1.1 Background and Aim of Study
Chronic lower back pain (LBP) is a frequently reported condition globally and especially in developing countries. The condition is associated with the inability of the patient to carry out normal daily activities. Various treatments options have been used in the management of chronic LBP. However, existing therapies such as exercise and other physical therapies have been indicated to have limited advantages.
The use of magnets and especially pulsed electromagnetic field therapy is indicated to have positive immediate and long-term effects on LBP patients. However, the efficacy of the pulsed electromagnetic field therapy depends on the device used in the delivery of the signal. There is a scarcity of studies on the effectiveness of pulsed low-frequency magnetic field therapy in the management of chronic LBP. Therefore, this study aims at determining whether the use of pulsed low-frequency magnetic field therapy results in the reduction of pain among patients with chronic LBP.
1.2 Methods and Measures
Fifty patients suffering from chronic LBP will be recruited and randomly allocated to experimental and control groups. The experimental group will receive BEMER therapy while the control group will receive placebo BEMER therapy. The study will take place for 3 months (12 weeks) with a total of 36 sessions (3 times per week) lasting 30 minutes/session. The pain intensity will be measured using a numerical rating scale at every session until the completion of treatment. But there are other questionnaires concerning sleep disturbance, depression, anxiety, stress and the functional level of disability will be measured at the first session and then re-evaluated every three weeks until the completion of treatment sessions (Roland-Morris Low Back Pain and Disability Questionnaire, Pittsburgh Sleep Quality Index – Item 6, Brief pain inventory scoring, Global Perceived Effect of Change, Oswestry Low Back Disability, and Depression Anxiety Stress Scales- 21).
1.3 Data Analysis
Version 20 of the SPSS program will be used for data analysis. Paired t-test will be used to compare the differences before and after intervention for each group individually. Also, independent t-test will be used to compare the differences in both groups at the same period of time: before and after intervention. The socio-demographic data will be analysed using means, and standard deviation.
1.4 Expected Results
It is expected that an immediate reduction in pain among the patients receiving BEMER administered pulsed electromagnetic field therapy will be recorded. It is also expected that, unlike the control group, long-term benefits and reduced readmission will be observed in the experimental group.
2 Literature Review
Lower back pain is a frequently reported condition with cases of first-time LBP patients being indicated at up to 15.4% annually while up to 90% of these cases seek remission annually (Hoy et al., 2010). Most of the LBP cases are chronic with prevalence being indicated as high among individuals who are aged above 30 years, as shown in Chart 1 (Meucci et al., 2015). Poor social support and educational background, stress, obesity, pregnancy, and anxiety are also indicated as increasing the risk of LBP (Hoy et al., 2010, Alleva et al., 2016).
Chart 1 Prevalence of chronic LBP with age (39)
LBP is associated with various impacts and outcomes. The impact of LBP is indicated to increase with age. (Dionne et al., 2006) The outcome of LBP is also high in low-income countries.(Hoy et al., 2010)Various factors have been indicated as mediating the impact of the disease, including socio-economic status, accessibility of health services and the distribution of occupations. Studies have shown that LBP affects various individuals by causing functional impairment. The factors that have been suggested to increase the occurrence of functional impairment in LBP include physiological, socioeconomic and psychological status.(McGorry et al., 2011)LBP, especially nonspecific LBP (NSLBP) cases, has been suggested to be caused by multiple factors. No certain single cause has been identified in about 85% cases of LBP.(Deyo and Weinstein, 2001, Ehrlich, 2003) It is based on this understanding that a number of methods have been developed to manage various cases of chronic LBP. Various researchers have suggested the need for treatment of LBP to focus on improving the patient’s ability to function physically and socially rather than focusing on simply relieving pain, but most studies looking into unfitness for work and the loss of income have concentrated on younger people, leaving out elderly individuals.(Heymans et al., 2007)
2.1 Treatment of LBP
