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This proposal seeks to address the issue of diabetic neuropathy among patients aged between 30 and 60 years. All the targeted patients suffer from the problem of refractory leg pain. The proposal suggests PEMF (Pulse electromagnetic field therapy) as an intervention Plan for treatment of diabetic patients who have a low carbohydrate-diet, and those who are on hypoglycemic oral medications or insulin therapy. The intervention method is also proposed for those patients who are on pain medication. In the experiment, patients with no PEMF therapy and a diagnosis of diabetic neuropathy are compared to those with refractory pain having analgesics, tricyclics, antidepressants, and anti-seizure medication.
The outcome of the research is expected to indicate whether the PEMF procedure could be helpful to patients with leg complaints including paresthesia, numbness, and tingling. The experiment will be carried out for one year. PEMF is a non-invasive therapy that is used to improve the outcome of neuropathy in diabetic patients. Also, it stimulates electromagnetic forces thereby quickening healing, improving circulation, and reducing muscular spasm. This research project aims to find out PEMFs mechanism of action, as it has been the subject of misunderstandings in the past.
Background and Significance of the Problem
The pulsed electromagnetic therapy (PET) is a technique that involves repetitive exposure of electromagnetic waves to patients ailing from non-union fractures, failed fusions, congenital pseudoarthrosis, neuropathic pain, and depression (Pawluk, 2011, p. 1). The technique is useful when treating patients with diabetic neuropathy to achieve pain reduction. The following research study attempts to uncover whether PET can be employed to mitigate pain, especially in the case of refracted-pain in diabetic neuropathic patients. Diabetic neuropathy is a disease that has raised concern because it is primarily a complication of uncontrolled diabetes mellitus. Aslam, Singh, and Rajbhandari (2014), note that the condition involves damage to the blood vessels supplying the nerves resulting in loss of feeling and stimulation in the affected organ. Therefore, proper prevention and treatment techniques should be enacted to decrease neuropathy.
Statement of the Problem and Purpose of the Study
One of the most complicated problems in diabetic neuropathy is refractory pain in the lower extremities, particularly the feet. Sometimes nurses do not focus on treating this pain when managing diabetic patients. Physicians observations, scholarly articles, and testimonies from recovering patients indicate that neuropathy-associated pain is immense and it should not be ignored (Pawluk, 2011). This research paper aims to uncover ways in which the pain may be treated by first finding out its prognosis and then looking at the possibility of employing Pulsed Electromagnetic Fields in treating the refraction pain on the lower extremities (Javed, Petropoulos, Alam, & Malik, 2015).
Literature Review
All the sources that are presented in this review are based on randomized control trials and peer-reviewed literature. They cover a wide variety of topics ranging from pathogenesis to current medication treatments of diabetic neuropathy. Also, this literature-review covers some experiments and randomized control trials that utilize PEMF coils. These sources support the research directly and indirectly by providing data that backs up the effectiveness of PEMF treatment in diabetic neuropathy.
Pathogenesis of Painful Diabetic Neuropathy
This research article provides insights into the mechanisms of painful diabetic neuropathy. According to the article, painful diabetic neuropathy is the most common cause of neuropathic pain around the world (Aslam et al., 2014). The study covers statistics for diabetic neuropathy for patients around the world and focuses on mechanisms of pain. The research addresses the physiology of pain, neuropathic pain generation pathogenesis, central sensitization, central inhibition, the role of dorsal root ganglion, sympathetic modulation of pain, and other points of interest. The article concludes that the current mechanisms of diagnosing the root of the problem are not very efficient.
This article is useful to the research as it provides a deeper understanding of the mechanisms of painful diabetic neuropathy, a topic that relates to the purpose of this study directly. Besides, the article indirectly supports the proposed research by stating that current diagnosing mechanisms are inefficient, thereby pointing to the fact that prescribing specific drugs to deal with diabetic pain is ineffective (Aslam et al., 2014). The material that is provided in this study is reliable and relatively recent.
Treatment of Painful Diabetic Neuropathy
Another article by a group of researchers reflects on the current methods of treatment for painful diabetic neuropathy (PDN). In the study that was conducted in 2015, the authors evaluate which drugs are considered the most potent in the treatment of PDN (Javed et al., 2015). This research reaffirms the view that objectively assessing PDN is difficult, which is why drugs are required to cover a wide array of possible causes of pain thereby making precise interventions impossible.
