gy). Mean patient age was 54 years, and all had a radiologically proven plantar spurn, mean symptom duration before LD‐EBRT was 6.5 months. Nearly all patients had received other conservative therapies before LD‐EBRT with insufficient results.
Interestingly, VAS scores decreased continuously during LD‐EBRT: before treatment the mean value was 6.3 ± 1.5, after the first week of LD‐EBRT 6.2 ± 1.8, after the second week 5.5 ± 2 (
In standard schedules with fixed single doses a slight increase in pain during the treatment series was reported by 26% (during 6 × 0.5 Gy) vs. 29% (6 × 1 Gy) of the patients [30]. Unfortunately, a possible correlation of this phenomenon with definite treatment results was not investigated.
Without further quantification, another study (6 × 1 vs. 6 × 0.1 Gy) stated, that this initial increase in symptoms “had no influence on the final pain relief 3 and 12 months after treatment” [26]. Older studies postulated a temporary reduction of the pH value in the irradiated tissues at the beginning of the treatment series, without consequences for the long‐term efficacy of LD‐EBRT [41].
This is contrasted by observations of LD‐EBRT in peritendinitis humeroscapularis [42]. In 73 patients (86 shoulders) initial increase of pain during the treatment course was significantly associated with a good response.
Muecke et al. analyzed in a retrospective multicenter study the influence of different treatment techniques in 502 patients [22]. Treatment failure was defined as pain persistence after LD‐EBRT and recurrence of pain during follow‐up. Treatment with MV (6–10 MV) was a significant prognostic factor for pain relief in multivariate analysis, as MV was associated with an eight‐year event‐free probability of 68 vs. 61% after X‐ray beams (175 kV). There are two possible explanations for this finding: besides the possibility of a random result, the authors postulate a more homogenous dose distribution with MV treatment in comparison with KV [22].
Schneider et al. reported an efficacy of just one‐third after a second LD‐EBRT course (so‐called “re‐irradiation”) in comparison with the effects of the first course [37]. Out of 73 heels treated with 5 Gy LD‐EBRT 18 heels received reirradiation due to insufficient treatment response. However, pain reduction measured by means of changes in VAS shortly after the second course and during long‐term follow‐up was significantly diminished in comparison with the efficacy of the first course (about 30% reduction in pain at the last evaluation vs. 86%).
Similar results were obtained in the large retrospective series (502 patients) by Muecke et al. [22]. Treatment failure was significantly associated with the number of treatment series: eight‐year event‐free probability was about 70% after the first course in comparison with just about 30% after reirradiation.
A systematic study on the efficacy of a reirradiation has been published by Hautmann et al. [43]. Eighty‐three patients (101 heels) with insufficient response to the first course or recurrent pain afterward due to plantar fasciitis (83 heels), or achillodynia (28 heels) received a second LD‐EBRT course in median 10 weeks (range 4 weeks to 63 months) after the first LD‐EBRT. About 75% of the patients were treated with 6 × 1 Gy, the others 6 × 0.5 Gy. The pain was assessed using the numeric rating scale (NRS) before and at the end of LD‐EBRT, 6, and 12 weeks, and 6, 12, and 24 months thereafter.
Before reirradiation NRS values were 6 (interquartile range 5–8), at the end of LD‐EBRT 5 (2–6), 6 weeks later 2 (1–4), at 12 weeks 1 (0–3), at 6 months 0 (0–2), at 12 and 24 months 0 (0–1). Interestingly, not only the patients with recurrent pain after the first course but also patients with insufficient responses to the first course experienced a profound and long‐lasting amelioration of their symptoms after the second course.
This is why a second treatment course should be recommended in case of insufficient efficacy of the first course.
A significant correlation between avoidance of heel stress during LD‐EBRT and efficacy of LD‐EBRT 6 weeks after therapy was reported by Schneider et al. in 73 heels [37]. With a Pearson\'s correlation coefficient of -0.467 (
An intuitive explanation is given by the authors [37]: As patient age was associated with positive treatment results, too, they proposed that older patients are often retired, thus being able to take more care of their heels.
Interestingly, all randomized trials required the radiological proof of a heel spur before including patients into the studies. Furthermore, most of the prospective and retrospective series warranted such an objective sign. However, as a substantial part of the patients suffers from plantar heel pain without having developed a heel spur, LD‐EBRT should be effective in these patients, too.
Hermann et al. analyzed treatment efficacy in 250 patients (285 heels), who received LD‐EBRT predominantly with 6 × 1 Gy [38]. In this series, 33% of the treated heels were without radiological evidence of a spur. In 185 patients a spur was confirmed with a mean length of 6.5 mm (range 0.6–25 mm). Patients without evidence of a plantar heel spur had a significantly higher chance of CR after LD‐EBRT (43 vs. 35%). Furthermore, the length of the spurs correlated directly with treatment outcome. Spurs >6.5 mm had just a 30% chance of experiencing CR in comparison with shorter ones. No statistical differences were found between treatment results of heels without spurs and those with spurs ≤6.5 mm.