Some of the options being used to treat LBP include acupuncture, exercise, massage, yoga, cognitive-behavioural therapy, progressive relaxation, manipulation of the spine and interdisciplinary rehabilitation on an intensive scale. (Chou et al., 2007) However, studies have shown that the efficacy of the therapies varies, with some studies indicating the presence of similarity between the effectiveness of some treatment such as transcutaneous electrical nerve stimulation (TENS) and placebos .(Khadilkar et al., 2008) The use of exercise has also been shown to have limited advantages, with patients being observed to encounter recurrent pain. (Airaksinen et al., 2006) An alternative to existing therapies is the use of electromagnetic field therapy. As earlier indicated by Finegold and Flamm, magnetic apparatus such as mattresses, pillows, neck and back braces, knee and wristbands, insoles, and braces, which have magnetic properties, has therapeutic potential for LBP patients.(Finegold and Flamm, 2006) Various studies have shown that magnets have long been used in the treatment of LBP; however, their efficacy is suggested to be low. (Shen et al., 2006), (Finegold and Flamm, 2006) Some studies, however, argue that the use of magnets in the treatment of LBP results in a significantly positive outcome. The use of magnets in a case involving a male aged 15 with chronic pain in the lower abdominal quadrant, groin and thoraco-lumbar area was observed to result in pain relief 600 seconds after the therapy session. (Loo, 2009) One form of magnet-based therapy used in the treatment of LBP is the pulsed electromagnetic treatment that is discussed in the subsequent section.
2.2 Application of Pulsed Electromagnetic Field Therapy in the treatment of chronic LBP
The use of pulsed electromagnetic field therapy was approved in 1979 by the Food and Drug Administration (FDA).(Lee et al., 2006) One study that used a numerical rating scale to assess pain reduction showed that pulsed electromagnetic treatment can decrease disability and pain among individuals with chronic LBP.(Lee et al., 2006)The researchers noted that the pain decreases to a percentage range of between 38 and 31% twenty-eight days and immediately after therapy, respectively.(Lee et al., 2006) However, the same study observed that the outcome in the placebo group was up to 22%, raising questions about the efficiency of magnetic therapy as a form of treatment.(Lee et al., 2006) Another study that used a medical device resonator to convey the electromagnetic field treatment to the participants who underwent five sessions of medication procedure over a 14-day period noted that in the last two days of treatment, the study participants with chronic low back pain indicated that the intensity of pain had reduced .(Arneja et al., 2016) The study also demonstrated that at such minimal levels, it is possible to efficiently reduce the intensity of pain in chronic LBP patients. (Arneja et al., 2016) However, a study that showed that pulsed electromagnetic field therapy is key in pain relief among LBP patients indicated that the huge array of the procedures utilised while applying the pulsed electromagnetic treatment and the different parameters and devices that are employed by the investigators, as well as the dissimilar frequencies and time of utilisation, results in difficulty in comparing the obtained outcome. (Andrade et al., 2016)It is suggested that the use of a magnetic field produced by pulses with a flux density of 15 mT over a 14-day period might be efficient in the management of chronic LBP. However, the researchers indicate that further research is needed to confirm their findings and to provide more clarification on the efficacy of the therapy.(Harden et al., 2007)The use of pulsed electromagnetic field therapy has been indicated to yield positive outcomes compared to microcurrent treatment. This is evident in a study that involved post-menopausal females who underwent a month of treatment involving three therapy sessions every seven days at an intensity of 20 Gauss and a frequency of 10 Hz.(Abdel-Raoof N, 2011) Some of the reasons given for pain reduction included the lowering of the cell membrane to hyperpolarisation phase, which hinders the transmission of pain impulses and presynaptic inhibition, among others. (Abdel-Raoof N, 2011) A clinically significant outcome on the use of pulsed electromagnetic therapy was also observed in a study examining the treatment of chronic pelvic pain using sono-electro-magnetic therapy.(Kessler et al., 2014) The study used the pain index provided by the National Institutes of Health in determining its efficiency. The efficient treatment of discogenic lumbar radiculopathy by the use of pulsed electromagnetic field therapy was observed in a study that used the Oswestry Low Back Pain Disability Questionnaire (OSW) and the Visual Analogue Scale (VAS) to examine pain intensity.(Omar et al., 2012) Despite the observed efficacy of pulsed magnetic field therapy, the dissimilarity in the signal setups in the devices that deliver the pulsed electromagnetic field is suggested to cause variations in the efficacy levels. (Gyulai et al., 2015) One of the devices, the Bio-Electro-Magnetic-Energy-Regulation (BEMER) device, is stated to function using a weak magnetic field and unique factors. (Gyulai et al., 2015) Various researchers have indicated that the use of a weak magnetic field has immediate and long-term benefits .(Gyulai et al., 2015) However, more research needs to be done to verify these assertions. This is particularly important given the variations in the time taken for pain relief to be achieved while using this form of therapy.(Gyulai et al., 2015),(Kubat et al., 2014)
3 Aim and Significance of the Study
3.1 Aim of the Study
The aim of this study is to investigate the efficacy (PEMF) Therapy on the reduction of pain intensity among patients with chronic LBP.
