CLINICAL EVALUATION REPORT · The structure of this report meets the requirements of MEDDEV Rev.4....

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CLINICAL EVALUATION REPORT

1 Summary

Title of report: Evaluation of the clinical data on the use of SCENAR devices for non-invasive

transcutaneous treatment for the purpose to relieve pain and manage pain-related pathologies.

Date of report: 19th July 2019

Objectives of the report: Еvaluate the safety and effectiveness of SCENAR devices through the

comprehensive analysis of current clinical research literature and state-of-the-art and show

compliance with SCENAR devices with the essential requirements of European Directive

93/42/EEC.

Name of devices: The devices are united into a series since their purpose, application,

mechanism of action, utilized materials, basic technical characteristics, functionality and

manufacturing processes are similar and these devices has a general name - SCENAR device.

Methodology: To evaluate the safety and efficacy of SCENAR devices the comprehensive analysis of current literature on clinical studies searched in scientific databases, conference papers and other sources including non-published clinical literature.

Summary: This report provides evaluation of clinical characteristics and safety of SCENAR

devices from the comprehensive literature search and analysis. This report is performed

according MEDDEV 2.7/1 revision 4.

In order to evaluate clinical performance and safety of SCENAR devices literature search and

clinical study identification based on defined search protocol is performed. Clinical literature is

analysed in connection with risk management documents and information materials on SCENAR

devices. Benefits and Side effects of the use of SCENAR devices are detected and risk/benefit

ratio is assessed.

Clinical analysis performed demonstrates SCENAR devices compliance with the essential

requirements of European Directive 93/42/EEC.

2 Scope of the clinical evaluation

This clinical evaluation is submitted to the MDD as amended by directive 2007/47/EC.

2.1 The proprietary name of the device

SCENAR device (further the Device).

2.2 Device classification

The Device is an active therapeutic device intended to administer or exchange energy

(Class IIa).

2.3 Name and Address of the Manufacturer

RITM OKB ZAO

99, Petrovskaya str., Taganrog, Rostov region,

347900, Russia

Tel/Fax: (8634) 62-31-79

E-mail: [email protected]

Web-site: http://www.scenar.com.ru

http://www.scenar.com.ru/

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2.4 Brief description of the medical device

All models SCENAR device consists of a small battery-powered, stimulating device that

generates electrical pulses , which are delivered via built-in electrode or lead wires to metal add-

on electrodes or self adhesive electrode that are attached to the surface of the skin.

SCENAR devices produce Asymmetrical Biphasic Pulse electrical currents of Frequency

15-350 Hz and a variety of pulse patterns (modes) including continuous, burst (intermittent trains

of pulses) and modulated amplitude and/or modulated frequency and/or modulated pulse

duration, and/or allow changing some parameters waveform (called 'Damping').

The Number of modes depends on concrete model of the SCENAR device, but waveform

and basic parameters (Phase Duration, Pulse Duration, Interpulse Interval) are always which are

the same for all models of SCENAR devices.

Produced SCENAR devices are listed in the Table 1.

Table 1

Device name Type/model/version Trade (alternative) names

CHANS-SCENAR CHANS-SCENAR RITMSCENAR Home

SCENAR Home

CHANS-01-SCENAR RITMSCENAR Sport

SCENAR Sport

SCENAR Pain Genie

RITMSCENAR Home Device

RITMSCENAR Gorfinkel

SCENAR Gorfinkel

CHANS-02-SCENAR RITMSCENAR Basic

SCENAR Basic

CHANS-SCENAR-M RITMSCENAR Home D

SCENAR Home D

CHANS-01-SCENAR-M RITMSCENAR Sport D

SCENAR Sport D

CHANS-02-SCENAR-M RITMSCENAR Basic D

SCENAR Basic D

SCENAR-NT SCENAR-1-NT (version 01) RITMSCENAR Pro Prime

SCENAR Pro Prime

SCENAR-1-NT (version 02.1) RITMSCENAR Pro Plus

RITMSCENAR Pro +

SCENAR Pro Plus

SCENAR Pro +

SCENAR-1-NT (version 02.2) RITMSCENAR Pro Optima

SCENAR Pro Optima

SCENAR-1-NT (version 02.3) RITMSCENAR Pro

SCENAR Pro

SCENAR-1-NT (version 03) RITMSCENAR Pro Essential

SCENAR Pro Essential

SCENAR-1-NT (version 01C) RITMSCENAR Pro Prime C

SCENAR Pro Prime C

RITMSCENAR Super Pro v.2

bioSCENAR Professional v.2

SCENAR-1-NT (version 02.1C) RITMSCENAR Pro Plus C

RITMSCENAR Pro + C

SCENAR Pro Plus C

SCENAR Pro + C

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SCENAR-1-NT (version 02.2C) RITMSCENAR Pro Optima C