This article is important to the research as it provides insights into the modern pharmacological treatment of PND and reflects on its effectiveness. It also supports the use of PEMF by citing other studies that also claim that electromagnetic pulses are very effective in diminishing pain. The article was written and released in 2015, therefore making the study a recent and reliable source. The research is also based on randomized control trials and peer-reviewed literature.
Drugs for Neuropathic Pain
This study provides an excellent overview of the drugs that are currently in use for the treatment of neuropathic pain. Unlike the previous article, which provided an overview of all kinds of treatments, both pharmacological and non-pharmacological, this study focused on reviewing the effectiveness, side effects, costs, safety, and mechanisms of the drugs that are currently in use (Kalso, Aldington, & Moore, 2014). The study points out numerous drugs that could be used to address neuropathic pain. This article corroborates the previous source and supports the choice of antidepressants and opioids as some of the most efficient ways of treating pain.
The article is valuable to the research due to its insights on the pros and cons of the current medical treatments. It covers all of the side effects that may appear in a patient due to drug treatments. The study also assesses the effectiveness of pain treatment, thereby providing a point of comparison for non-invasive PEMF therapy procedures. The article was deemed a credible source as was is taken from a peer-reviewed medical journal and was written by acknowledged researchers in the medical field.
Therapeutic Effects of 15 Hz Pulsed Electromagnetic Field
This experiment was conducted by a group of Chinese specialists and published in the Plos One electronic journal in 2013. This study assesses the effectiveness of PEMF therapy on streptozotocin-treated rats. The research was meant to help eliminate some of the controversies surrounding PEMF by providing evidence for therapeutic effects on PEMF and then justifying its applicability to clinical practice (Lei et al., 2013). According to the experiment, PEMF therapy managed to reduce the sensitivity in the rat towards non-noxious physical and thermal stimuli.
Furthermore, the procedure aided in the reversal of the abnormalities that are associated with diabetic neuropathy and helped to reduce the bodyweight that is often associated with the disease. Besides, PEMF was proven to have a corrective effect on damaged nerves. The results of the experiment are very important to this research, as they provide physical proof of the effectiveness of PEMF. While previous articles supported the idea indirectly or without going into detail, this experiment provided solid support for this studys hypothesis.
Pulsed Electromagnetic Fields: How They Heal
This article was written by William Pawluk, a doctor who is known for his studies on the creation of an authoritative informational source on PEMFs. In this paper, the researcher covers the basics behind PEMF therapy by explaining the mechanisms of its interaction with the body (Pawluk, 2011). This study provides basic facts and information about PEMF therapy, its uses, side effects, and applications in healthcare. The information in this article is introductory as it acquaints the reader with the concept before moving on to more complicated subjects. The author of this source is a certified medical specialist, and this fact lends credibility to his statements. Also, the information he provides coincides with what is found in other reviewed sources.
Pulsed Electromagnetic Field Therapy with Mark II Coil for Diabetic Neuropathy
In this experiment, Shealy (2015) used different frequency PEMFs, ranging from 1 Hz to 72 Hz, which were applied to the skin, muscles, and brain. The device emitting the electromagnetic pulse was a Mark II Coil. It emitted an electromagnetic pulse to a patients feet, chest, and neck. The results of the experiments were remarkable because after 8 weeks of therapy the patients conditions improved by a factor of over 50% (Shealy, 2015).
This research is crucial to the current study as it provides great evidence to support the application of PEMF therapy in diabetic neuropathy treatment. Nevertheless, the impressive results that are shown in this research warrant further investigations. This experiment is supported by numerous studies and it was conducted roughly a year ago, making it a credible and recent peer-reviewed article.
