RU2323751C1 - Method of treatment of diabetic peripheral polyneuropathy - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention affects the extremity in the projection of damaged nerve towards the extremity's periphery, with use of the traveling magnetic field. The magnetic field has the induction 25-45 mTesla. The scanning frequency is 15-20 Hz. The distance (T) between the effecting solenoids is 0.15 1≤Т≤0.25 1, where 1 is for length of effect zone.

EFFECT: method terminates the subjective symptoms of diabetic polyneuropathy and reduces the sensor disturbances; the method also improves the conduction of peripheral nerves.

4 tbl, 1 ex, 1 dwg

Description

The invention relates to medicine, namely to endocrinology, neurology and physiotherapy, and can be used to treat peripheral neuropathy in patients with diabetes mellitus in hospitals and outpatient clinics. The method allows to stop the subjective symptoms of diabetic neuropathy, reduce sensory disturbances, improve the conductivity of peripheral nerves.

The basis of diabetic peripheral polyneuropathy (DPN) is damage to the nerve fiber as a result of its demyelination, leading to a violation of the spread of excitation and denervation. Medicines recommended for the treatment of DPN are expensive and require long-term use. In this regard, physiotherapeutic methods are widely used in the treatment of diabetic neuropathy. They have a direct effect on the damaged nerve and do not require significant economic costs.

A known method of treating demyelinating neuropathies by exposure to an electric field of ultrahigh frequency (EP UHF) on the lumbar or cervical thickening of the spinal cord and at the same time on the affected limb [A / c SU 1630837 A1, N.I. Strelkova et al., 1991].

The disadvantage of this method is the weak penetrating ability of EP UHF when exposed to deeply located nerves, this requires additional exposure to segmental zones. In addition, the thermal effect arising from the use of this physical factor limits its use in diabetes mellitus due to the risk of bleeding in the presence of microangiopathies.

A known method of treating polyneuropathy using magnetoelectrophoresis with benzohexonium on the cervical and / or lumbar thickening of the spinal cord and flexion / extensor surface of the lower leg [RF Patent RU 2045291 C1, Shiman A.G. et al., 1995]. In this case, the legs of the patient are introduced into the inductor - an electromagnet from the apparatus “AD MT-Magnipuls” and at the same time acted by a pulsed magnetic field. 2 hours after electrophoresis, Actovegin is administered and a bipolar pulse current is applied along the affected peripheral nerves. The disadvantage of this method is the complexity and duration of the procedure, the excess load on the patient obtained when exposed to 3 physical factors and 2 drugs as part of one procedure.

There is also a method of treating diabetic polyneuropathy, including the use of a low-frequency pulsed magnetic field on the affected limb in combination with exposure to the cervico-thoracic and lumbosacral segmental zones [RF Patent RU 2213588 C2, A. Musaev et al., 2003]. The disadvantage is the use of a static magnetic field, which contradicts the principle of optimality of the physiotherapeutic effect: the dynamic effect is better perceived by the body, since all processes in a living organism are dynamic [V.S. Ulashchik, I.V. Lukomsky. General physiotherapy - 2005 - 511 p.]. In addition, the applied magnetic field induction of 5-10 mT is insufficient to affect deeply located nerves, because the magnetic field induction decreases exponentially with distance from the surface of the emitter. According to the description of the authors, the necessary therapeutic effect is achieved with a combined effect on the affected limb and segmental zones. The procedure is carried out in 2-3 stages of 10-15 minutes: sequentially to the segmental zones and the affected limb, which significantly lengthens the session time and, like in the previous method, increases the load of physiotherapy on the patient.

The closest analogue (prototype) is a method for the treatment of diabetic polyneuropathy, including exposure to a traveling pulsed magnetic field by induction of 45 mT and a modulation frequency of 10-16 Hz on a limb in the projection of the affected nerve [N.V. Bolotova et al. Magnetotherapy in the complex treatment of diabetic polyneuropathy in children / Pediatrics. - 2006. - No. 2. - p. 56-61].