3.2 Significance of the Study:
LBP has various impacts on the lives of the patients. The disease is indicated to negatively affect the functional ability of the patients. Various treatment options have been used in the management of chronic LBP. However, existing therapies such as exercise and other physical therapies have been indicated to have limited advantages.
The use of magnets and especially pulsed electromagnetic field therapy is indicated to have positive immediate and long-term effects on LBP patients. However, the efficacy of the pulsed electromagnetic field therapy depends on the device used in the delivery of the signal. Devices such as the BEMER, which is capable of delivering PEMF, are suggested to be efficient for chronic LBP management; however, limited research has been done to ascertain the effectiveness of such PEMF therapy for chronic LBP.
Therefore, this study is expected:
- To assess the effectiveness of this form of therapy while providing key insights into the effect of the therapy on specific cases of chronic LBP.
- To give recommendations on the use of pulsed low-frequency magnetic field therapy in pain relief among patients with chronic LBP.
- To introduce cost-effective treatment options for chronic LBP.
4 Methods and Procedures
4.1 Design of Study:
A Randomised Double Blind Placebo Controlled Trial
5 Overview of Approach
5.1 Population and sample
The subjects will include both female and male patients recruited from King Fahad specialist hospital, Dammam, Saudi Arabia, diagnosed with various degrees of chronic lower back pain. The hospital has a patient population reporting with chronic lower back pain referred from family physicians, physical medicine and rehabilitation, orthopaedics and rheumatology departments. In order to minimise confounds and to allow for a stringent study design, several inclusion and exclusion criteria will be applied; these will be discussed in the subsequent sections of this write-up. Only those subjects who are able to meet the selection criteria will be selected. Not all of the people within the population will be included in the study. Rather, a sample of 50 patients will be selected randomly for the study.(Gyulai et al., 2015) 50 patients will be selected because this number is considered neither too large nor too small for an action research of this nature. For example, with 50 people, it will be possible to divide them into a Group A as the experimental group and Group B as the control group each group 25 patient. Dividing the sample will be done through simple random sampling, whereby a balloting system will be used. Randomisation will be carried out by the subject drawing an envelope containing a preassigned number. The envelope will be handed unopened to the Technicon, who will open the envelope in the control room where no other persons involved in the study are present. Inserts of envelopes containing even numbers will be assigned to the experimental group, whereas inserts of envelopes containing odd numbers will be assigned to the control group.(Arneja et al., 2016) Prior to being enrolled in the study, the potential participants meeting the selection criteria will be issued with informed consent documentation. The researcher will explain to the potential participants about the proposed research methodology, the research goals and the role that the recruited participants will play in the study. Upon understanding the facts concerning the study, the patients will be asked to sign the informed consent form. The researcher will ensure that the participants sign the informed consent form through their own free will. The patients who meet the selection criteria will be randomly assigned to one of two groups. The first group of 25 patients will be the experimental group that will receive the BEMER therapy and the second group, which will also be made up of 25 patients, will be the control group that will receive placebo BEMER therapy. The participants will be blinded to the identity of the treatment group until after the data has been analysed.(Krammer A, 2015)
5.2 Sample Size Calculation
Sample size is calculated using the study of (Omar et al. 2012) as a reference, in which pain intensity on a visual analogue scale (VAS) was the primary outcome of interest. The mean number of the study group who received PEMF therapy was (3.6) with a standard deviation of (1.5), while the mean number of the control group who received placebo treatment was (5.8), with a standard deviation of (2.7). Mean and standard deviation scores were all calculated at a significance level (alpha) of 5% and power (1-beta) of 90%. In other words, the total sample size required is 40 to have a 90% chance of detecting as significant at the 5% level, while the sample size required per group is 20 patients. But to decrease the chance of drop-out from study I will increment the sample size to 25% in each group, therefore the total sample size will be 50 patients while Sample size required per group is 25 patients.