Miszczyk et al. reported on 327 patients (623 LD‐EBRT series) mostly treated with X‐ray (180 kV, usually 1mm Cu filters) with single doses of 1.5 Gy (range 1–3 Gy) up to a total dose between 9 and 12 Gy (range 1–45 Gy) [39]. Mean spur size was 9 mm (range 1–30 mm). With a mean follow‐up of 74 months, no correlation between spur size and duration of pain relief was found. Analysis concerning spur length and treatment outcome in itself were unfortunately not reported.
Multivariate logistic regression enables the identification of factors independently predicting treatment outcome. By combining these factors, models can be calculated, that predict treatment outcome with a high probability. An example from the study of Hermann et al. is given in Table 4: in 285 heels treated with 6 × 1 Gy/6 × 0.5 Gy the influences of the patient characteristics age, spur length, and duration of symptoms before LD-EBRT alone and in combination were calculated [38]. The best results were obtained for patients > 53 years, spur length <6 mm, and a duration of symptoms <12 months with a probability for CR of 55% (CI 36–73%) and PR of 38% (CI 22–58%). Without these characteristics, the chance for CR was just 18% (CI 9–33%), for PR 31% (17–48%).
Study (citation) | [30] | [26] | [24] | [37] | [39] | [22] | [38] | [40] | [83] |
---|---|---|---|---|---|---|---|---|---|
Rand | Rand | Prospect | Prospect | Retrospect | Retrospect | Retrospect | Retrospect | Retrospect | |
130 | 66 | 170 | 73 | 623 | 502 | 285 | 161 | 7947 | |
MV | MV | KV | MV | KV | MV, KV | MV | KV | MV, KV | |
calcaneus | calcaneus | calcaneus | entire dorsal and middle foot | insertion of plantar fascia | calcaneus | calcaneus vs. insertion of calcaneus | calcaneus | entire dorsal foot vs. calcaneus vs. insertion of plantar fascia | |
6 × 1 vs. 6 × 0.5 Gy | 6 × 1 Gy vs. 6 × 0.1 Gy | 12, 3, 5 Gy | 5 Gy (increasing single dose) | 1.5 (1–3) up to 9–12 Gy (1–45) | 5–10 × 0.5–1 Gy | 6 × 1 Gy6 × 0.5 Gy | 6 × 1 Gy | 0.3–1.5 Gy; 2–3x weekly 2.5–18.76 Gy | |
History of symptoms | 0 | n.i. | + | + | 0 | + | + | + | + |
Gender | 0 | n.i. | 0 | n.i. | 0 | 0 | 0 | n.i. | n.i. |
Patient\'s age | 0 | n.i. | 0 | + | 0 | + | + | + | n.i. |
Initial worsening of pain during LD‐EBRT | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. | n.i. |
MV vs. KV | n.i. | n.i. | n.i. | n.i. | n.i. | + | n.i. | n.i. | 0 |
Number of therapy series | n.i. | n.i. | n.i. | + | n.i. | + | n.i. | n.i. | + |
Heel stress during LD‐EBRT | n.i. | 0 | n.i. | + | n.i. | n.i. | n.i. | n.i. | n.i. |
Factors associated with treatment efficacy in contemporary studies.
Patient\'s age >53 | No spur or spur ≤6.5 mm | Duration of symptoms <12 months | Probability of | ||
---|---|---|---|---|---|
No change | Partial remission | Complete remission | |||
1 | 1 | 1 | 0.07 (0.03–0.14) | 0.38 (0.22–0.58) | 0.55 (0.36–0.73) |
1 | 1 | 0 | 0.13 (0.07–0.28) | 0.37 (0.21–0.57) | 0.50 (0.30–0.70) |
1 | 0 | 1 | 0.15 (0.06–0.24) | 0.53 (0.33–0.72) | 0.32 (0.17–0.53) |
1 | 0 | 0 | 0.25 (0.13–0.45) | 0.48 (0.27–0.69) | 0.27 (0.13–0.48) |
0 | 1 | 1 | 0.17 (0.10–0.31) | 0.33 (0.19–0.50) | 0.50 (0.33–0.66) |
0 | 1 | 0 | 0.34 (0.20–0.53) | 0.40 (0.24–0.59) | 0.26 (0.13–0.45) |
0 | 0 | 1 | 0.30 (0.20–0.46) | 0.29 (0.18–0.43) | 0.41 (0.27–0.56) |
0 | 0 | 0 | 0.51 (0.35–0.69) | 0.31 (0.17–0.48) | 0.18 (0.09–0.33) |
Probabilities (95%‐CI) for NC, PR and CR calculated by polytomous logistic regression in dependence of the risk factors age, spur length, and duration of symptoms before LD‐EBRT according to Hermann et al. in a collective of 285 heels treated with 6 × 1/6 × 0.5 Gy (taken from [38]).
