The application of devices Magofon-01 and Almag-02 In the treatment of dorsopathy (Spinal Osteochondrosis, herniated disks)

Park Hospital

Gurgaon, Haryana, India, 2018

Dr Ajay Abrol MD Orthopedic surgeon Chairman, Abrol Medical Center

Dr. Rajani Bala Head of Physiotherapy Department Abrol Medical Center

Dorsopathies are among the world’s top degenerative diseases of the musculoskeletal system. They are a common and essential cause of spinal pain and of physical activity reduction among the elderly. Population aging is significantly changing the demographic situation, which is why the issue of dorsopathy becomes especially important [1,2,3]. What makes it difficult to apply physiotherapy is the fact that aging is inevitably accompanied by polymorbidity, which is often a significant constraint for prescription of a standard therapy. [4,5]. Especially urgent is the problem of a wide occurrence of cardiovascular pathology among the patients. One of the methods of physiotherapeutic treatment, which is generally recommended even in the presence of comorbidities, is the exposure of the body to a travelling pulsed magnetic field (TPMF). However, to date there has been no convincing evidence of the clinical and economic effectiveness of TPMF in osteoarthrosis patients. It is also of interest to study the effect of magnetic therapy with TPMF on the quality of life of patients with knee osteoarthrosis. [6,7].

Purpose of study: conducting a clinical and economic analysis of applying complex exposure to magneto-therapy in patients with dorsopathies.

Study objectives:

• conducting a clinical study of the efficacy and safety of applying magneto-therapy devices on patients receiving medical care for dorsopathies of the lumbar spine, at a medical facility that functions as the clinical base for this study;
• conducting a clinical and economic analysis of using magneto-therapy devices for dorsopathy.;

Study design: prospective, randomized, placebo-controlled, blind (for patients).

The study involved 20 patients: 10 patients in the index group and 10 patients in the placebo group, diagnosed with deforming dorsopathies. The index group consisted of 7 men, whose average age was 43.29 years, and 3 women, whose average age was 56.33 years. In the placebo group, the study involved 7 men, whose average age was 58.57 years, and 3 women, whose average age was 56 years.

All the study participants (in the index and control groups) were prescribed with standard medication therapy (non-steroid anti-inflammatory drugs, muscle relaxants); for the control group patients, physiotherapy was replaced with a simulated exposure to placebo devices that looked and weighed the same as the standard devices, while the index group patients were receiving combined physiotherapeutic exposure. In the first 4 days, along with standard drug therapy, physiotherapy was prescribed as follows: the affected spinal region was first exposed to an alternating magnetic field of 50 Hz frequency and 30 mT density, which was combined with 6-minute-long vibro-therapy of acoustic pressure frequency range from 20 to 20,000 Hz (with «Magofon-01» device). After that, without interruption, exposure to a traveling pulsed magnetic field (by «Almag-02» device) of the following parameters was administered: exposure density on the affected spinal region was 10 mT, on the projection of the affected nerve was 20 mT, with the exposure frequency of 100 Hz and duration of 10 minutes. From the fifth day onwards, physiotherapy was applied only with travelling pulsed magnetic field, with the density of 10 mT on the affected region and of 25 mT on the affected nerve area, with a frequency of 12 Hz and exposure time of 10 minutes.

To assess the treatment efficacy, the following were used: visual analogue scale (VAS) of pain, pain questionnaire, the SF-36 survey to assess a patient's quality of life, and the neuropathy total symptom scale (NTSS-9).

The obtained data were processed by means of primary mathematical statistical analysis using the statistical software package STATISTICA`6, SPSS for Windows, version 12. After verifying the intra-group data in terms of the distribution pattern, a Fisher (F) criterion one-way ANOVA test of the effect of the organized factor was conducted. For each intra-group indicator, the standard deviations, the mean values and errors of means, as well as the significance of differences in mean based on Student’s t-test, were determined.

Results and their interpretation

While assessing changes in pain syndromes of patients with dorsopathies over the treatment course, positive changes were observed both in the index group of patients and in the placebo group.