5.3 Inclusion Criteria for Patients with Chronic LBP include:
- Male or female aged 18 to 60.
- Primary complaint of pain in the area between the 12th rib and buttock crease, with or without leg pain; at KFSH-D.
- Ability to read, understand, and follow study instructions.
- Pain intensity of at least 5, on 0-10 NRS pain scale.
- Experiencing low back pain for more than 12 weeks.
5.4 Exclusion Criteria for Patients with Chronic LBP include:
- Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome, spinal fracture).
- Currently taking recommended regular doses of analgesics.
- Has had spinal surgery within the preceding 6 months.
- Existing or planned pregnancy.
- History of epilepsy
6 Tools and Instrumentations
6.1 Bio-Electro-Magnetic-Energy-Regulation (BEMER) Device
It is a revolutionary and novel technology that is currently applied as a therapeutic modality to achieve the desired outcomes of enhanced circulation, nutrient supply and waste disposal, along with enhanced cardiac functions, endurance, strength, physical fitness and energy levels coupled with the advantages of having increased concentration, mental acuity, relaxation as well as stress reduction, thereby improving the quality of life. BEMER has been used an adjuvant therapy in patients suffering from knee osteoarthritis and chronic low back pain, thereby acting as an effective physical vascular therapy causing reduction in pain and fatigue for the short term in patients with chronic low back pain, while beneficial outcomes in the long term have been procured in the case of patients suffering from osteoarthritis of the knee.(Gyulai et al., 2015) The BEMER therapy device is non-invasive and allows for gentle and holistic intervention strategies. The BEMER therapy, made possible by the BEMER therapy device, is based on the principle that charged molecules in the cell are capable of reacting with magnetic fields, resulting in enhanced biochemical reactions that eventually result in positive physiological effects such as body healing.(Gyulai et al., 2015) The positive physiological effects associated with BEMER therapy include improved oxygen supply, enhanced circulation, activation of cellular metabolism, enhanced healing process and cellular regeneration, increased removal of toxins and improved general well-being and fitness level. The BEMER therapy device is indicated to be efficient in the treatment of conditions such as persistent pain and ailments of the joints and spine. The results obtained from BEMER therapy are indicated to be consistent. A success rate of between 70-90% has been reported among chronically ill patients on BEMER therapy for a treatment period of four to 52 weeks.(Gyulai et al., 2015)The use of the BEMER therapy is not associated with any known side effects to the patients and poses no harm to the person operating it. The therapy is also indicated to be easy to operate and safely applied. The BEMER device kit consists of three main items that include the control unit, intensive applicator, and a mat. The mat contains copper coils that extend through its length. The copper coils in the mat are arranged to fit the target area where the device is to be used; for example, the copper coils meant for use in the legs are wound in ovals. The coils are usually positioned between the shoulders and pelvis when a patient lies on the mat. The mat is plugged into a control unit that is connected to an AC source. The control unit provides an interface through which the commands are made on the level of voltage required. The control unit allows for time to be adjusted within a range of eight to 10 minutes. An applicator is an alternative to the mat and can be strapped in a specified region of the body. Unlike the mat, the applicator allows for high intensity and deeper effects on a certain region of the body.(Gyulai et al., 2015)The image (Figure 1) below shows the BEMER device.