In modern radiotherapeutic departments, X‐ray sources are less and less available. This is why nowadays most patients are treated with linear accelerators, which were initially developed for the treatment of oncological diseases. However, these machines can be used in the treatment of benign diseases without any modifications or problems. Due to the high efforts in physical, technical, and organizational quality assurances for the operation of an accelerator or an X-ray source, the concentration on accelerators and their use for all indications is recommended.
For irradiation of the heel, the patient has to be placed on the treatment couch with the feet toward the gantry of the accelerator (so‐called “feet first”). Two different patient positions are widely used. He can be placed in supine position, with the irradiated leg is stretched out, while the other leg is angled. Another option is to place the patient in a lateral decubitus position on the side of the involved heel. Again, the symptomatic leg is stretched, while the contralateral leg is bent, with a cushion placed beneath the knee. Using X‐rays, the ipsilateral knee is bent by 90% and the foot is positioned on the treatment table. One anterior‐posterior (AP) beam is usually applied in this technique.
For the treatment itself, there are also two different options. Irradiation may be given as a single stationary field (SSD 100cm by convention). Alternatively, parallel opposing fields from 0° and 180° gantry position (in decubitus position) or lateral opposing fields (90° and 270° in supine position) are also applicable but take a little bit longer in daily clinical practice. The hypothetical advantage of using two opposing fields is a uniform dose distribution in the entire beam path in the calcaneus (Figure 1). However, there has never been a clinical proof, whether this theoretical assumption translates into any clinical advantage for the patient. When applying opposing fields, the dose is specified according to the ICRU 50 report, normally in the center of the calcaneus.
Dose distribution of two different treatment techniques generated in a treatment planning system (XIO®). In A and B just one single 6 MV photon field (8 × 8 cm) is applied, while C and D shows the dose distribution with two opposing fields from 0 and 180°. In the upper row, the so‐called “beams eye views” are given, while in the lower row the respective dose distributions on an axial CT scan directly at the calcaneal insertion are shown. Note the more uniform dose distribution with opposing fields. The 95% isodose is given as a green line (2.85 Gy). This dose encompasses larger parts of the calcaneal bone in D (opposing fields) than in B (single field). More information is given in Section 2.4.
A third option is the so‐called “plantar field” with the patient lying in prone position. A single field is positioned directly over the plantar insertion/calcaneus, potentially with rotations of the patient table and the gantry to compensate for inclinations of the patients surface in the irradiated field. However, this technique is regarded problematic when using linear accelerators due to the dose build‐up effect in the critical tissue depth. This problem is illustrated in Figure 2: photons with 6 MV reach just the half of the prescribed dose at the skin level, 100% is reached at 1.5 cm tissue depth. This would result in an insufficient dose in the critical structures (plantar fascia and heel spur). To overcome this problem, a silicone flap of about 1 cm diameter must be positioned on the skin before radiation.
Depth curves of different megavoltage energies. Blue 6 MV photons, red 15 MV photons. At the surface of the body/skin (depth 0 mm), only half (or even less with 15 MV) of the prescribed dose is applied. By physical interactions between photons and the tissue/water, there is a steep increase in dose. A 100% is reached at 1.5 cm depth with 6 MV and at about 3 cm depth with 15 MV. KV‐radiation reaches the maximum dose directly under the surface/skin (not shown). More information is given in Section 2.4.
Patients are often sent to the radiotherapist after a long unsuccessful history of diverse conservative treatments. The reason for this is a widespread fear among general practitioners that LD‐EBRT might be associated with severe side effects and risks. These fears are not substantiated, as reactions of the nerves or vessels require much higher doses than used for LD‐EBRT. For example, a dose of 45 Gy in normofractionated oncological therapy is considered to be safe for the spinal cord and therefore daily clinical practice [44]. Peripheral nerves are even more radioresistant. Acute or chronic side‐effects have never been reported in all contemporary studies on LD‐EBRT.
Acute side effects are negligible, as very low doses of ionizing radiation (in comparison with oncological treatments) are applied to a distal extremity. The total dose of LD‐EBRT with 3 or 6 Gy is far too low to cause any acute or late reactions on the skin overlaying the calcaneus. During normofractionated EBRT (single doses of 1.8–2 Gy, treatment on 5 days a week) erythema and mild edema develop at about 30 Gy [45]. Hyperpigmentation occurs at about 45 Gy, moist epitheliolyses at about 50 Gy. A 50–60 Gy might cause telangiectasias years after the therapy. This is why there is no report on acute treatment side effects in LD‐EBRT until now to the best of our knowledge.
About one‐third of the patients might experience a slight increase in pain during LD‐EBRT. In the randomized trial by Heydt et al. this phenomenon was seen in 26% (during 6 × 0.5 Gy) vs. 29% (6 × 1 Gy) [30]. It does not seem to be correlated with treatment outcome; further detailed information is given in Section 2.3.4.