In the index group, the indicator of maximum pain intensity had significantly reduced over 4 weeks (from 7.18±0.44 to 3.7±0.58; p<0.01), with the influence of the «therapeutic effect» factor being significant (F=21.9, p<0.001). The current intensity of pain was very significantly affected by the treatment course: (F=26.2, p<0.001), with the nature of changes being positive (reduction of pain from 8.8±0.24 to 6.2±0.44; p<0.01). The character of perceived pains changed in a particularly noticeable manner (from pronounced to milder ones: F=57.8, p<0.0001, the initial character of pain 8.5±0.25 decreased to 5.2±0.41; p<0.001. Much less change was observed as pertaining to certain types of pain. Thus, it was not possible to confirm a significant change in burning pains during treatment (t=1.4, p>0.05, F=0.86, p>0.05), as well as in pains resembling an electric shock (t=0.48, p>0.05, F=0.21 p>0.05). Meanwhile, pains of another character showed a pronounced change: a significant decrease in stabbing pains was noted (F=11.7, p<0.01, t=4.65, p<0.01), in paraesthesia-type pains (at light contact) - F=9.8, p<0.01, t=3.63, p<0.05; in pains accompanied by numbness (F=9.6, p<0.01, t=5.3, p<0.01); as well as in pains when exposed to hot or cold objects (F=5.1, p<0.05, t=2.68, p<0.05).

The placebo group was also experiencing positive effect of the course exposure in terms of the pain reduction criterion; however, the level of pain reduction was lower than that in the index group. Thus, the indicator of the maximum pain intensity had significantly reduced over 4 weeks (from 7.5±0.6 to 5.7±0.75; p<0.05), with the degree of influence of the «therapeutic effect» factor being statistically significant (F=3.08, p<0.05). The current intensity of pain tended to decrease, but did not reach a statistically significant level: (F=2.2, p>0.05), with the nature of the changes being positive (reduction of pain from 9.0±0.52 to 8.0±0.47; p>0.05). It was noted that a number of pain types in the placebo group demonstrated positive changes: there was a significant decrease in stabbing pains (F=4.2, p <0.05, t=3.8, p<0.01), in pains when pressing a finger against spots in the back: - F=7.62, p<0.01, t=3.8, p<0.05, in paraesthesia-type pains (at light contact) - F=3.8, p<0.05, t=3.8, p<0.05. Much fewer changes were observed for other types of pain. Thus, it was not possible to confirm a significant change in burning pains over the exposure course (t=1.4, p>0.05, F=0.66, p>0.05); in pains accompanied by numbness (F=1.6, p>0.05, t=1.96, p>0.05); in pains when exposed to hot or cold objects (F=1.23, p>0.05, t=2.2, p>0.05); in pains resembling an electric shock (t=2.2, p<0.05, F=1.9, p>0.05).

The impact of the combined effects of «Almag-02» and «Magofon-01» on the pain syndrome severity was also assessed using one-way ANOVA test. The statistical data for the index and placebo groups were assessed at the end of the course of exposure. The maximum pain intensity indicator over 4 had been significantly affected by the «physiotherapeutic exposure» factor (F=4.8, p<0.01), and the level of pain intensity in the index group was lower (p<0.05). An equivalent pattern was observed as pertaining to the indicator «maximum pain intensity over the past 4 weeks»: F=5.44, p<0.01, and the intensity itself in the index group was significantly lower (t=2.7, p<0.05). The most pronounced effect in terms of the «physiotherapeutic exposure» factor was demonstrated by the indicator «character of pain sensations»: F=38.2, p<0.001, t=6.06, p<0.01. With regard to the changes in certain types of pain under exposure to the devices, we were only able to demonstrate a statistically significant effect pertaining to stabbing pains - F=3.64, t =2.3, p<0.05. Other types of pain, although they tended to have a higher reduction rate as compared to the placebo group, failed to show statistical significance to confirm this trend. Thus, it was not possible to confirm the significant effect of physiotherapeutic exposure on burning pains (t=0.28, p>0.05, F=0.08, p>0.05); on pains accompanied by numbness (F=2.41, p>0.05, t=1.6 p>0.05); on pain when exposed to hot or cold objects (F=1.64, p>0.05, t=1.34, p>0.05); on pains resembling an electric shock (t=1.1, p<0.05, F=1.47 p>0.05); on pains of paraesthesia type (at light contact) - F=0.23, p>0.05, t=0.61, p>0.05; as well as on pain during palpation (F=1.69, p>0.05, t=1.16, p>0.05).

