The Effects Of Pulsed Low Frequency Magnetic Field Therapy On Patients With Chronic Low Back Pain

Bio Electro Magnetic Energy Regulation (BEMER) Device- Therapeutic intervention

Discuss about the Effects of Pulsed Low Frequency Magnetic Field Therapy on Patients with Chronic Low Back Pain.

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 was procured in case of patients suffering from osteoarthritis of knee (2).

The primary outcome measures of pain intensity will be measured by means of 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 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 by 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 (3).

The outcome variables will be assessed based on various standardized pain assessment tools that will be adapted holistically to account for best possible treatment option and the relative efficacy of the pulsed low frequency magnetic field therapy in treating the patients with chronic low back pain. The following tools will be employed in this regard.

1. The Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ): It is considered as 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, sub-acute or chronic in nature. Internal responsiveness in conjunction with external responsiveness will also be considered as part of the measurement. The difference in time may be measured on the basis of this internal responsiveness of the test. Contrarily, the external responsiveness account for stating the association between the results measured by virtue of RMDQ with that of Global perceived Effect (GPE) Scale results (4).
2. Pittsburgh Sleep Quality Index (PSQI): PSQI accounts for a self-report questionnaire that assesses the quality of sleep over a time span of 1 month. It comprises of 19 individual items generating 7 components that culminates in the production of one global score. It takes little time for completion and is considered as a standardized sleep questionnaire for the researchers and clinicians alike to be utilized 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 whiling employing this test and finally interpreting the scores obtained. The validity and reliability of this tool has been tested to be implemented in actual research studies (5).
3. Brief pain inventory scoring (BPI): BPI is responsible for quickly estimating the severity of pain and its influence on functioning. It is primarily considered as a symptom assessment tool for harbouring clinically significant data that may be documented to support the medical product claims such as that occurring in case of a treatment intervention modality through patient reported outcome variable measures. It is extensively used in the clinical trials to support for the claims made by the 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 (6).
4. Global Perceived Effect of change (GPE): The GPE scale is widely used in 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 analyze the psychometric property of the questions asked. A combination of multiple important outcomes thereby allowing patients to integrate factors that render the patients to give an overall response concerning all these governing factors (7).
5. Owestry Disability Index: It is an index that in turn has been derived from Owestry low back pain questionnaire employed by clinicians and researchers to quantify the disability relevant to the low back pain. It consists of a self-completed questionnaire that has been validated early. It consists of ten topics that is 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. Each category of the relevant topic corroborates with 6 statements whereby each questions are measured on a scale of 0 to 5. The maximum disability score possible as per this tool is found to be 100 while the least is designated as 0 (8).
6. Disabilities of the Arm, Shoulder and Hand (DASH): It is a questionnaire that is considered as a self-administered region-specific outcome instrument developed as a measure relevant to self related upper extremity disability and symptoms. It comprises of a 30 item disability or symptom scale that is presented on a scale ranging from 0 to 100. The pre as well as post conditions following a medical intervention is generally applicable to such measurements where assessments are done based on the self reporting of treatment effectiveness after medical intervention. It is well capable of differentiating small and large changes of disability with the passage of time following therapeutic intervention for patients with upper extremity musculoskeletal disorder (9). The same will be applicable in case of LBP patients where efficacy of BEMER intervention will be measured.

Data Collection:

In the conduct of the study adequate emphasis will be laid on maintaining the confidentiality and authenticity of the procured data. All the data that will be collected in due course from the prospective candidates will be stored electronically in the personal computer of the chief researcher and secured by password. Care will be taken to ensure that the data will not be accessible to any unauthorised persons or disclosed to anyone without proper prior permission from the competent authority. Data that will be in printed forms will be documented and kept safely under the custody of the chief researcher in coded files so that no disclosure of the personal details of the participants are disclosed under any circumstances. The researcher will be responsible for safeguarding these protected data while themselves being aware of the codes. Other necessary hard copies pertaining to the detailed information of the subjects will be filed and kept with the chief researcher. Data will be made accessible only to the researcher and the corresponding supervisor. Finally on the completion of the study, data will be published in a collective manner without disclosing the identity of the patients and carefully archived in the files maintained by the researcher.

Data Analysis:

ersion 20 of the Statistical Package for Social Sciences (SPSS) software that has been installed in the personal computer of the chief researcher will be used for analyzing the data obtained from pertinent sources. Paired t-test will be employed to compare the differences for each of the groups separately before and after intervention. Additionally, the independent t-test will be adopted to calculate and compare the differences concerning both groups at the same duration of time in pre and post intervention conditions. The presence of significant differences in the respective groups will be scrutinized by means of utilizing these statistical tools. The level of significance for the statistical operations will be set at p<0.05 for the entire length of the study.

Sociodemographic Data

Data relevant to the participant’s age, body mass index (BMI), body surface area (BSA), educational level, and occupation besides disease histories will be obtained and presented as mean, median and standard deviation. All the data will be compared for the baseline data and homogeneity of both the control and experimental groups.

Self reported outcome measures

Paired t-test will be performed to carry out the compare and contrast the scores as reported by the subjects in both pre and post intervention condition with respect to the experimental group as well as the control group independently. Also, the independent t-test will be utilized for comparing the responses obtained from both the groups at the same time during initial as well as final assessments.

References:

1. Alayat MS, Atya AM, Ali MM, Shosha TM. Long-term effect of high-intensity laser therapy in the treatment of patients with chronic low back pain: a randomized blinded placebo-controlled trial. Lasers in medical science. 2014 May 1;29(3):1065-73.
2. Gyulai F, Rába K, Baranyai I, Berkes E, Bender T. BEMER therapy combined with physiotherapy in patients with musculoskeletal diseases: a randomised, controlled double blind follow-up pilot study. Evidence-Based Complementary and Alternative Medicine. 2015 May 20;2015.
3. Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005 Jun 1;30(11):1331-4.
4. Roland M, Fairbank J. The Roland–Morris disability questionnaire and the Oswestry disability questionnaire. Spine. 2000 Dec 15;25(24):3115-24.
5. Cole JC, Motivala SJ, Buysse DJ, Oxman MN, Levin MJ, Irwin MR. Validation of a 3-factor scoring model for the Pittsburgh sleep quality index in older adults. Sleep-New York Then Westchester-. 2006 Jan 1;29(1):112.
6. Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. The Clinical journal of pain. 2004 Sep 1;20(5):309-18.
7. Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. Journal of clinical epidemiology. 2010 Jul 31;63(7):760-6.
8. Fairbank JC, Pynsent PB. The Oswestry disability index. Spine. 2000 Nov 15;25(22):2940-53.
9. Gummesson C, Ward MM, Atroshi I. The shortened disabilities of the arm, shoulder and hand questionnaire (Quick DASH): validity and reliability based on responses within the full-length DASH. BMC musculoskeletal disorders. 2006 May 18;7(1):44.