Electromagnetic Fields in the Treatment of Wound: A Review of Current Techniques and Future Perspective
This study was performed by Ali Yadollahpour and Mostafa Jalilifar and posted in the Journal of Pure and Applied Microbiology in 2014. The research states that PEMF therapy has a promising effect in the treatment of different wounds, such as ulcers, and in dealing with pain in post-operational treatments. This research covers strategies of wound healing, the biological effect of electric fields, and quality/quantity measures of wound healing assessments (Yadollahpour & Jalilifar, 2014). The study concluded that PEMF therapy has a positive effect on wound treatment. These findings are important to our research because diabetes often causes ulcers, which serve as additional sources of pain. The research was conducted by two leading specialists of Ahvaz Jundishapur University of Medical Sciences and later published in a peer-reviewed medical journal. The paper is also a credible, reliable, and recent source of information.
Research Questions, Hypothesis, and Variables
This will be the main research question: In patients between the age of 30 and 60, how effective is PEMF in diabetic neuropathy when compared to other forms of treatment such as analgesics, tricyclics, antidepressants, and anti-seizure medication, when reducing symptoms and pain? The major hypothesis that can be formulated from this study is that: for neuropathy, PEMF is as effective as analgesics, tricyclics, antidepressants, and anti-seizure medication as a pain-reliever. On the other hand, the null hypothesis is that: for neuropathy, PEMF is not as effective as analgesics, tricyclics, and antidepressant and anti-seizure medication as a pain-reliever.
In this study, the frequency and gauss of the PEMF waveform will be varied depending on the extremity that shows the most symptoms. The times these therapies are conducted will vary following the intensity of the symptoms. Furthermore, the treatment plan will depend on the patients responses (Shealy, 2015). The pulsed electromagnetic field is applied to the patients feet, neck, and chest areas for 15 to 30 minutes. The varying pain intensity should be tabulated weekly after every treatment. The table of records should contain other information such as the age and the type of treatment the patient is currently undergoing. The data is analyzed after 8 weeks of treatment. It is expected that this treatment plan will lower the pain of at least twenty percent from the baseline (Shealy, 2015).
Theoretical Framework
Overview and Guiding Propositions
A researcher should consider three factors when choosing a theoretical framework for any research: validity, reliability, and comparability with data from other studies (Bastos, Duquia, González-Chica, Mesa, & Bonamigo, 2014). The validity of a theory is its ability to create results measuring what it is intended to measure. Internal validity means that the results of a study reflect the properties of the utilized theory. On the other hand, external validity means that these results can be correctly generalized to the population from which the sample is drawn (Bastos et al., 2014).
To locate an existing theoretical framework, a scholar should formulate a research question identifying the theories that are being investigated and applied at the same time (DePoy & Gitlin, 2013). Next, it is recommended to search scientific literature (e.g., journal articles, books) to find a proper and tested theory. The researcher should consider the reviews of the theory in the literature, its assessed validity, reliability, and comparability. If no appropriate theoretical framework can be located, the researcher can review the research question to develop his/her own (which is a tedious, difficult, and time-consuming process), or wait until a proper instrument is developed by others (Bastos et al., 2014).
Application of Theory to Study Focus
The research question is: In patients aged 30-60 with diabetic neuropathy, how effective is PEMF in reducing pain originating from this condition when compared to analgesics, tricyclic antidepressants, and anti-seizure medication? Consequently, the chosen theoretical framework should assess the levels of pain resulting from diabetic neuropathy in patients. Pain should be measured on an interval/ratio scale because its levels can be assessed.
The theory to be used for measurement in this study is the S-LANSS (Self-Completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale), which is a modification of LANSS scale that allows the questionnaire to be completed by the patient (Toth & Moulin, 2013, p. 14). S-LANSS is valid and reliable (Eckeli, Teixeira, & Gouvêa, 2016), and the validity and reliability of the original LANSS scale have been validated in several studies, including cross-cultural studies (Barbosa, Bennett, Verissimo, & Carvalho, 2014; Spanos, Lachanas, Chan, Bargiota, & Giannoukas, 2015). The scale is one of the most used instruments for assessing neuropathic pain nowadays (Toth & Moulin, 2013; Van Hecke, Austin, Khan, Smith, & Torrance, 2014), and is, therefore, comparable with other studies.
