Background and Significance of the Problem
Pulsed electromagnetic therapy 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). There is a reason to believe that the technique is useful when treating patients with diabetic neuropathy in pain reduction. The following research attempts to uncover if pulsed electromagnetic therapy can be employed to mitigate pain, especially in the refracted pain of diabetic neuropathic patients. Diabetic neuropathy is a disease that has raised concern; it is primarily a complication of uncontrolled diabetes mellitus.
Aslam, Singh, and Rajbhandari (2014) note that it involves damage to the blood vessels supplying the nerves resulting in loss of feeling and stimulation to the affected organ, the disease has raised concern over the years. Therefore, proper prevention and treatment techniques should be enacted to decrease neuropathy. Most of the patients have refractory leg pain, which is one of the major effects of the disease. Pulsed Electromagnetic Therapy was found to improve pain during treatment and recovery. The wavelengths and frequency that will be used in this study will not be causing a risk to the patients and the nurses doing the study.
Statement of the Problem and Purpose of the Study
One of the most complicated problems in diabetic neuropathy is the refractory pain of the lower extremities, particularly the feet. Sometimes nurses do not focus on treating this pain when managing diabetic patients. Observations, articles, and the testimonies of the recovering patients, or the patients undergoing treatment, this pain is immense and should not be ignored (Pawluk, 2011). A critical step in providing health care is availing the patient’s comfort. Administering painkillers are not advisable, as some of them (such as opioids) may cause drug addiction or other harmful side effects as nausea, abdominal pain, dizziness, and hepatic or renal impairment. This research paper aims to uncover ways in which the pain may be treated by first finding out its prognosis and looking at the possibility of Pulsed Electromagnetic Fields in treating the refraction pain on the lower extremities (Javed, Petropoulos, Alam & Malik, 2015).
Research Question
In patients between the age of 30 and 50 how effective, is PEMF in diabetic neuropathy when compared to other forms of treatment such as analgesics, tricyclics, antidepressants, and anti-seizure medication, on reducing symptoms and pain?
Hypothesis: Research and Null
The major hypothesis that can be formulated from this study should revolve around the possibility of PEMF as an effective form of treatment for diabetic neuropathy symptoms and healing when compared to others such as analgesics, tricyclics, antidepressant, and anti-seizure medication.
The Hypothesis
For neuropathy, PEMF is as effective as analgesics, tricyclics, antidepressants, and anti-seizure medication as a pain reliever.
The Null Hypothesis
For neuropathy, PEMF is not as effective as analgesics, tricyclics, and antidepressants, and anti-seizure medication as a pain reliever.
Identifying and Defining Study Variables
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 be varied per the intensity of the symptoms. The treatment plan will be varied according to the patient’s responses (Shealy, 2015).
Operationalize Variables
The pulsed electromagnetic field is applied to the patient’s feet, neck, and chest areas for 15 minutes. The varying pain intensity is tabulated after every treatment and every week. The table 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).
Literature Review
All sources 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, to experiments and randomized control trials using PEMF coils on various test subjects. These sources support the research directly and indirectly by providing data that proves the effectiveness of PEMF treatment in diabetic neuropathy and offer data that allows for a deeper understanding of the disease and treatments currently implemented, thus providing a base for comparison between current and experimental techniques.
Pathogenesis of Painful Diabetic Neuropathy
This review article was written by Aslam, Singh, and Rajbhandari (2014), and posted in Pain Research and Treatment journal. As the name of the article suggests, it provides insights into mechanisms of pathogenesis of painful diabetic neuropathy. 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. It 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 mechanisms of diagnosing the root of the problem are not very efficient (Aslam et al., 2014).
This review article is useful for research. It provides a deeper understanding of the mechanisms of painful diabetic neuropathy, which coincides with the purpose of this study. Also, the article indirectly supports the research by stating that current diagnosing mechanisms are inefficient, meaning that prescribing specific drugs to deal with diabetic pain is impossible (Aslam et al., 2014).
The material provided in this research is reliable and relatively recent. The authors are acknowledged as specialists in their respective fields, and their work is peer-reviewed and published in an esteemed medical journal.