The dose scattered to the male gonads is somewhat higher than to the ovaries. Jansen et al. calculated for 6 × 0.5 Gy about 1.5 mSv received by the testes and 0.75 mSv to the ovaries [46]. Comparable results have repeatedly been measured in the past [47, 48].
Taken together, the dose received by the gonads is insignificant. As the distal extremity is irradiated, scattered dose to the gonads is comparable to normal diagnostic radiological imaging [49]. The hereditary effects of these doses are very small and very likely negligible [46].
Although spermatogonial cells are very radiosensitive, a single dose of at least 100 mSv is needed to induce a temporary failure of spermatogenesis [50]. A single dose of 1000 mSv (equivalent to 1 Gy photon irradiation) results in an azoospermia for 9–18 months [51]. Interestingly, fractionated doses harm these cells even more. A temporary oligospermia is reported after receiving several fractions up to a cumulative dose of 160 mSv [52]. An azoospermia lasting for 14–22 months has been reported for fractionated doses of 620–860 mSv [53]. The actually during LD‐EBRT received testicular dose is about 100 times smaller than the lowest dose causing temporary changes in testicular tissues.
The dose to the testicles can be further reduced by utilizing a special testicular shielding. However, clinically meaningful dose reductions have been only measured in MV treatment of subdiaphragmatic/pelvine lymphatic regions or tumors [54, 55].
The mean lethal dose for human oocytes has been estimated at 2 Gy (2000 mSv) [56]. Permanent ovarian failure after radiotherapy is age dependent: in perimenopausal women, a dose of 6 Gy is sufficient [57], while in younger women up to 20 Gy are tolerated. The dose scattered to the ovaries during LD‐EBRT for calcaneodynia cannot cause such sequelae (0.75 mSv).
Naturally, pregnancy has to be excluded in all premenopausal women before beginning with LD‐EBRT, to avoid any risk to the fetus.
So far, no studies with long‐term observation periods have been published, describing a case of malignancy induced by LD‐EBRT for calcaneodynia. However, induction of malignancies is a stochastic effect of ionizing radiation. This means that there is no threshold dose—in contrast for example to the above‐mentioned reactions of the skin. A photon can accidentally trigger a mutation, which in turn leads to tumor formation many years later. The higher the radiation dose, the higher the probability of such an event occurring.
The best available data on tumor induction of full dose EBRT in oncology has been collected in patients treated with breast cancer. Almost 11,000 patients have been followed for over 20 years. The risk of a radiation‐induced tumor was approx. 1% per decade after radiotherapy [58].
To estimate the risk associated with much lower doses of LD‐EBRT, mathematical models on the basis of epidemiological long‐term observations of atomic bomb victims have been developed by the ICRP [59].
Jansen et al. applied the ICRP model on LD‐EBRT of a painful heel spur [46]. Assumed was a single field entering at the foot sole with a size of 8 × 10 cm, 200 kV photons, SSD 40 cm. For an LD‐EBRT series with 6 × 1 Gy the average attributable lifetime risk for induction of a fatal tumor was calculated to be about 0.5 in a thousand patients. An important risk factor for radiogenic‐induced cancer is the patient\'s age by the time the radiation exposure occurs. The risk is already reduced in the 3rd decade of the patient\'s life, it starts to decrease steadily from the age of 40 [60]. Applying these calculations, the estimated lifetime risk per one thousand patients for a fatal tumor accounts for the age of 25 0.6 (male)/0.8 (female), for the age of 50 0.2/0.3, for the age of 75 0.07/0.1 [46].
However, it must be critically noted that this mathematical model was developed for radiation protection and relates to the exposure of complete organ systems with approx. 1 Gy. Therefore, other groups argue that a significantly lower risk of radiogenic cancer induction— approx. ten times less—should be adopted [49, 61]. Furthermore, taken the new standard scheme with 6 × 0.5 Gy into account, these risks are additionally halved.
This risk (max. 1/1000, very likely much lower) must be seen in relation to the tumor risk of the not additionally radiotherapeutical‐treated population. In 2008, the lifetime risk of a man in Germany to suffer from cancer was 50.7% (25.9% to die from malignancy), in women 42.8% and 20.2% respectively [62].
By limiting the application of LD‐EBRT treatment to patients > 30 years of age, an exposure of the juvenile “relatively higher risk” patient population is avoided.
Traditionally target volume definition has been quite large. Field sizes of 12 × 17cm were treated, including the entire dorsal and middle foot, and not just the calcaneus [37, 82] (Figure 3A).
Field definitions in LD‐EBRT of a painful plantar heel spur/fasciitis. (A) traditional field definition including the entire dorsal and middle foot. (B) In randomized trials and large prospective series commonly used field definition encompassing the entire calcaneus, including insertion of the plantar fascia and the Achilles tendon. (C) Proposed small field definition for localized painful plantar fasciitis/plantar spur, encompassing only the painful area with 2 cm margins extending into the neighboring areas (calcaneus, fascia, fat pad).