We first proposed a method for the treatment of diabetic peripheral polyneuropathy, including the effect of a traveling pulsed magnetic field on a limb in the projection of the affected nerve, different from the prototype in that the exposure is carried out towards the limb periphery with a magnetic field with an induction of 25-45 mT with a field scanning frequency in the range of 15- 20 Hz and the distance (T) between the acting solenoids 0.15 1≤T≤0.25 l, where l is the length of the impact zone. The exposure time is 15-20 minutes daily, a course of 10-15 procedures.

The advantage of the proposed method in comparison with the prototype is its higher efficiency, due to the fact that the impact on the affected nerve with a traveling pulsed magnetic field is carried out with a field scanning frequency of 15-20 Hz, corresponding to the normal speed of the pulse along the nerve fiber. The distance (T) between the acting solenoids of 0.15 l≤T≤0.25 l (l is the length of the zone of influence) allows you to position at least 5 solenoids on the limbs, which is necessary and sufficient for optimal physiotherapeutic action on the affected nerve. A significant advantage of the proposed method is the direction of movement of the traveling magnetic field to the periphery of the limb, that is, along the innervation of the limb. It also enhances the effect on the distal nerve, most often affected by diabetic polyneuropathy.

The method is as follows (drawing): a magnetic field emitter (3) with a length of 25-30 cm with integrated solenoids is laid on the limbs (1) along the projection of the affected nerve: on the back surface of the lower leg and / or on the front surface of the lower leg. Solenoids (2) are located linearly inside the emitter (3). The distance (T) between two adjacent solenoids can vary in the range of 0.15 l≤T≤0.25 l. With a value of l = 30 cm (the length of the lower leg of a person of medium height), the distance T is in the range of 4.5 cm ≤T≤7.5 cm, which makes it possible to technically implement the method with at least 5 solenoids on the lower leg. The impact is carried out by a traveling pulsed magnetic field (BIMP) by induction of 25-40 mT in the direction to the periphery of the limb, that is, along the innervation of the limb. In this case, the field scanning frequency is set to a multiple of normal values of the speed of the nerve impulse, namely 15-20 Hz.

To ensure the principle of resonance effects, it is necessary to select the frequency of scanning the magnetic field corresponding to the normal speed of the nerve impulse - 50-60 m / s. Let us explain the correspondence between the speed of the impulse conduction along the nerve fiber and the scanning frequency of the magnetic field.

By definition, 1 Hz is one oscillation in 1 second. (1 Hz = 1/1 sec).

In our case, we are talking about the frequency of scanning a magnetic field. Therefore, in 1 sec, a complete cycle of the field’s movement along the emitter (from the first solenoid to the last) takes place, that is, the magnetic field travels a distance of 0.3 m, which corresponds to a scanning frequency of 1 Hz.

With normal conductivity of the nerve fiber, a nerve impulse travels for 50 m in 1 second, which corresponds to the desired scan frequency “X”. Based on this, you can make the proportion:

0.3 m - 1 Hz

50 m - X Hz,

X = (50 m × 1 Hz) / 0.3 m; X = 166.7 Hz

Thus, the scanning frequency of the magnetic field corresponding to the normal speed of the pulse 50-60 m / s is 166.7-200 Hz

Technically, at a speed of 166-200 Hz, it is difficult to provide the necessary induction in the solenoids due to the presence of transients in inductive circuits and the occurrence of EMF (electromotive force) of self-induction. In order to maintain the required value of magnetic induction, it is required to reduce the indicated frequency by 10 or more times.

So, the empirical choice of frequency range seems rather complicated. In order to determine the optimal exposure parameters, clinical studies were conducted under various modes and in different frequency ranges of the magnetic field.

112 patients with DPN were examined. The age of the patients is 10-35 years. All patients suffered from type I diabetes mellitus for 1-10 years and had a complication of distal peripheral sensory-motor polyneuropathy.

At admission, patients complained of pain in the legs and paresthesia, less often a feeling of numbness, burning in the lower extremities. All examined patients showed sensory disturbances in the form of a disorder of temperature (93%), pain (83.2%) and tactile sensitivity (9%), a decrease in Achilles (60%), and knee (30%) reflexes. Assessment of the severity of DPN was carried out on a scale for assessing subjective (TSS, NSS) symptoms and objective (NDS) symptoms, as well as the results of electromyography (EMG) of the lower extremities. Diabetic polyneuropathy of stage 1B was diagnosed in 12 patients, stage 2A in 56, stage 2B in 44 patients.