The theoretical framework for data collection procedures will include an initial assessment of pain using the S-LANSS instrument (questionnaires will be completed by patients; those with non-neuropathic pain will be excluded), and a post-treatment assessment ( The S-LANSS pain score , n.d.). The data will be collected and analyzed using statistical tools, possibly ANCOVA, to check whether this type of treatment can predict the post-treatment levels of pain using the pre-treatment levels of pain as the covariate (Field, 2013). More specifically, the level of pre-treatment neuropathic pain in each patient will be assessed using the S-LANSS scale and the results will be recorded, thereby creating a variable that will be used as the covariate in the subsequent ANCOVA ( ANCOVA , n.d.).
Methodology
Sample/Setting
The sample population belongs to a medical office complex that treats about 10,000 patients. Out of this total sample, 80% are of Hispanic background and residents of Passaic City in New Jersey (no samples from rural areas). About 400 have diabetic neuropathy with a different grade of pain at the feet. The study randomly samples 316 patients. Out of this sample, 158 patients will have medical treatment for pain with tricyclic antidepressants, anti-seizure medication, NSAIDs, Ibuprofen, 400 mg P0 oral route daily, Gabapentin 300 oral route daily, and Amitriptyline 25 mg oral route daily. All the sampled patients must have no contraindications with their dosage. Below is an outline of the experiments setting:
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Pulse-wave electromagnetic therapy with no contraindications 20 gauss strength and a 15 Hz frequency 25 min will be used
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Machines to be used: Brand Name- Oceanus, Model Number- OCE-ESWT-001&.Applications: physiotherapy / sports medicine / pain relief
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Type of machine: radial shock wave therapy device, pressure: 1.0-5.0 bar, and Frequency: 1-22 Hz, With an LCD touch screen display. Certified under ISO13485, used in hospital and beauty clinics, with the power supply: AC100-240V, 50/60Hz
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Schedule of experiments: From Monday to Friday for 12 weeks with an evaluation of questionnaires before, at the end of each week, and after treatments
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Personnel: Group of fifteen therapists including five nurses and two physicians will do the treatments and evaluations
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Expected interruptions: Inability of patients to follow treatment for medical reasons such as allergies gastritis, feet injuries, or patient-decisions
Sampling Strategy
The sampling will proceed with permission from and in collaboration with the hospitals management. Thus, the sampling strategy can be described as purposive sampling (Guyatt, 2014). This strategy employs a non-probability sampling technique and it does not allow the sample to represent the population as a whole accurately (DePoy & Gitlin, 2013). However, it is appropriate in this case because the research hypothesis restricts the scope of the study to individuals diagnosed with diabetic neuropathy. Any probability sampling strategy would require a significantly larger sample without necessarily improving the quality of results.
Research Design
The participants are expected to assess their levels of pain using the interval/ratio scale. Consequently, this allows the researcher to quantitatively analyze the results and answer the research question (Vogt, Gardner, & Haeffele, 2012). Therefore, the project has a quantitative research design. The design does not include a control group since this would significantly decrease an already-small sample size. The procedure is not blind since the pain treatment methods are noticeably different and do not allow for consistent blinding. Besides, it is expected that at least some participants will specify their inability to subject themselves to either EMF exposure or medication (Yadollahpour & Jalilifar, 2014). Therefore, the groups are to be formed at least partially based on the preferences of participants, which excludes randomization and suggests a quasi-experimental design (Vogt et al., 2012). This type of design is the most appropriate considering the size of the sample, the resources at the disposal of the research team, and the goal of the project.
Extraneous Variables
Extraneous variables are factors that can influence the outcome of a study by affecting the measurement of the studys inconsistencies and also the relationships between them (Grove, Gray, & Burns, 2015). In the current study, there might be several extraneous variables including the following:
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The severity of pain that a subject was experiencing before treatment: To account for it, it will be measured and used as a covariate in the ANCOVA
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The fact that severity of pain might be influenced by non-neuropathic pain: This variable will be controlled for by using an instrument, which differentiates between neuropathic and non-neuropathic pain
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The effectiveness of treatment might be influenced by environmental factors: For instance, if some patients do not stay in the hospital during treatment, this may have an impact on the quality of care and treatment effectiveness. This inconsistency will be addressed by the fact that the patients from both the experimental and the control groups will have different environments, so the error should be approximately the same on the average.