Treatment of Painful Diabetic Neuropathy
This article reflects on the current methods of treatment for painful diabetic neuropathy. Saad Javed, Ioannis N. Petropoulos, Uazman Alam, and Rayaz A. Malik conducted the study in 2015. It was then published in Therapeutic Advancements in Chronic Disease journal. The study evaluates which drugs are considered the most potent in the treatment of PDN (Javed et al., 2015).
This research reaffirms that objectively assessing PDN is difficult, which is why drugs are required to cover a wide array of possible causes of pain, making precise interventions impossible. The article points out that the most popular medicines used to treat PND are antidepressants, aminobutyric acid analogs like pregabalin, gabapentin, and opioids. The research covers pathogenic treatment, symptomatic treatment, and nonpharmacological approaches including PEMF (Javed et al., 2015).
This article is important to the research. It provides insights into the modern pharmacological treatment of PND and reflects on its effectiveness. It also supports the use of PEMF, as it states that numerous studies found that electromagnetic pulses are very effective in diminishing pain.
The article was written and released in 2015, making it a recent and reliable source. It was published in an official medical journal and is a peer-reviewed source. The research is based on randomized control trials and peer-reviewed literature. The information presented in this article is deemed credible.
Drugs for Neuropathic Pain
This study provides an excellent overview of drugs currently in use for the treatment of neuropathic pain. It was published in the British Medical Journal in 2014, by Eija Kalso, D.J Aldington, and R.A Moore. Unlike the previous article, which provided an overview of all kinds of treatments, both pharmacological and nonpharmacological, this one is focused on reviewing the effectiveness, side effects, costs, safety, and mechanisms of drugs currently in use (Kalso et al, 2014).
The study mentions numerous drugs that could be used to address neuropathic pain. It coincides with the previous source and supports the choice of antidepressants and opioids as some of the most efficient ways of treating pain. The article mentions numerous adverse reactions to the most common types of PND treatment, such as somnolence, dizziness, and nausea use (Kalso et al., 2014).
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. This indirectly supports the purpose of the research. PEMF treatment does not have any major adverse reactions, making it a much safer option. Also, the study assesses the effectiveness of pain treatment, providing a point of comparison for non-invasive PEMF therapy procedures.
The article is deemed a credible source due to being a recent publication. It was 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 PLOS ONE electronic journal in 2013. This study assesses the effectiveness of pulsed electromagnetic field 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 justify its applicability to clinical practice (Lei et al., 2013).
The experiment concluded that PEMF therapy managed to reduce the sensitivity in the rat towards non-noxious physical and thermal stimuli, reverse abnormalities associated with diabetic neuropathy, and help reduce body weight associated with the disease. Also, PEMF was proven to have a corrective effect on damaged nerves (Lei et al., 2013).
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, the experiment provides an evidence base to support the hypothesis of this research. Also, the research provides plenty of data on how PEMF affects tissues on a cellular level, which helps in understanding the biological mechanisms of electromagnetic influence.
The article is peer-reviewed and relatively recent, thus making it a credible source of information. The only downside is that the experiment was conducted on lab rats, rather than humans.
Pulsed Electromagnetic Fields: How They Heal
This article was written by doctor William Pawluk. He is known for his studies of the PEMF, the creation of an authoritative informational source on PEMFs. Dr. Pawluk is the author of a book and several articles dedicated to PEMF therapy and provided consultations on the subject for numerous research projects. In his work, presented in 2011, he covers the basics behind the PEMF therapy and how it works, explaining the mechanisms of interaction with the body (Pawluk, 2011).
The article is used as a stepping stone for this research. It provides basic facts and information about what PEMF therapy is, its uses, side effects, and practices in healthcare. The information taken from this article can be used in the introduction part to acquaint the reader with the concept before moving on to more complicated subjects (Pawluk, 2011).
The author of this source is a certified medical specialist, which lends credibility to his statements. Also, the information he provided coincides with what is said in other reviewed sources. The article was published in 2011, making it a reasonably recent source.
Pulsed Electromagnetic Field Therapy with Mark II Coil for Diabetic Neuropathy
This study was published in 2015, as part of the Anti-aging Therapeutics journal. The experiment was conducted by C. Norman Shealy, the CEO of the National Institute of Holistic Medicine. The purpose of this research was to prove the efficacy of PEMF therapy in cases of diabetic neuropathy (Shealy, 2015).