Figure 1 BEMER Therapy Device
Adapted from: http://www.bemer3000review.com
6.2 Primary outcome measures
Numeric Pain-Intensity Scale (NRS) The primary outcome measures of pain intensity will be measured by means of the Numerical Pain Rating Scale. The tool is based on the rating of pain intensity by the patient. The scores adopted by the numeric pain-intensity scale range from zero to 10, with the lowest score indicating no pain and the highest score indicating the presence of the worst pain .(Jensen MP, 2001)The numeric pain-intensity scale is regarded as a pain assessment tool that is easy to administer. The tool has also been validated for use in the measurement of pain intensity among patients with known pain.(Jensen MP, 2001) The numeric pain-intensity scale is also indicated to have modest accuracy in identifying patients with clinically significant pain.(Krebs et al., 2007)
6.3 Secondary outcome measures
The Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ): This is considered a valid and reliable technique to evaluate self-rated physical disability caused due to low back pain. It is found to be most sensitive and suitable for patients suffering from mild to moderate disability because of low back pain ranging from acute, to sub-acute or chronic in nature.(Roland and Fairbank, 2000) The Roland-Morris Low Back Pain and Disability Questionnaire is made up of twenty-four questions that are obtained from the sickness impact profile questionnaires, which contain a total of 136 items.(Muller et al., 2004) The questionnaire assesses the disability associated with the natural history of LBP. The questionnaire evaluates patients’ daily living aspects such as sleeping, walking, lifting, resting and housework. The questionnaire also assesses the effect of LBP on the patient’s appetite, dressing, and self-care. The scoring of the statements included in the questionnaire is based on the fact that a higher score reflects a higher case of disability.
Pittsburgh Sleep Quality Index (PSQI): PSQI accounts for a self-report questionnaire that assesses the quality of sleep over a time span of one month. It comprises of 19 individual items generating seven components that culminate in the production of one global score. It takes little time for completion and is considered a standardised sleep questionnaire for researchers and clinicians alike to utilise in various settings relevant to diverse populations for diagnosing sleep disorders. Sleep efficiency, perceived sleep quality and daily disturbances are the three confounding factors that are taken into consideration while employing this test and finally interpreting the scores obtained.
The validity and reliability of this tool have been tested for implementation in actual research studies. (Cole et al., 2006) The score for each combination is totalled to obtain a global score of between zero and 21 for questionnaires with seven combinations. The
Pittsburgh Sleep Quality Index is indicated to have an acceptable sensitivity (89.6%) and specificity (86.5%) For the proposed study, the sixth item of the Pittsburgh Sleep Quality Index will be considered. The item specifically assesses the overall quality of the patients’ sleep within a predefined period of one month. The table below gives a
|Item||Very Good (0)||Fairly Good (1)||Fairly Bad (2)||Very Bad (3)|
|During the past month, how often have you taken medicine (prescribed or “over the counter”) to help you sleep?
description of the sixth item of the Pittsburgh Sleep Quality Index.