When assessing changes in blood pressure (BP) in patients with dorsopathies over the treatment course, positive changes were observed only in the index group of patients. In the index group, systolic pressure had significantly reduced over the course of treatment (from 139.8±5.44 to 120.6±4.58 mmHg; t=3.64, p<0.01), with the degree of influence of the «therapeutic effect» factor being statistically significant (F=14.5, p<0.001). During the course of treatment in the index group, significant impact on diastolic blood pressure (DBP) was observed: a decrease in DBP from 82.8±4.24 to 76.2±4.44; t=3.67, p<0.05; F=3.2, p<0.05.

The placebo group hardly experienced any positive effect of the exposure course under the criterion of blood pressure reduction. Thus, the systolic pressure (SBP) over the treatment course remained virtually unchanged (from 137.1±7.24 to 138.6±6.11 mmHg; t=0.19, p>0.05), with the degree of influence of the «therapeutic effect” factor being statistically insignificant (F=0.01, p>0.05). DBP in the placebo group demonstrated virtually no effect over the treatment course: DBP changed from 72.4±5.04 to 80.8±7.90; t=0.68, p>0.05; F = 0.64, p> 0.05. When assessing the impact of the combined course exposure to «Almag-02» and «Magofon-01» devices on the blood pressure profile, certain patterns were identified. The statistical data in the index and placebo groups were assessed at the end of the exposure course. The SAD indicator experienced significant influence by the «physiotherapeutic effect” factor (F=7.75, p<0.01), and the SAD level in the index group was significantly lower (t=3.03, p<0.05). A similar pattern was observed as pertaining to DBP, although it did not reach a statistically significant level: F=1.71, p<0.05, while the DBP level in the index group was lower than in the placebo group (80 versus 76 mmHg, t=1.17, p>0.05).

The cost of medications and magneto-therapy (PMF) procedures in the index group of patients who were using fully-functioning «Almag-02» and «Magofon-01» devices (n=10) amounted to 4,610 rupees, 461 rupees per patient. In the group of patients receiving exposure to placebo devices (n=10), the medication costs (the cost of the procedures performed with placebo devices was not taken into account) amounted to 7,025 rupees, 702.5 rupees per patient. Based on these calculations, it can be concluded that, even taking into account the cost of services for conducting magneto-therapy in the index group, the cost of medicines and procedures per patient was 2,415 rupees (34.37%) less than the cost of drugs alone in the placebo group.

Conclusion

Thus, the prospective randomized blind, placebo-controlled blind (for patients) study assessing the effectiveness of combined use of magneto-therapy devices ( «Almag-02» and «Magofon-01» ) for treating dorsopathies has revealed as follows:

• a significant positive effect on the quality of life by reducing the intensity of pain syndromes when using «Almag-02» and “Magofon-01” devices in the index group as compared to the use of placebo devices, with the highest effect confirmed as to stabbing pains;
• a significant effect of the combined use of «Almag-02» and «Magofon-01» devices on the reduction of blood pressure while treating dorsopathies, with the highest effect confirmed as to systolic blood pressure in the index group of patients;
• reduction in the duration of drug use from 17 days (in the placebo devices group) to 5 days (in the index group using «Almag-02» and «Magofon-01» devices), which enables cutting the expenses by 2,415 (34.37%) rupees during the course treatment of one patient in the index group, with a higher efficacy of treatment.

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