In this experiment, Shealy 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 patient’s feet, chest, and neck. The results of the experiments were remarkable – after 8 weeks of therapy the patient’s conditions improved by over 50%. There was a significant decrease in pain. Pin, touch, and vibration sensation rates were also greatly improved (Shealy, 2015).
This research is crucial to our study as it provides great evidence to support the application of PEMF therapy in diabetic neuropathy treatment. The impressive results that are shown in this research warrant further study. This experiment correlates with the study performed on lab rats and is further supported by it.
The experiment is supported by numerous studies and publications as well as empirical data. It was conducted roughly a year ago, making it a very recent source. The results of the research were published in a peer-reviewed medical journal. It is a credible source of information.
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. This study deals with the effects of PEMF therapy in wound treatment (Yadollahpour & Jalilifar, 2014).
The research states that PEMF therapy has a promising effect in the treatment of many different wounds, such as ulcers, and in dealing with pain in post-operational treatments. This research covers strategies of wound healing, the interactions with the body on a cellular level, the biological effect of electric fields, and qualities and quantities measures for wound healing assessments (Yadollahpour & Jalilifar, 2014).
The study concluded that PEMF therapy has a positive effect on wound treatment. This is important for our research. Diabetes often causes ulcers, which serve as additional sources of pain. This research shows that PEMF therapy is useful not only for the treatment of diabetic neuropathy but also for dealing with various related side effects, which derive from it.
The research was conducted by two leading specialists of Ahvaz Jundishapur University of Medical Sciences and later published in a peer-reviewed medical journal. It is a credible, reliable, and recent source of information.
Research Sampling
Sampling is a very important process in any research. It introduces the collection of the units taken from the population to answer the proposed research question. In medical and clinical research, a sample includes people who meet the entry criteria and could be accessible to the researcher (Hulley, Cummings, Browner, Grady, & Newman, 2011). One of the first steps that have to be taken in research is the choice of a sample. The project aims to investigate the peculiarities of PEMF and its possible effects on diabetic neuropathy patients (Aslam, Singh, & Rajbhandari, 2014) and compare this treatment with other methods including analgesics, antidepressants, and anti-seizures. Therefore, it is important to choose a particular group of participants and make sure they can be helpful to the study. Selective methods should be identified (Dutton, 2014).
In this study, it is expected to use the convenience sampling technique. The respondents (diabetic neuropathy patients) will be recruited from local hospitals which will be willing to cooperate with the researcher. This technique is not a random sampling, but it is still appropriate because the medical effect of PEMF on patients should be similar irrespectively of the characteristics which could depend on the randomness of the sample (such as e.g. regional peculiarities of respondents, the difference in views, and so on); however, a researcher might wish to employ some elements of the purposive sampling technique–for instance, if the researcher judges that there are not enough representatives with certain characteristics, such as respondents from a certain age group; however, it is unlikely that this will be needed, because such characteristics should not be of major importance for the research question (Guyatt, 2014). Therefore, the described sample should reflect the population as identified by the problem of the research.
The effectiveness of PEMF will be compared to that of analgesics, antidepressants, and anti-seizures. This means that there will be at least 2 groups in the sample: patients who receive PEMF, and patients who receive analgesics, antidepressants, and anti-seizure (clearly, the combinations of these medications should be the same for all the patients). Consequently, the effects of the different types of therapy will be assessed across three variables: levels of pain, levels of depression, and severity of seizures.
It will be possible to carry out three analyses of covariance (ANCOVAs); each one will check whether the type of treatment can predict the post-treatment levels of a) pain, b) depression, and c) severity of seizures, using the pre-treatment levels of these as covariates (Field, 2013). It is stated that for detecting an effect of medium size (f =.25) with the power of.80 and the alpha level of.05, the required sample size is N = 158 participants (“Sample Size: ANCOVA,” n.d.). If it is desired to detect a smaller effect or to achieve greater power, a larger sample will be needed; for a different alpha level, the desired sample size will need to be re-calculated (Warner, 2013); otherwise, the sample of 158 respondents will be appropriate for the ANCOVAs as described.
