APPROVED General Director of ECOMED Research and Production Association S. A. Khvorostov /signature/ Seal

APPROVED Chairman of the Neurology Section at the Scientific Council of the Russian Federation Ministry of Health Protection, Head of the Chair of Neurology and Neurosurgery of the Russian State Medical University, Academician of the Russian Academy of Medical Sciences, professor E. I. Gusev /signature/ Seal September 12, 1995

R E P O R T
on clinical examinations of the autonomous electrostimulator of alimentary canal and mucosa for the patients with lumbosacral radiculitis

Responsible executor: senior researcher of scientific laboratory, Chair of Neurology and Neurosurgery, doctor of medical sciences

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N. V. Kazantseva

Initial application of the autonomous electrostimulator for direct indications (pathology of alimentary canal) unexpectedly revealed a high clinical efficiency and prolonged therapeutical influence in the case of chronic lumbosacral radiculitis. The analysis of pathogenetic mechanisms of exacerbation of lubosacral radiculitis indicates the changes in functional state of central regulatory formations of spinal cord with development of syndrome of vegetovascular distony. Appearance of relapsing painful syndrome is primarily caused for demyelinization of nervous fibers that is developed and retained due to nonspecific autoimmune inflammation and vegetative trophic disorders. Application of the autonomous electrostimulator is accompanied by pronounced stimulation of the central nervous system, normalization of immune reactions, and activation of nonspecific protection of an organism. We can suppose that the therapeutical influence of the autonomous electrostimulator in lumbosacral radiculitis should be accompanied by normalization of disorders in neuromotor system.

GOAL of this investigation was the study of clinical efficiency and mechanisms of the influence of the autonomous electrostimulator in a closed randomized test for the patients with prolonged exacerbation of lumbosacral radiculitis.

MATERIALS AND METHODS OF INVESTIGATIONS. Object of investigations. On the whole, we examined 20 patients with prolonged (one to three months) exacerbation of chronic lumbosacral radiculitis, including ten men and ten women. The patients were divided into two groups for carrying out the randomized investigations (application of the autonomous electrostimulator and placebo). Each group included five men and five women, who were comparable in pairs with respect to their age, degree and duration of disease. The average age of patients, who applied the capsules, was 46.2±2.6 years, the patients of the control group were 47.3±3.4 years old. Immediately after the control examination and in two weeks after, the patients in the morning swallowed on an empty stomach a capsule of the autonomous electrostimulator or a placebo (a de-energized capsule).

The examination was carried out under clinical or polyclinical conditions of observation over the patients on the background of traditional therapy, including analgesics, vitamins, physical therapy and excluding needle reflexotherapy. The neurological status was estimated in dynamics using a scale system. The scale and table for estimation of neurological symptoms were developed at the Chair (N. V. Kazantseva). In the initial state, the expression of neurological symptoms was 15.75±1.459 and 16.48±2.197 points in the test in the test and control groups, respectively.

METHODS OF INVESTIGATION. All the patients were subjected to electroneuromyographic investigation of lower limbs before application of the autonomous electrostimulator and in 30 days after. We performed the study of amplitude, duration, and latency of M-response, potential of action, afferent and efferent rates of pulse passage along n.tibialis and n.peroneus at the side of painful syndrome and the intact limb. The parameters of electroneuromyography in the initial state did not differ for the two groups.

RESULTS OF INVESTIGATIONS. Clinical and electroneuromyographic parameters in the test and control groups did not differ. However, even after application of the first capsule, the patients of the test group showed the tendency to significant regress of neurological symptoms, especially, decrease in the degree of painful syndrome, regress of symptoms of stress and loss of sensitivity. The patients with pronounced painful syndrome and rough neurological deficiency showed a noticeable regress after the second application of the autonomous electrostimulator. Seven patients of the test group showed regeneration of earlier disordered painful sensitivity of radicular type at the vulnerable side. The patients of the control group also showed subjective improvement of their state without significant regress of neurological symptoms, and no patient of the control group showed regeneration of radicular disorders of sensitivity during the treatment. After the therapeutical course, the results in the test group were as follows: six patients showed complete regress of symptoms, one patient showed significant regress, two patients showed moderate regress, and one patient had not significant dynamics. In the control group, significant regress of symptoms was observed only for one patient, four patients showed moderate regress, four patients had not noticeable regress, and one patient showed increase in neurological symptoms that was not caused by application of placebo. In our scale of estimation of neurological symptoms, the test group showed a reliable regress of neurological deficiency (P < 0.0001), while the positive dynamics in the control group was, on the whole, beyond statistical reliability (P > 0.1)

Table 1. Dynamics of neurological symptoms and electroneuromyographic parameters upon application of the autonomous electrostimulator by the patients with lumbosacral radiculitis

	Intact limb		Vulnerable limb
	before  treatement	after  treatement	before  treatement	after  treatement
N.Tibialis
Lat.  error ±	6.6  0.2	5.1  0.5	6.5  0.4	5.4  0.4
Long.  error ±	11.9  0.8	10.7  0.6	12.7  0.9	10.9  0.8
Am  error ±	1184.8  339.6	1577.5  284.2	1038.6  271.3	2487.1  393.3
Vm  error ±	38.2  2.1	43.7  1.0	36.6  3.2	45.2  1.9
PD  error ±	17.7  4.3	24.1  4.3	21.6  5.2	30.9  8.1
Vg  error ±	33.2  6.7	41.3  1.6	33.8  6.4	40.4  2.5
n.Peroneus
Lat.  îø. ±	5.2  0.6	4.2  0.3	6.0  0.5	4.3  0.4
Long.  error ±	11.8  1.0	11.6  0.8	12.7  0.6	10.7  0.5
Am  îø. ±	1217.0  231.4	1794.0  253.1	1096.9  251.2	1885.7  427.2
Vm  error ±	45.3  1.4	49.0  1.4	44.6  1.4	48.0  1.5
PD  error ±	3.5  1.8	15.8  3.4	2.6  1.7	20.8  7.7
Vg  error ±	16.3  10.3	46.2  2.9	16.4  12.4	40.8  6.5
	before treatment		after treatment
Clinic  error ±	15.8  1.5		2.9  0.8