In the recent randomized trials and prospective observational studies target volume definition was more restricted and confined to the calcaneus (Figure 3B). “The target volume consisted of the calcaneus and the region of the plantar aponeurosis” [26]. “The ventral margin is corresponding to the ventral surface of the calcaneus, the plantar and dorsal margins are surrounding the soft‐tissue border, and the cranial margin is below the ankle” [30]. “Target volume is the calcaneus, normally with a field size of 6 cm × 8 cm” [32]. “The calcaneus and the plantar aponeurosis were included in the target volume” [25].
In a German national survey 2001 on LD‐EBRT of painful heel spurs the target volume definition “large” (dorsal and middle foot) vs. “small” (entire calcaneus) was not correlated with treatment outcome [83]. Consequently, very large field definitions should be regarded as obsolete.
However, as the pathophysiological cause of calcaneodynia is thought to be a localized inflammatory process (see Section 1), it is questionable, whether the entire calcaneus has to be irradiated (as long as there are not a plantar as well as a painful dorsal spurs). There are some clinical data that support a further restriction of target volume definition.
Field sizes have been given in the study by Miszczyk et al. on 327 patients treated with X‐ray beams [39]. Target volume was “… the insertion of the plantar fascia with a calcaneal spur and a reasonable margin. The field size varied from 27 to 150 cm2 (mean 47 cm2).” However, although not explicitly stated, no correlation was found between field size and duration of pain relief after LD‐EBRT. Treatment efficacy in itself was apparently not investigated.
In the above‐mentioned series of 285 heels Hermann et al. analyzed treatment efficacy in dependence of field sizes, too [38]. The mean field size was 74 cm2. No correlation between field size (smaller vs. larger than 74 cm2) with treatment efficacy was found. Further analyses of small fields (< 6 × 6 cm), medium‐sized fields (36–64 cm2) and larger fields revealed no significant differences.
This is why it seems to suffice to encompass the painful region with 2 cm margins extending into the neighboring areas (calcaneus, fascia, fat pad; Figure 3C). However, this recommendation is deducted from pathophysiological considerations and the above‐mentioned case series. A randomized trial is necessary to proof clinical equivalence of a field definition “entire calcaneus” (Figure 3B) vs. “insertion of the plantar fascia” (Figure 3C).
The optimal fractionation schedule has not been elucidated yet. All randomized trial used twice weekly treatments. Only one experimental arm was scheduled three times a week [25]. In a National Survey in Germany with 146 answering institutions, about 45% applied two fractions and 37.5% three fractions weekly [83].
Interestingly, in the landmark study by von Pannewitz a fractionation schedule of only once per week was established [34]. Until now, there is no proof of a higher efficacy applying LD‐EBRT twice or three times per week.
In radiotherapy of another benign disease (endocrine orbitopathy) a 1 Gy per week over 20 weeks schedule was more effective than the standard schedules (10 × 2 Gy or 10 × 1 Gy every working day) [84]. Although other immunological mechanisms cause endocrine orbitopathy in comparison with plantar fasciitis, there is sufficient clinical evidence to test in a randomized trial different fractionation schedules (twice a week vs. once a week, possibly thrice a week).
Other therapies than LD‐EBRT have been applied in painful heel spur. In the following, just a rough overview can be given.
Different kinds of insoles and foot orthoses have been developed. The goal was to reduce plantar contact pressure and to distribute the pressure uniformly over the whole rearfoot [63]. Magnetic insoles do not seem to provide additional benefit [64]. As a short‐term treatment, low‐Dye taping techniques are often used. However, in a randomized trial only a modest improvement in ‘first‐step’ pain was seen in comparison with sham‐intervention [65].
Manual stretching is often recommended. A systematic review of six studies found only statistically significant differences in comparison with the control in one study combining calf muscle and plantar fascia stretches [66].
Several trials have investigated acupuncture. A systematic review from 2010 showed (limited) evidence for the effectiveness [67]. A randomized trial published in 2014 recruited 84 patients [68]. The authors concluded, that “dry needling provided statistically significant reductions in plantar heel pain, but the magnitude of this effect should be considered against the frequency of minor transitory adverse events.”
Ultrasound therapy has led to questionable results [69], but a randomized trial on cryo‐ultrasound with about 100 patients published in 2014 showed good effectiveness [70].
Low‐level laser light (635 nm), given twice a week for a total of six applications, reduced in a randomized trial VAS scores significantly after 8 weeks in comparison with placebo [71]. However, the study comprised of just 69 patients; other similar studies have not been reported so far.
Extracorporeal shock waves are widely applied. Three metaanalyses comprising at least five randomized trials found significant short‐term pain relief and improved functional outcomes for this therapeutic option [72–74]. Another study compared the analgesic efficacy of ultrasound and shock wave therapy in 47 patients [75]. The results suggested that the shock wave therapy had greater analgesic efficacy.