Instruments
The instrument that was selected for the current study is the S-LANSS (Self-Completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale). It is a modification of the LANSS scale, which is suitable for patients self-assessment. It was chosen over the LANSS scale because it permits for assessment of pain intensity (Toth & Moulin, 2013, p. 24). The tool includes several questions aimed at determining whether the pain is neuropathic or not. For instance, yielding an overall score from 0 to 24, where the values of e12 indicate neuropathic pain; this is, in fact, equal to a yes/no answer), as well as an 11-point scale for assessing the intensity of the pain (0=no pain, 10=the most severe pain) ( The S-LANSS pain score , n.d., p.1). It is important to measure the level of patients neuropathic pain before and after the treatment and compare the results across different treatment groups (Warner, 2013). S-LANSS should be adequate for this research because it measures the intensity of pain and identifies whether it is neuropathic.
Description of the Intervention
The first group of patients will be administered PEMF to address diabetic neuropathic pains. The patients will be exposed to a unidirectional semi-rectangular waveform with a frequency of 15 Hz and a strength of 20 gausses. The PEMF will be applied to the soles of the affected feet for 25 minutes for 9 sessions, which will take place from Monday to Friday. The second group of patients will be given analgesics, tricyclic antidepressants, and anti-seizure medication to address their diabetic neuropathic pains.
Data Collection Procedures
The data will be collected using the S-LANSS instrument. The S-LANSS questionnaires will be administered to patients in whom diabetic neuropathic pains will be suspected, before telling them their diagnosis based on medical tests. This activity will be done to assess the test-retest reliability of S-LANSS. After the treatment (of either PEMF or medication) is finished, the patients will be surveyed once again to assess the post-treatment levels of neuropathic pain. Eventually, all the data will be transferred into the electronic format and prepared for further statistical analysis.
Data Analysis Plans
Demographic variables for this research will include the patients age, gender, and ethnicity (Vogt et al., 2012). Other variables such as income level, educational level, family size, and other sociological data are not paramount to this research and can be disregarded. Descriptive statistics will allow describing and summarizing the information obtained in the research to find out if any valuable patterns emerge from it. For this research, there will be two methods of analyzing data:
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Measuring central tendency: This method will allow the researchers to find the mean of the patients age, to answer the questions on it.
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Measuring the spread: This method will allow the researchers to find the spread between the youngest and the oldest participants in the experiment (Hulley, Cummings, Browner, Grady, & Newman, 2011)
Ethical Issues
The use of PEMF has become a common application in the medical field especially in accelerating recovery after bone fractures and also in minimizing pain. In this study, PEMF will be used in connection with neuropathy among diabetes patients. Various ethical issues are connected with the use of PEMF. For instance, no objective criteria have been available to ensure appropriate magnetic field strength or type of electromagnetic field and few studies so far have investigated the physical principles responsible for the impact of electromagnetic fields on the human body (DePoy & Gitlin, 2013, p. 87). These barriers raise concern about the negative effects of using PEMF among less-informed patients. Nevertheless, there are several reliable studies when it comes to finding out how PEMF influences the nervous system, cell activities, and blood flow (Dutton, 2014). The previous works have indicated instances of ethical issues that manifest specifically in other PEMF related therapies.
Limitations of the Proposed Study
This study will be carried out under several assumptions including the belief that the reviewed literature was authoritative enough. Consequently, the basic analysis is undermined by the absence of a methodical literature review that includes mini studies. For instance, there is no meta-analysis of the reviewed literature including the levels of electrical stimulation that were used in each experiment (Weiss, Weiss, & Silver, 2016). Other limitations of the study include the fact that the sample size is not big enough, lack of scrutiny for the sampled patients, and the short duration of the research.
Implications for Practice
The results of this study are expected to indicate that PEMF is a viable alternative to pain medication. Increasing instances of Type 2 diabetes have made diabetic neuropathy a common condition. Consequently, efforts to come up with a therapy that can minimize pain among patients have increased, especially in the feet area. PEMF provides a safe and non-invasive way to reduce pain and inflammation that can be used to supplement and enhance currently existing healthcare modalities (Kalso et al., 2014, p. 34). Currently, the available PEMF machines consist of a wide range of choices for patients including pinpoints, body mats, and spot applicators among others.
References
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