At the first stage of the study, the optimal frequency of exposure to a traveling pulsed magnetic field was selected in the treatment of patients with diabetic peripheral polyneuropathy. To this end, 56 patients were divided into 4 subgroups of 14 people. In the first subgroup, exposure was carried out with a field scanning frequency of 1-5 Hz, in the second - 5-10 Hz, in III - 10-15 Hz, in IV subgroup - 15-20 Hz.

A further increase in the frequency of scanning the field is impractical, since it will approach the natural carrier frequency of the solenoid.

When evaluating the results of treatment received the following.

In groups II and IV, already on the 4th – 6th day of treatment, patients noted a significant relief of subjective symptoms until they completely disappeared by the 8–9th procedure (Table 1).

When assessing objective symptoms after 10 sessions from the start of treatment, improvement and restoration of tactile sensitivity was found in 57% of patients of the II subgroup and in 53% of patients of the IV subgroup, temperature - in 79 and 87% of patients, pain - in 74.5% and 76% patients of groups II and IV, respectively (table 2).

Table 1. The dynamics of subjective symptoms of diabetic peripheral neuropathy in children of groups I-IV during treatment with BIMP Treatment day Subjective sensations in points on the NSS scale group I group II group III group IV one 6.8 6.5 6.4 7.0 2 6.6 6.2 6.6 6.6 3 6.7 4.8 6.2 5.2 four 5,4 4.2 5.8 4.3 5 6.1 4.2 6.3 3,5 6 4.9 2.6 5,4 2,8 7 5.2 2.7 5.2 3,1 8 4.0 2.2 4.3 2.2 9 3.8 1.8 3.0 2.0 10 3.2 2.2 2.9 1.4

Table 2. Dynamics of sensory disturbances in patients with DPN under the influence of a magnetic field in various frequency ranges (n = 56) Sensitivity type The number of patients with DPN with improvement and restoration of sensitivity,% I II III IV Temperature 65.0% 79.0% 61.0% 87.0% Painful 60.0% 74.5% 66.4% 76.0% Tactile 28.0% 47.0% 31.0% 43.0%

In groups I and III, a decrease in subjective symptoms was noted only by the 7th-9th session and was less significant compared with the two previous subgroups. So, by the 10th session, the average score on the NSS scale in group III was 2.9 points, while in group IV - 1.4 points, in group II - 2.2 points; confidence factors between groups III and IV p <0.05, between groups III and II p <0.01.

When testing sensitivity, improvement and restoration of tactile sensitivity was observed in 28% of patients of group I and 33% of patients of group III, temperature - in 65% and 61% of patients, pain - in 60% and 66.4% of patients of groups I and III, respectively (Table .2).

The final EMG indices in subgroups I-IV did not have statistically significant differences, however, in the II and IV subgroups, the change in the speed of the pulse and the amplitude of the M response was more significant than in the other two subgroups.

Thus, the dynamics of subjective and objective indicators as a result of magnetotherapy was most pronounced when using the BIMP frequency ranges of 15-20 Hz, apparently multiple of normal values of the speed of the impulse along the nerve.

In the manufacture of the solenoids used to implement the method, it was necessary to calculate the distance (T) between two adjacent inductors. It was experimentally established that for optimal dynamic action on the affected nerve, magnetic field inductors should be located along its projection in an amount of at least 5. If the impact zone is taken by us for 0.3 m, then 6 inductors can be linearly located at a distance of 6 cm from each other with a jump period of 0.2 × l, where l is the length of the impact zone. When changing the length of the zone of influence, the distance between the solenoids can vary in the range of 0.15≤T≤0.25

A prerequisite for conducting magnetic therapy is the selection of the optimal magnitude of the magnetic field induction. The magnetic field induction decreases exponentially with distance from the surface of the emitter, that is, when exposed to the body determines the depth of penetration of the magnetic field into the tissue. To determine the optimal value of magnetic field induction in the treatment of diabetic neuropathy of the lower extremities, 3 groups of patients of 20 people were selected. All groups were treated with a running pulsed magnetic field with a frequency of 15-20 Hz. In the first group, they were exposed to a magnetic field with induction of 5-14 mT, in the second - 15-24 mT, in the third 25-40 mT. The results were evaluated according to electromyography before treatment, after 3 and 10 procedures. EMG parameters of patients of the three groups are presented in table 4.