Another basic approach is the oral administration of nonsteroidal anti‐inflammatory drugs (NSAID) to achieve a symptomatic relief. Injections into the painful area are also recommended. A recent review summarized ten randomized trials on corticosteroid injections into the plantar fascia [76]. A significant effect of the steroids on the pain has been shown. However, it was usually short‐term, lasting 4–12 weeks in duration. No advantage of ultrasound‐guided injection techniques in comparison with palpation guidance was found, and no superiority of one type of corticosteroid over another was seen. A longer lasting pain relief has been suggested by a small randomized trial of botulinum toxin injections [77]. Another option is the injection of autologous platelet‐rich plasma. A recent review identified three randomized trials, all showing promising results [78]. However, a very small trial challenged this method of plasma preparation, as the same clinical effectivity was observed after the injection of whole blood [79].
Different surgical approaches have been developed. Releases of the plantar fascia are done, in some studies combined with a spur resection [80]. Due to a probably faster recovery after surgery with comparable functional results endoscopic procedures are recommended nowadays [81]. Surgery is usually indicated after failure of conservative therapies as the ultimate “salvage‐therapy.”
There is only a limited amount of studies randomizing patients between LD‐EBRT and the above‐mentioned alternative therapies.
Canyilmaz et al. randomized 123 patients between LD‐EBRT (6 × 1 Gy, three times a week) and 1 ml injection of 40 mg methylprednisolone and 0.5 ml 60 mg 1% lidocaine under the guidance of palpation [85]. After 3 and 6 months, VAS values and CS‐scores were compared between both groups. After 3 months, the results in the radiotherapy arm were significantly superior compared with those after injections.
To corroborate these findings, similar studies should be conducted. Furthermore, more studies randomizing LD‐EBRT against other therapies (e.g. extracorporeal shock waves) are needed. A minimum size of 50 patients per treatment arm should be assured to gain more statistically relevant results. Recruiting patients without prior excessive other therapies for these studies would be optimal.
The goal must be an evidence‐based algorithm defining the therapeutic sequence of the different conservative treatment modalities for plantar fasciitis.
LD‐EBRT for painful plantar fasciitis/heel spur is an effective and safe treatment option for patients over 30 years of age and after exclusion of pregnancy. A fractionation of 6 × 0.5 Gy twice weekly up to a total dose of 3 Gy is currently recommended. In the case of an insufficient response a second course can be offered to the patient.
Randomized trials on target volume definition and further optimization of LD‐EBRT fractionation are currently in the process of planning. Further trials to compare the different conservative therapies for plantar fasciitis with each other are necessary to allow the development of an evidence‐based treatment algorithm.
This chapter is dedicated to Professor Gisela Hermann‐Brennecke on the occasion of her 70th birthday.
AP | anterior‐posterior |
CI | confidence interval |
CR | complete remission |
CS | Calcaneodynia score |
Cu | chemical element symbol for copper |
EC | endothelial cells |
GCG‐BD | German Cooperative Group on Radiotherapy for Benign Diseases |
Gy | Gray |
ICRP | International Commission on Radiological Protection |
IL | interleukin |
iNOS | inducible nitric oxide synthases |
KV | kilovoltage |
LD‐EBRT | low dose external beam radiotherapy |
mA | milliampere |
mRNA | messenger ribonuclein acid |
mSv | milliSievert |
MV | megavoltage |
NC | no change |
NF‐κB | nuclear factor kappa B |
NO | nitric oxide |
NSAID | non‐steroidal anti‐inflammatory drug |
PBMC | peripheral blood mononuclear cells |
PR | partial remission |
QOL | quality of life |
ROS | reactive oxygen species |
SSD | skin‐to‐source distance |
TGF‐β1 | transforming growth factor β1 |
VAS | visual analogue scale |
The Internet has irrevocably changed the dynamics of scholarly communication and publishing. Consequently, we find it necessary to indicate, unambiguously, our definition of what we consider to be a published scientific work.
",metaTitle:"Prior Publication Policy",metaDescription:"Prior Publication Policy",metaKeywords:null,canonicalURL:"/page/prior-publication-policy",contentRaw:'[{"type":"htmlEditorComponent","content":"A significant number of working papers, early drafts, and similar work in progress are openly shared online between members of the scientific community. It has become common to announce one’s own research on a personal website or a blog to gather comments and suggestions from other researchers. Such works and online postings are, indeed, published in the sense that they are made publicly available. However, this does not mean that if submitted for publication by IntechOpen they are not original works. We differentiate between reviewed and non-reviewed works when determining whether a work is original and has been published in a scholarly sense or not.
\\n\\nThe significance of Peer Review cannot be overstated when it comes to defining, in our terms, what constitutes a published scientific work. Peer Review is widely considered to be the cornerstone of modern publishing processes and the key value-adding contribution to a scholarly manuscript that a publisher can make.
