Appraisal of treatment procedure tolerance
Appraisal of electrotherapy safety
Appraisal of electro-stimulator operational safety
Therapy was performed on 17 patients: 12 women and 5 men ranging from 21-68 years of age
Condition:
* 9 persons suffering from osteochondrosis of various spine sections with neurological presentations
* 3 persons suffering from arthrosis deformans of large joints
* 5 persons suffering from soft tissues contusion, ligament strains
Procedure:
Treatment was applied directly on the pain area
The relevant spine segments
The acupuncture and trigger points.
During the whole period of examination, neither patient suffered aggravation. More than in 80% of cases, positive dynamics was revealed in the form of regress of pain, decreasing of edema, increasing of motor activity and improvement of state of health. All cases revealed good tolerance of electro-stimulation.
So, using of electro-stimulator is rather effective in therapy of locomotor apparatus diseases and acute injuries (contusion, strains). Due to portability and easy operation, electro-stimulator may be applied both in special departments or rooms and at home under supervision of a physician.
Opinion on the results of clinical trial:
Microprocessor-based eiectro-neuro-stimulator for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with light and audible indication SCENAR, on Biologically Active Points and Biologically Active Zones, presented for testing corresponds to its medical purpose. Electrotherapy procedures tolerance is satisfactory. No negative secondary reactions or complications are revealed. The Electro-stimulator operation is reliable; its appearance corresponds to modern requirements. The product may be used both as auxiliary and main facility in locomotor apparatus diseases treatment, acute injuries (contusions, strains), pains in ambulances. Due to portability and easy operation, the device may (upon doctor's consulting) be applied at home according to its operation manual.
Conclusion:
Microprocessor-based eiectro-neurostimulator for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with light and audible indication SCENAR, on Biologically Active Points and Biologically Active Zones, developed by NTK ALS and Coloyara-2000 (Moscow), may be recommended to the special committee for devices and apparatuses applied for express diagnostics of organism functional condition using physiological indications of reflex zones and biologically active points and for reflexo-therapy on zones and biologically active points of the Committee for New Medical Technology of the Ministry of Health of the Russian Federation to allow its production and use in medical practice.
Approved:
Signature: Karpeev A.A.
19/09/2003
Department No. 169 of Federal Administration for Medical and Biological Extreme Problems under the Ministry of Health of the Russian Federation
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Clinical Trial:
SCENAR using a prototype microprocessor-based electro-neuro-stimulator were used for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with light and audible indication, on Biologically Active Points and Biologically Active Zones, Represented by NTK ALS and Coloyaro-2000 (Moscow).
On the grounds of resolution of the expert special committee for devices and apparatuses applied for express diagnostics of organism functional condition using physiological indications of reflex zones and biologically active points and for reflexotherapy on zones and biologically active points of the Committee for New Medical Technology of the Ministry of Health of the Russian Federation, to perform medical testing (minutes No. 5 dated 14.02.2003), Medical Sanitary Department No. 169 of Federal Administration Medbioextrem performed clinical trial of the prototype of electro-neuro-stimulator SCENAR, that had successfully passed technical testing in GUN VNIIIMT of the Ministry of Health (Certificate ATNLO 009.3070 dated 28.07.03).
Trial was performed in cardioiogic consultative diagnostic therapy center and physio-therapeutic division of Medical Sanitary Department No.169.
According to the request of the developers, the adaptive compact universal seif-controlling electro-stimulator SCENARÂ (hereinafter referred to as the Apparatus) is portable and is designed for work both at home and in treatment-and-preventive institutions.
The apparatus is a microprocessor-based controlling device that provides for contact operation with electric impulses with adjustable frequency, amplitude and modulation on biologically active points and zones. The main modes of work of the apparatus:
a) Automatic: Duration of operation on each skin area and settings are fixed automatically
b) Perpetual: Duration of operation on each skin area and settings are fixed by the operator
c) Searching: A special mode for searching of areas of exposure and treatment according to preset criteria.
In accordance with the program of the trials, 24 patients were treated using the electro-neuro-stimutator:
* 6 of the said patients suffered from spread osteochondrosis in acute phase with radicular pains of various topography and intensity
* 3 patients suffering from Acute Cerebral Circulatory Insufficiency (ACCI) with consequences of ischemic
* 2 patients are hemorrhagic
* 1 stroke patient in the phase of late rehabilitation
* 7 patients with soft hypertensia, 3 patients with neurocirculatory asthenia of hypotonic type
* 5 patients with ischemia; anginaof effort (II-III functional class)
Age composition of the examined persons from 18 to 64. Composition by sex: 44% - male and 56% - female
All the patients passed clinical instrumental examination and biochemical blood analysis proving the established diagnosis according to international classification of diseases (ICD).
Examination included:
* electrocardiographic monitoring at rest
* bicycle ergometry
* daily electrocardiographic and arterial pressure monitoring
* echocardiograph, ultrasonic and rheographic investigation of peripheral vessels
electro- and rheoencephalography
* gastroscopy
* ultrasonic investigation of inner organs
* external breathing function
* computer tomography and magnetic resonance tomography
* protein
* lipid and enzyme blood profile
* consultation of specialists on all diseases investigated
Treatment:
Treatment of patients with the apparatus and appraisal of efficiency thereof were performed in accordance with the operation manuals, as well as publicly known recommendations published, and depending on pathological syndrome and the purpose of treatment.
Upon electro-neurostimulation, all groups of patients revealed clinical improvement of condition. The group of patients with ACCI revealed muscular tonus correction, muscle strength and movement amplitude increasing. Patients with pain syndrome showed evident analgesic effect occurring during the procedure and remaining for a long time after the procedure. Ail patients of the said groups revealed positive effect of the treaty by the end of the therapy course.