Table 1 The description of Pittsburgh Sleep Quality Index – Item 6 (Buysse et al., 1989)
Brief pain inventory scoring (BPI): BPI is responsible for quickly estimating the severity of pain and its influence on functioning. It is primarily considered to be a symptom assessment tool for harbouring clinically significant data that may be documented to support medical product claims, such as that occurring in the case of a treatment intervention modality through patient reported outcome variable measures. It is extensively used in clinical trials to support the claims made by pharmaceutical or other medical agencies. In this case, the fruitfulness of the BEMER application for persons suffering from chronic LBP will be assessed through this guiding tool.(Keller et al., 2004)
The use of the brief pain inventory scoring in the determination of pain intensity among patients with LBP has been shown to have acceptable validity. The tool is made up of nine statements, with some of the statements consisting of further questions. All of the statements are scored from zero to 10 or 0% to 100% for some statements. The lowest score indicates the presence of the least negative effect of the back pain, while a high score indicates an increased negative effect of the LBP.(Song et al., 2016)
Global Perceived Effect of change (GPE): The GPE scale is widely used in the case of patients afflicted by musculoskeletal disorders. It takes into consideration the vital factors related to bodily pain, mental health, physical role, social and physical functioning, health transition, emotional role and general health, while calculating the quality of life through this tool, and follows a question-and-answer format of assessment to analyse the psychometric property of the questions asked. A combination of multiple important outcomes allows the patients to integrate factors to give an overall response concerning all of the governing factors .(Kamper et al., 2010)
This is a form of clinical measurement of the recovery based on the patients’ rating. The approach is based on questions such as ‘To what degree have you improved or otherwise deteriorated since yesterday (or the last time of measurement)?’ The global perceived effect of change scale is a transitional scale in which the patient rates his/her recovery within a predefined period based on a numerical scale. The approach is easy and quick to administer and the outcome is simple to interpret. The global perceived effect of change scale is indicated to enhance the application of information from clinical trials to practice. The use of the scale also enables the patients to rate the aspects that are important to them. (Kamper et al., 2010) The global aspects of change targeted by the global perceived effect of change scale are multidimensional and include various aspects of patients’ health status, such as quality of life and pain.(Kamper et al., 2009)
Oswestry Disability Index (ODI): This is an index that was in turn derived from the Oswestry low back pain questionnaire employed by clinicians and researchers to quantify the disability relevant to low back pain. It consists of a self-completed questionnaire that has been validated early. It consists of ten topics that are related to the intensity of pain, ability to care for oneself, ability to sit, lifting capability, ability to walk, sexual functioning, social life, ability to stand, sleep quality supported by ability to travel. (Fairbank and Pynsent, 2000)The ODI is considered to be an important tool in the measurement of the low back functional outcome. The questionnaire is made up of 10 sections; each section has a maximum possible score of 5 with the first statement having a score of zero and the last statement having a score of 5.(Davidson and Keating, 2002) The score obtained from the Oswestry low back disability index is interpreted based on the directions provided in Table 2 below:
|0% to 20%: Minimal disability||Patient has the ability to carry out daily activities. Treatment is not mandatory but the patient can be guided on exercise to engage in.|
|21% to 40%: Moderate disability||Patient expresses pain while sitting and standing. Social life and work may be affected. Conservative care required.|
|41% to 60%: Severe disability||Patient’s ability to carry out daily activities is affected. Detailed investigation required.|
|61% to 80%: Crippled||Back pain hinders all daily activities. There is need for positive intervention.|
|81% to 100%:||Patient is bed-bound.|
Table 2 The Interpretation of Oswestry Low Back Disability questionnaire scores (Fairbank and Pynsent, 2000)
Depression Anxiety Stress Scales (DASS-21) self-administered questionnaire designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. The DASS Depression focuses on reports of low mood, motivation, and self-esteem, DASS-anxiety on physiological arousal, perceived panic, and fear, and DASS-stress on tension and irritability.(Parkitny and McAuley) Subjects were asked to use a 4-point severity/frequency scale (0=Did not apply to me at all, 1=Applied to me to some degree, or some of the time, 2=Applied to me a considerable degree, or a good part of the time, and 3=Applied to me very much, or most of the time) to rate the extent to which they have experienced each state over the past week. Scores.(Edimansyah et al., 2008) for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms. Maximum score: 63 for the DASS 21-item.The DASS-21 has been shown to possess adequate construct validity and reliability.(Henry and Crawford, 2005)
7 Treatment of Chronic LBP
7.1 Treatment Protocol
The primary outcome measures of pain intensity will be measured by means of the Numerical Pain Rating Scale, whereby the patients will be asked to make three pain ratings corresponding to the current, best and worst pain experienced over the span of the past 24 hours. The average of the three ratings will be used to measure the patient’s level of pain over the previous 24 hours. The treatment intervention following the BEMER application will be evaluated using this pain assessment tool in both the experimental as well as the control group in pre- and post-intervention conditions on a 10-point scale, having segmentations that denote mild, moderate and severe pain progressively. (Childs et al., 2005)
BEMER therapy will also be administered to the participants based on their individual treatment groups. The experimental group will receive the BEMER therapy, while the control group will receive placebo BEMER therapy. The BEMER therapy will be carried out for a period of 3 months (12 weeks) with a total of 36 sessions (3 times per week) for 30 minutes/session. The therapy will be administered to the patients with chronic LBP using 7–35 microTesla, intensive applicator. The pain intensity will be measured using the NRS pre- and post-intervention every session until the completion of treatment sessions; the pain intensity will then be evaluated using the NRS. Other questionnaires concerning sleep disturbance and the level of functional disability of activities of daily living will be measured at the first session and then re-evaluated every three weeks until the completion of the treatment sessions. Those are (RMDQ), (PSQI) Item 6, (BPI), (GPE), (ODI) and (DASS-21). The procedure that will be adopted is discussed below.