\\n\\nOther than the issue of originality, research misconduct is another major issue that all publishers have to address. IntechOpen’s Retraction & Correction Policy and various publication ethics guidelines identify both redundant publication and (self)plagiarism to fall within the definition of research misconduct, thus constituting grounds for rejection or the issue of a Retraction if the work has already been published.
\\n\\nIn order to facilitate the tracking of a manuscript’s publishing history and its development from its earliest draft to the manuscript submitted, we encourage Authors to disclose any instances of a manuscript’s prior publication, whether it be through a conference presentation, a newspaper article, a working paper publicly available in a repository or a blog post.
\\n\\nA note to the Academic Editor containing detailed information about a submitted manuscript’s previous public availability is the preferred means of reporting prior publication. This helps us determine if there are any earlier versions of a manuscript that should be disclosed to our readers or if any of those earlier versions should be cited and listed in a manuscript’s references.
\\n\\nSome basic information about the editorial treatment of different varieties of prior publication is laid out below:
\\n\\n1. CONFERENCE PAPERS & PRESENTATIONS
\\n\\nGiven that conference papers and presentations generally pass through some sort of peer or editorial review, we consider them to be published in the accepted scholarly sense, particularly if they are published as a part of conference proceedings.
\\n\\nAll submitted manuscripts originating from a previously published conference paper must contain at least 50% of new original content to be accepted for review and considered for publication.
\\n\\nAuthors are required to report any links their manuscript might have with their earlier conference papers and presentations in a note to the Academic Editor, as well as in the manuscript itself. Additionally, Authors should obtain any necessary permissions from the publisher of their conference paper if copyright transfer occurred during the publishing process. Failure to do so may prevent Us from publishing an otherwise worthy work.
\\n\\n2. NEWSPAPER & MAGAZINE ARTICLES
\\n\\nNewspaper and magazine articles usually do not pass through any extensive peer or editorial review and we do not consider them to be published in the scholarly sense. Articles appearing in newspapers and magazines rarely possess the depth and structure characteristic of scholarly articles.
\\n\\nSubmitted manuscripts stemming from a previous newspaper or magazine article will be accepted for review and considered for publication. However, Authors are strongly advised to report any such publication in an accompanying note to the External Editor.
\\n\\nAs with the conference papers and presentations, Authors should obtain any necessary permissions from the newspaper or magazine that published the work, and indicate that they have done so in a note to the External Editor.
\\n\\n3. GREY LITERATURE
\\n\\nWhite papers, working papers, technical reports and all other forms of papers which fall within the scope of the ‘Luxembourg definition’ of grey literature do not pass through any extensive peer or editorial review and we do not consider them to be published in the scholarly sense.
\\n\\nAlthough such papers are regularly made publicly available via personal websites and institutional repositories, their general purpose is to gather comments and feedback from Authors’ colleagues in order to further improve a manuscript intended for future publication.
\\n\\nWhen submitting their work, Authors are required to disclose the existence of any publicly available earlier drafts in a note to the Academic Editor. In cases where earlier drafts of the submitted version of the manuscript are publicly available, any overlap between the versions will generally not be considered an instance of self-plagiarism.
\\n\\n4. SOCIAL MEDIA, BLOG & MESSAGE BOARD POSTINGS
\\n\\nWe feel that social media, blogs and message boards are generally used with the same intention as grey literature, to formulate ideas for a manuscript and gather early feedback from like-minded researchers in order to improve a particular piece of work before submitting it for publication. Therefore, we do not consider such internet postings to be publication in the scholarly sense.
\\n\\nNevertheless, Authors are encouraged to disclose the existence of any internet postings in which they outline and describe their research or posted passages of their manuscripts in a note to the Academic Editor. Please note that we will not strictly enforce this request in the same way that we would instructions we consider to be part of our conditions of acceptance for publication. We understand that it may be difficult to keep track of all one’s internet postings in which the researcher´s current work might be mentioned.
\\n\\nIn cases where there is any overlap between the Author´s submitted manuscript and related internet postings, we will generally not consider it to be an instance of self-plagiarism. This also holds true for any co-Author as well.
\\n\\nFor more information on this policy please contact permissions@intechopen.com.
\\n\\nPolicy last updated: 2017-03-20
\\n"}]'},components:[{type:"htmlEditorComponent",content:'A significant number of working papers, early drafts, and similar work in progress are openly shared online between members of the scientific community. It has become common to announce one’s own research on a personal website or a blog to gather comments and suggestions from other researchers. Such works and online postings are, indeed, published in the sense that they are made publicly available. However, this does not mean that if submitted for publication by IntechOpen they are not original works. We differentiate between reviewed and non-reviewed works when determining whether a work is original and has been published in a scholarly sense or not.
\n\nThe significance of Peer Review cannot be overstated when it comes to defining, in our terms, what constitutes a published scientific work. Peer Review is widely considered to be the cornerstone of modern publishing processes and the key value-adding contribution to a scholarly manuscript that a publisher can make.