Table 4. Comparative results of treatment of DPN as a result of exposure to a magnetic field of various induction according to electromyography. EMG score I group II group III group 5-14 MT 15-24 MT 25-40 MT Ref. 3 day 10 day Ref. 3 day 10 day Ref. 3 day 10 day M answer mV: 1.65 ± 0.1 1.78 + 0.1 2.7 ± 0.1 1.8 ± 0.1 2.1 + 0.07 3.0 ± 0.05 1.7 ± 0.1 2.56 + 0.1 3.4 ± 0.1 * N.peroneus 1.8 ± 0.1 2.6 + 0.3 4.0 ± 0.2 1.7 ± 0.12 2.8 + 0.09 4.3 ± 0.1 1.8 ± 0.09 3.1 + 0.05 4,5 ± 0,07 n.tibialis RL, m / s N.peroneus 4.4 ± 0.5 4.2 + 0.4 3.7 ± 0.8 4.8 ± 0.41 4.3 + 0.4 3.3 ± 0.7 4,5 ± 0,7 3.9 + 0.6 3.2 ± 0.8 * n.tibialis 3.6 ± 0.8 3.5 + 0.7 2.9 + 0.1 3.8 ± 0.8 3.5 + 0.5 2.5 ± 0.15 3.6 ± 0.8 2.78 + 0.4 2.5 ± 0.3 SPI, m / s N.peroneus 38.2 ± 2.0 37.8 ± 2.1 43.2 ± 2.8 37.4 ± 1.8 41.2 ± 1.6 43.7 + 2.6 36.8 ± 1.1 46.6 ± 1.5 54.2 ± 4.0 * n.tibialis 35.9 ± 1.7 36.2 ± 1.8 43.5 ± 2.1 35.9 ± 1.7 37.8 ± 1.3 44.8 ± 2.5 35.9 ± 1.7 47.5 ± 2.1 54.8 ± 2.8 * * - p <0.05

It can be seen from the table that an increase in the magnetic field induction to 25–40 mTl improved the results of magnetotherapy. This is due to an increase in the depth of penetration of the magnetic field into the tissue and the possibility of a direct effect on the affected nerve. A further increase in the magnetic field induction is impractical because according to published data, with the induction of a field of more than 50 mT, tissue respiration is suppressed and adaptation reactions become pathological.

Thus, we have established the optimal parameters of a traveling pulsed magnetic field for influencing a limb in diabetic peripheral polyneuropathy: field scanning frequency of 15-20 Hz, magnetic induction 25-45 mT; the distance (T) between the two acting solenoids was calculated taking into account the length of the impact zone (1) and amounted to 0.15 l≤T≤0.25 l.

To assess the effectiveness of the claimed method, 56 patients with DPN were treated, including exposure to a traveling pulsed magnetic field with an induction of 25-45 m T moving toward the limb periphery with a scanning frequency of 15-20 Hz, the distance (T) between the acting solenoids corresponded the interval of 0.15 l≤T≤0.25 l, where l is the length of the impact zone. The treatment results were evaluated in comparison with the indicators of sensitivity and nerve conduction obtained during treatment by the method of the prototype (data presented in the journal Pediatrics. - No. 2. - 2006). Comparative characteristics of the results of treatment of patients according to the claimed method and the method of the prototype are presented in table 3.