7.2 Study Procedure and Protocol
- Patients will be recruited based on the outlined selection criteria, after which they will be booked in the physical therapy clinic. The study’s population will comprise of patients in King Fahad specialist hospital at Dammam province, diagnosed with various degrees of chronic lower back pain, who have medical file records. As a very large health facility, the hospital has a patient population reporting with chronic lower back pain referred from family physicians, physical medicine and rehabilitation, orthopaedics and rheumatology departments.
- Each patient will also be allowed to ask any questions before signing the informed consent form. This will take one hour per patient. During this first visit, the patient will undergo a physical examination prior to the therapy sessions, using the initial evaluation form. The basic socio-demographic data of the patients will be taken using the data collection sheet The patients will also be trained how to record their pain intensity on the numerical pain rating scale in their initial assessment and issued with progress forms for subsequent visits On the designation, the NRS will be used to record the amount of pain that the patient is undergoing and the progress of the pain, since the patients will take this test regularly.
- Then other tests will be carried out:
- (RMDQ), which will be used to analyse the physical disability of the patients. This technique enables the researcher to keep a clear track of what the patient is going through during this period.
- (PSQI) Item 6 to determine the sleeping habits of the patients. Most sleep disorders are caused by pain, which makes it hard for the patient to have a good quality sleep.
- (BPI) to assess the pain the patients have in their lower backs.
- (GPE) to assess the effect of change that will be used to analyse the muscle skeleton disorder.
- (ODI) will be used to quantify the ability that comes with lower back pain.
- (DASS-21) will be used to assess the fundamental symptoms of depression, anxiety and tension/stress.
- That will be carried out every three weeks
- The patient’s current condition will be recorded, considering all of the factors that have been tested before they start the electromagnetic field therapy. The patients will be put in one of two different groups; the first group will receive BEMER therapy, and the other group will receive placebo BEMER.
- After each BEMER therapy session, the patient will be re-evaluated for pain intensity using the NRS
- A follow-up period of 3 months (12 weeks) with a total of 36 sessions (3 times per week) will then be conducted.
- The final evaluation will be at the last visit (i.e. the 36th session); then the patient will be discharged.
8 Data Management and Analysis
8.1 Data Collection
Ethics in the handling and storage of the collected data will be adhered to. The data collected will be coded in order to conceal the identity of the participants. The data will be stored in a password-protected laptop while the printed data will be kept in locked cabinets. No other person will be allowed access to the data apart from the lead researcher and his supervisors. The data will only be used for the intended purpose. The data will also be kept in a safe place after the completion of the project. The data will not contain the patients’ details; it will be in a language that only the researcher and the supervisor understand. Data will be published after completion without the identities of the patients.
8.2 Data Analysis
The data will be analysed using the Statistical Package for Social Sciences (SPSS) Ver. 20 installed in the lead researcher’s computer. Paired t-test will be used to compare the differences before and after the intervention for each group individually. Also, independent t-test will be used to compare the differences in both groups at the same period of time: before and after intervention. The socio-demographic data will be analysed using mean and standard deviation.
8.3 Expected Results
Taking into consideration the outcomes from previously conducted studies, it is expected that an immediate reduction in pain among patients who receive BEMER-administered pulsed low frequency electromagnetic field therapy will be recorded. It is also expected that, unlike the control group, long-term benefits and reduced readmission will be observed in the experimental group