\n\nOther than the issue of originality, research misconduct is another major issue that all publishers have to address. IntechOpen’s Retraction & Correction Policy and various publication ethics guidelines identify both redundant publication and (self)plagiarism to fall within the definition of research misconduct, thus constituting grounds for rejection or the issue of a Retraction if the work has already been published.
\n\nIn order to facilitate the tracking of a manuscript’s publishing history and its development from its earliest draft to the manuscript submitted, we encourage Authors to disclose any instances of a manuscript’s prior publication, whether it be through a conference presentation, a newspaper article, a working paper publicly available in a repository or a blog post.
\n\nA note to the Academic Editor containing detailed information about a submitted manuscript’s previous public availability is the preferred means of reporting prior publication. This helps us determine if there are any earlier versions of a manuscript that should be disclosed to our readers or if any of those earlier versions should be cited and listed in a manuscript’s references.
\n\nSome basic information about the editorial treatment of different varieties of prior publication is laid out below:
\n\n1. CONFERENCE PAPERS & PRESENTATIONS
\n\nGiven that conference papers and presentations generally pass through some sort of peer or editorial review, we consider them to be published in the accepted scholarly sense, particularly if they are published as a part of conference proceedings.
\n\nAll submitted manuscripts originating from a previously published conference paper must contain at least 50% of new original content to be accepted for review and considered for publication.
\n\nAuthors are required to report any links their manuscript might have with their earlier conference papers and presentations in a note to the Academic Editor, as well as in the manuscript itself. Additionally, Authors should obtain any necessary permissions from the publisher of their conference paper if copyright transfer occurred during the publishing process. Failure to do so may prevent Us from publishing an otherwise worthy work.
\n\n2. NEWSPAPER & MAGAZINE ARTICLES
\n\nNewspaper and magazine articles usually do not pass through any extensive peer or editorial review and we do not consider them to be published in the scholarly sense. Articles appearing in newspapers and magazines rarely possess the depth and structure characteristic of scholarly articles.
\n\nSubmitted manuscripts stemming from a previous newspaper or magazine article will be accepted for review and considered for publication. However, Authors are strongly advised to report any such publication in an accompanying note to the External Editor.
\n\nAs with the conference papers and presentations, Authors should obtain any necessary permissions from the newspaper or magazine that published the work, and indicate that they have done so in a note to the External Editor.
\n\n3. GREY LITERATURE
\n\nWhite papers, working papers, technical reports and all other forms of papers which fall within the scope of the ‘Luxembourg definition’ of grey literature do not pass through any extensive peer or editorial review and we do not consider them to be published in the scholarly sense.
\n\nAlthough such papers are regularly made publicly available via personal websites and institutional repositories, their general purpose is to gather comments and feedback from Authors’ colleagues in order to further improve a manuscript intended for future publication.
\n\nWhen submitting their work, Authors are required to disclose the existence of any publicly available earlier drafts in a note to the Academic Editor. In cases where earlier drafts of the submitted version of the manuscript are publicly available, any overlap between the versions will generally not be considered an instance of self-plagiarism.
\n\n4. SOCIAL MEDIA, BLOG & MESSAGE BOARD POSTINGS
\n\nWe feel that social media, blogs and message boards are generally used with the same intention as grey literature, to formulate ideas for a manuscript and gather early feedback from like-minded researchers in order to improve a particular piece of work before submitting it for publication. Therefore, we do not consider such internet postings to be publication in the scholarly sense.
\n\nNevertheless, Authors are encouraged to disclose the existence of any internet postings in which they outline and describe their research or posted passages of their manuscripts in a note to the Academic Editor. Please note that we will not strictly enforce this request in the same way that we would instructions we consider to be part of our conditions of acceptance for publication. We understand that it may be difficult to keep track of all one’s internet postings in which the researcher´s current work might be mentioned.
\n\nIn cases where there is any overlap between the Author´s submitted manuscript and related internet postings, we will generally not consider it to be an instance of self-plagiarism. This also holds true for any co-Author as well.
\n\nFor more information on this policy please contact permissions@intechopen.com.
\n\nPolicy last updated: 2017-03-20
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After finishing his P. hD degree in 1992, he served in the Industry as a Scientific Officer and continued his academic career as a visiting scholar for a number of educational institutions. In 1996 he joined National University of Science & Technology Pakistan (NUST) as an Associate Professor; NUST is one of the top few universities in Pakistan. In 1999 he joined an International Company Lineo Inc, Canada as Manager Compiler Group, where he headed the group for developing Compiler Tool Chain and Porting of Operating Systems for the BLACKfin processor. The processor development was a joint venture by Intel and Analog Devices. In 2002 Lineo Inc., was taken over by another company, so he joined Aalborg University Denmark as an Assistant Professor.\nProfessor Akbar has truly a multi-disciplined career and he continued his legacy and making progress in many areas of his interests both in teaching and research. 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