The group of patients suffering from angiopathy (hypotonia, hypertonia), upon electro-neuro-stimulation with the apparatus as a part of complex therapy, also revealed positive changes in the clinical course of the disease with normalizing of arterial pressure.
No complications have been revealed in the course of applying of the apparatus with all group of patients.
So, medical (clinical) trial of microprocessor-based electro-neuro-stimulator for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with light and audible indication SCENAR, on Biologically Active Points and Biologically Active Zones, showed that the clinical effectiveness of the apparatus is mostly evident with patients suffering from pain peripheral syndrome.
Due to easy operation of the apparatus, performance of the therapeutic procedure by the medical personnel showed no difficulties, training lasts for a few minutes. The display depicts the dynamics of diagnostic and therapeutic process.
The apparatus is principally new and has no analogues worldwide; it allows to determine (in case of various pathologic processes) the initial condition of the patient according to the canons of the traditional oriental medicine (TOM), as well as to perform electrotherapy of various diseases via biologically active points and zones.
Critical remarks on the apparatus are not essential and were eliminated by the developer during medical trial.
Conclusion:
Medical (clinical) trials of the microprocessor-based electro-neuro-stimulator for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with fight and audible indication SCENAR, on Biologically Active Points and Biologically Active Zones, represented by NTK AlS and Coloyaro-2000, Moscow, showed that it is principally new apparatus having no analogues for express diagnostics, electrotherapy and appraisal of the results of treatment according to the canons of the traditional oriental medicine.
Technical characteristics correspond to the requirements set forth in the technical documentation.
Apparatus SCENAR may be recommended for serial production for implementation of the same into wide clinical practice.
Approved:
Chief of Medical Sanitary
Signature VS. Oldakovski
Seal: Federal Administration for Medical and
Biological Extreme Problems
under the Ministry of Health of the Russian Federation.
Medical Sanitary Department No. 169
Person in charge of the trials:
Chief of the cardiology consulting, diagnostic and
Treatment center of FU Medbioextrem
Doctor of medical sciences, professor
I.N. Vozovikov
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION RUSSIAN STATE MEDICAL UNIVERSITY DEPARTMENT OF NEUROLOGY AND NEURO-SURGERY
Municipal Clinical Hospital 1,
117049, Moscow, Leninski pr. 8, cor. 8;
No. A2/03/147
Report:
on Clinical Trials of microprocessor-based electro-neuro-stimulator for operation of bipolar impulses with adjustable amplitude, frequency and modulation, with light and audible indication SCENAR, on Biologically Active Points and Biologically Active Zones.
Apparatus SCENAR (hereinafter referred to as the device) is microprocessor-based controlled generator of bipolar electrical impulses with adaptable amplitude, frequency and modulation, and is designed for contact operation on biologically active points and zones.
Between 29 July 2003 and 08 October 2003, medical trials of apparatus SCENAR were performed at the Department of Neurology of the Russian State Medical University (RGMU), Faculty of Advanced Medical Studies the said apparatus had been developed and made by Cofoyaro-2000 and the Scientific Engineering Company ALS, Moscow.
The total number of procedures performed is 290. Operating time - 126 hours. No failures occurred.
Results of Clinical Trials:
29 patients with acute and chronic pain syndrome of able-bodied age (27-54 years) were examined.
The patients suffering from acute pain syndrome (visit after 2-3 days), including: lumbago - 4, cervical pain syndrome - 1, radicular syndrome - 3, trigeminal neuralgia - 2 (female -4, male-6). In case of acute pain syndrome the patients were treated with basic therapy: nonsteroid anti-inflammatory medicines; in case of trigeminal neuralgia - anticonvulsants.
Patients with chronic pain syndrome (disease duration from 1 to 4.5 years) 9 patients (female 12, male -7), dorsopathy, including: with secondary radicular syndrome of cervical spine 4, lumbar spine - 14. 12 patients, during the year, were hospitalized once in neurological centers, the rest patients received outpatient care.
Pain intensity was appraised according to VAS scale. The average value by groups: for patients with acute pain was 9.2+0.6; for patients with chronic pain 6.4 + 0.4. After a single procedure the pain intensity value for patients with acute pain was 6.8+0.5; for patients with chronic pain 5.2 + 0.3.
After a course of treatment (10-32 procedures), 8 patients revealed complete pain removing. In case of chronic pain syndrome after the course of treatment pain syndrome intensity decreased to 2.1+0.2 according to VAS scale.
In order to obtain objective appraisal of damage in case of compression of spinal radices by intervertebral disks hernia EMG and ENMG researches were used prior to and after treatment. Improvement was revealed: increasing of velocity of impulse conduction via radicular nerve segment, correlating with clinical improvement; increasing of amplitude of bio-potentials of the relevant muscle.
SCENAR clinical trial evidences product conformance to medical requirements shown in the requirement specification.
Opinion on the results of clinical trial:
The product conforms to the requirements of medical practice and its functional purpose. The device is easy in operation. Technical esthetics and color design is good. No inconvenience construction and deficiencies were revealed during the trial.
Apparatus SCENAR fully corresponds to its medical intent, its application allows to accelerate treatment of pain syndrome in case of various diseases, including neurological profile.
Contraindications for use of the apparatus are those that are commonly applied in electric impulse therapy, including individual intolerance.
Apparatus SCENAR may be recommended for quantity production for implementation of the same into wide clinical practice.
Approved by:
Chief of Advanced Medical Studies Faculty
Department of Neurology and Neurosurgery
Prof. Signature G.N. Avakyan
Ministry of Health of the Russian Federation.
Russian State Medical University
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