Table 3. Comparative evaluation of the results of treatment of patients with DPN when exposed by the prototype method and the proposed method sign I group II group The treatment according to the proposed method Treatment according to the prototype method Before treatment After treatment Before treatment After treatment Subjective sensations A) On a TSS scale, points 6.3 ± 0.33 2.3 ± 0.1 ** 6.6 2,4 B) According to the NSS scale, points 5.7 ± 0.28 2.2 ± 0.16 * 5.5 2,4 Objective symptoms NDS Scores 6.8 ± 0.2 3.9 ± 0.14 * 6.6 4.6 Electromyography data: M answer, mV: N.peroneus 1.8 ± 0.14 3.2 ± 0.11 * n.tibialis 2.2 ± 0.1 4.3 ± 0.2 ** 1.2 ± 1.5 2.5 ± 2.9 RL, m / s N.peroneus 4.6 ± 0.23 3.3 ± 0.8 ** n.tibialis 3.9 ± 0.8 2.5 ± 0.3 * 5.1 ± 1.2 3.9 ± 1.1 SPI, m / s N.peroneus 36.3 ± 5.0 54.2 ± 4.0 ** n.tibialis 36.8 ± 4.2 54.8 ± 2.8 ** 36.3 ± 9.25 45.2 ± 4.85 * - p <0.05; ** - p <0.01

As can be seen from table 1, in group I patients there was a more pronounced decrease in subjective sensations and objective symptoms compared with patients of group II who were treated according to the prototype method. Electromyography indicators also showed a significant increase in the amplitude of the M response and the speed of the nerve impulse, and a decrease in residual latency. It was noteworthy that according to the EMG data of group I patients, equally significant changes were obtained both in terms of the tibial nerve and n.peroneus, which has a deeper location. Statistical processing of the results of the study showed that in group I of patients receiving magnetotherapy according to the claimed method, the treatment efficiency was on average 1.46 times higher.

The following are examples of specific uses of the claimed method.

Example 1

R. girl with a diagnosis of Type 1 diabetes mellitus, a period of metabolic decompensation. Complications of the underlying disease: Diabetic peripheral sensory-motor polyneuropathy 2 stage B. Sick type 1 diabetes for 6 years.

Upon admission, she complained of increased fatigue in the legs, pain in the legs, numbness, burning sensation in the feet and legs. At the initial examination, there is a decrease in all types of sensitivities by the type of “socks”. Achilles reflexes are reduced, the knee reflexes are preserved. The quantitative assessment of subjective symptoms on the TSS scale was 6.0 points, on the NSS scale - 5.6 points, objective signs on the NDS scale - 6.7 points. According to electroneuromyography, the amplitude of the maximum M-response of n.peroneus was 1.8 mV, n.tibialis was 2.0 mV. There was a decrease in the speed of the pulse along n.peroneus to 39.4 m / s, n.tibialis to 35.1 m / s. The increase in residual latency was determined by n.peroneus 4.4 m / s, n.tibialis - 4.0 m / s.

The patient underwent 10 procedures of exposure to a traveling pulsed magnetic field with an induction of a magnetic field of 25-40, with a field frequency of 15-20 Hz. After the course of treatment, a marked improvement in subjective sensations, almost complete disappearance of sensitive disorders was clinically observed. Assessment of subjective symptoms decreased: on the TSS scale to 2.3 points, on the NSS scale - 2.2 points. The quantitative assessment of objective signs on the NDS scale decreased slightly - up to 3.8 points.

Repeated electromyography indicators also indicated a significant increase in the amplitude of the M response for n.peroneus to 3.3 mV, for n.tibialis to 4.1 mV and the speed of the nerve impulse for n.peroneus to 54.1 m / s, for n .tibialis - 54.8 m / s, a decrease in residual latency according to n.peroneus to 2.8 m / s, according to n.tibialis to 2.6 m / s.

The result of treatment is a significant improvement in clinical and neurophysiological parameters.

Based on clinical studies and the examples cited, we can conclude that the dynamic action of a traveling pulsed magnetic field on a limb with diabetic peripheral neuropathy is more effective and allows you to increase the speed of a nerve impulse by an average of 1.5 times compared with a static effect (an increase in STI is only on 10%). The best treatment results were obtained using field scanning frequencies in the range of 15–20 Hz with a magnetic induction of 25–40 mT.

Claims (1)

A method of treating diabetic peripheral polyneuropathy, including the action of a traveling magnetic field on a limb in the projection of the affected nerve, characterized in that the effect is carried out in the direction of the limb periphery by a magnetic field with an induction of 25-45 mT, with a field scanning frequency in the range of 15-20 Hz and a distance ( T) between the acting solenoids 0.15 l <T <0.25 l, where l is the length of the impact zone.