Table 2. Dynamics of neurological symptoms and electroneuromyographics parameters upon application of the autonomous electrostimulator by the patients with lumbosacral radiculitis in the control group

	Intact limb		Vulnerable limb
	before  treatment	after  treatment	before  treatment	after  treatement
N.Tibialis
Lat.  error ±	5.7  0.3	5.2  0.3	5.8  0.5	5.2  0.3
Long.  error ±	11.4  1.3	10.9  1.0	11.3  1.4	10.1  1.1
Am  error ±	939.1  251.7	1556.2  361.7	1271.8  401.0	1227.8  297.1
Vm  error ±	40.9  2.3	48.2  3.5	39.5  2.9	42.1  2.7
PD  error ±	19.3  8.2	19.3  5.4	22.2  9.0	13.5  6.3
Vg  error ±	41.3  2.3	44.8  3.5	37.0  1.9	31.8  7.4
n.Peroneus
Lat.  error ±	4.6  0.4	4.7  0.3	5.0  0.3	4.2  0.4
Long.  error ±	10.2  1.0	9.2  0.7	10.5  1.0	10.3  0.7
Am  error ±	824.7  205.6	806.2  133.8	897.6  215,3	670.7  170.1
Vm  error ±	49.8  1.5	51.5  3.1	48.4  1.6	51.0  2.7
PD  error ±	8.3  4.5	14.3  4.4	20.3  10.1	13.0  7.1
Vg  error ±	30.9  13.1	60.9  6.5	26.8  8.2	39.9  7.3
	before treatment		after treatment
Clinic  error ±	16.5  2.2		13.0  2.4

An interesting peculiarity of the influence of the autonomous electrostimulator was regeneration of vegetative reactions, which were lost by the patients with lumbosacral radiculitis, namely, appearance of skin dermographism below lumbus and in the region of lower limbs. For the initial absence of this skin vegetative reactions, we observed even after application of the first capsule of the autonomous electrostimulator appearance of stable stretched white dermographism below lumbus of all the patients of the test group that indicated activation of sympathetic nervous system. For most patients of the test group, stretched white dermographism was replaced by normal pink dermographism in 2 or 4 weeks that indicated regeneration of normal vegetative skin reflexes that closed in the back columns of spinal cord and were earlier lost by these patients. Four patients of the control group showed unstable while dermographism in the region of lumbus in several days after application of the capsule of placebo; however, no regeneration of normal vegetative reactions was observed for this group of patients.

The analysis of results of electroneuromyographic investigations also enabled us to reveal the reliable changes in the parameters under investigation for the test group of patients. Unlike the control group, the test group of patients showed:

Certain decrease of overall parameters characterizing the time of pulse passage along the sensitive and motive nerves, while these changes in the test group were observed both at the vulnerable side and on the intact limb (Lat., Vm,).


The test group showed enhancement of M-response amplitude at the vulnerable side.


The test group showed increase or appearance (after the initial absence) and reliable increase of the rate of pulse passage along the sensitive fibers that was confirmed by clinical regeneration of radicular disorders of sensitivity for most patients of the test group.

DISCUSSION OF RESULTS. The reliable differences of results of investigations between the test and control group indicate the clinical efficiency of application of the autonomous electrostimulator for lumbosacral radiculitis. The particular selection of the patients with prolonged exacerbation of chronic lumbosacral radiculitis makes the obtained results still more valuable. The pronounced clinical effect of the autonomous electrostimulator on the background of degenerative changes caused by prolonged chronic disease of spine confirm vegetative and trophic influence of the autonomous electrostimulator. A sufficiently fast noticeable disappearance of stable neurological symptoms, primarily, of radicular disorders of sensitivity, indicates the neuroreflective effect of the autonomous electrostimulator. This effect is confirmed by changes in skin vegetative reflexes, i. e., appearance of stable stretched white dermographism at lumbus and below that indicated activation of sympathetic section of vegetative nervous system, which basic function is adaptive and trophic. The absence of weak expression of this reaction of the patients, who applied placebo, confirms the discovered influence of the autonomous electrostimulator on vegetative nervous system. The adaptive and trophic influence of the autonomous electrostimulator observed on the background of activation of sympathetic system displays itself in 2 to 4 weeks in appearance of earlier absent normal vegetative reactions below lumbus of most patients that seems to indicate the prolonged therapeutical effect of the autonomous electrostimulator observed in our preliminary investigations. This effect, in its turn, is a symptom of stable normalization of the functional state of vegetative nervous system and appearance of normal vegetative reflexes, which were absent for the patients with pronounced osteochondrosis of lumbosacral section of spine. This pronounced normalization of vegetative reaction promises prolonged therapeutical posteffect of the autonomous electrostimulator for lumbosacral radiculitis. Because the clinical effect and, primarily, regeneration of the lost sensitivity were observed immediately after application of the first or second capsule, while regeneration of other symptoms were observed gradually during 2 to 4 weeks. The presence of stable vegetative reactions in the form of stretched white dermographism indicates the activating effect of the autonomous electrostimulator on the tonicity of sympathetic nervous system.

Responsible executor: senior researcher of scientific laboratory, Chair of Neurology and Neurosurgery, doctor of medical sciences

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N. V. Kazantseva