It seems that it will be possible to generalize the findings of the study to the population of diabetic neuropathy patients who receive treatment from pain, depression, and seizures simultaneously (DePoy & Gitlin, 2013). Limitations may be related to the non-random sampling technique; for instance, certain confounders related to local specifics may exist (such as some characteristic of care in the local hospitals; this might be especially true concerning depression levels).
Research Design
In addition to an appropriate sampling technique, it is also crucial to develop an effective research design and explain its peculiar features. The design is the way of how research is structured and organized (Vogt, Gardner, & Haeffele, 2012). It introduces the directions to the researcher.
To answer the research question of the study, a quantitative research design will be used. It might be difficult to use a randomized controlled trial, for patients may have preferences regarding the type of treatment that they are desirous of receiving (medications or PEMF). Therefore, the researcher will have to accept that it is patients who decide which type of treatment to use. Consequently, the research design of the study will be quasi-experimental, because it will attempt to determine the impact of an intervention on the study participants without randomly assigning them to groups (Vogt et al., 2012).
The quantitative research will measure the levels of pain, depression, and the severity of seizures before and after the treatment. It will be required to use assessments that provide answers on an interval/ratio scale for carrying out the analyses of covariance when the data is gathered.
It should be stressed that the research design seems to flow from the proposed research problem, theoretical framework, and the study hypotheses, because it allows for comparing the effects of the different types of therapy (medication vs. PEMF), addressing the research problem and testing the hypothesis, within the given framework (Vogt et al., 2012). Besides, it is consistent with the literature review, which shows that PEMF may be effective in treating diabetic neuropathy patients (Aslam et al., 2014; Dutton, 2014; Yadollahpour & Jalilifar, 2014).
References
Aslam, A., Singh, J., & Rajbhandari, S. (2014). Pathogenesis of painful diabetic neuropathy. Pain Research and Treatment, 2014(1), 1-7. Web.
DePoy, E., & Gitlin, L.N. (2013). Introduction to research: Understanding and applying multiple strategies. St. Louis, MO: Elsevier Health Sciences.
Dutton, M. (2014). Dutton’s introduction to physical therapy and patient skills. New York, NY: McGraw-Hill Professional.
Field, A. (2013). Discovering statistics using IBM SPSS Statistics (4th ed.). Thousand Oaks, CA: SAGE Publications.
Guyatt, G. (2014). Users’ guides to the medical literature: A manual for evidence-based clinical practice. New York, NY: McGraw-Hill Professional.
Hulley, S.B., Cummings, S.R., Browner, W.S., Grady, D.G., & Newman, T.B. (2011). Designing clinical research. Philadelphia, PA: Lippincott Williams & Wilkins.
Javed, S., Petropoulos, I.N., Alam, U., & Malik, R.A. (2015). Treatment of painful diabetic neuropathy. Therapeutic Advancements in Chronic Disease, 6(1), 15-28. Web.
Kalso, E., Aldington, D.J., & Moore, R.A. (2014). Drugs for neuropathic pain. British Medical Journal, 348, 34-37. Web.
Lei, T., Jing, D., Xie, K., Jiang, M., Li, F., Cai, J., … Luo, E. (2013). Therapeutic effects of 15 Hz pulsed electromagnetic field on diabetic peripheral neuropathy in streptozotocin-treated rats. PLOS ONE, 8(4), 1-9. Web.
Pawluk, W. (2011). Pulsed electromagnetic fields: How they heal. Web.
Sample size: ANCOVA. (n.d.). Web.
Shealy, N.C. (2015). Pulsed electromagnetic field therapy with Mark II coil for diabetic neuropathy. Anti-aging Therapeutics, 17, chapter 18.
Vogt, W.P., Gardner, D.C., & Haeffele, L.M. (2012). When to use what research design. New York, NY: Guilford Press.
Warner, R. M. (2013). Applied statistics: From bivariate through multivariate techniques (2nd ed.). Thousand Oaks, CA: SAGE Publications.
Yadollahpour, A., & Jalilifar, M. (2014). Electromagnetic fields in the treatment of wound: a review of current techniques and future perspective. Journal of Pure and Applied Microbiology, 8(4), 2863-2877.