SCENAR Pro Optima C

SCENAR Physio

SCENAR-1-NT (version 02.3C) RITMSCENAR Pro C

SCENAR Pro C

SCENAR-1-NT (version 03C) RITMSCENAR Pro Essential C SCENAR Pro Essential C

RITMSCENAR Expert

RITMSCENAR Expert C Add-on electrodes Face electrode

Comb electrode

Point electrode

Local electrode

Special Snail electrode

Bent point electrode

Double facial Pawns electrode

Double cosmetic electrode

Double ophthalmic Goggles electrode

Double facial Stamps electrode

Single ophthalmic Monocle electrode

Special double Pencils electrode

Large Comb electrode

Multi-purpose zonal electrode

2.5 Purpose

The Device is intended to relieve pain and manage pain-related pathologies.

2.6 Intended Use

SCENAR devices should be used by therapists, doctors and medical staff as well as by

non-medical home users for symptomatic relief and management of chronic, intractable pain or

as an adjunctive treatment for post-trauma acute pain.

2.7 Identification of organs, tissues or body fluids contacted by the device

Intact skin contact with device electrode

2.8 Precautions

Following general precautions are specified in the Instruction for use (IFU):

- This device should NOT be used on an individual who has a heart pacemaker or other

electrically powered implant fitted.

- Simultaneous connection of a patient to a HF surgical equipment may result in burns at

the site of the stimulator electrode and possible damage to the stimulator.

- Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy equipment

and mobile communicators may produce instability in the stimulator output.

- The device needs special precautions regarding EMC and needs to be installed and put

into service according to the EMC information provided in Annex in Operating Manual.

- As the current densities for electrode exceeds 2 mA r.m.s./cm2, the device requires the

special attention of the user.

- The device should not be used adjacent to or stacked with other equipment.

- The device NOT suitable for use in the presence of flammable anaesthetic mixtures with

air, oxygen or nitrous oxides.

http://www.scenar.degosite.ru/en/shop/accessoires/218/










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According to the IFU, the device should not be used in:

- overly sensitive individuals, including pregnant women;

- patients with cardiac pacemakers; - alcoholic intoxicated individuals; - patients with acute infection diseases.

2.9 Device Action

SCENAR devices generate low and medium frequency bipolar electric pulses. The method

of generating output pulses consists of two stages (phases). At the first stage the inductor is

connected to the power supply for some time. This stage is called ‘pumping’. During this stage,

the inductor accumulates energy for stimulation. At the second stage, the inductor is

disconnected from the power supply and in the circuit formed by the inductor and skin-to-

electrode capacitance the transient process begins. Stimulus energy equals to (and is limited by)

the energy accumulated at the first stage (pumping). Therefore the device is electrode short-

circuit resistant. The shape of the pulses dynamically varies with changing electrophysiological

characteristics of the skin (capacitance and resistance). The device does not utilize a conductive

media between the electrodes and the patient's skin because the conductive media drastically

decreases skin resistance and reduces its changes caused by electric stimulation.

In pain relief therapy, actual subjective sensations of the patient shall be considered, and

treatment zones shall be selected according to them. The device has a built-in electrode (not to be

fastened to the skin) for this purpose. Besides, the device has two stimulation dosing modes and

a mode for determining treatment zones.

2.10 Specifications

Specifications of SCENAR devices are given in Table 2.

Table 2

Parameter CHANS-SCENAR SCENAR-NT

Supply voltage 9 V

SCENAR-1-NT (version 01, 02.1,

02.2, 02.3, 03, 01C, 02.1C, 02.2C,

02.3C, 03C) - 4.0 to 6.4 V

RITMSCENAR Expert,

RITMSCENAR Expert C - 3.0 to 4.8 V

Maximum supply

current not more than 85 mA not more than 650 mA

Pulse waveform

Asymmetrical biphasic Asymmetrical biphasic

Amplitude of the

stimulating pulse

at a standard load

not more than 150 V not more than 150 V

Pulse frequency

CHANS-SCENAR, CHANS-

SCENAR-M - 90 Hz

CHANS-01-SCENAR, CHANS-

01-SCENAR-M - 14, 60, 90, 340 Hz

CHANS-02-SCENAR, CHANS-

02-SCENAR-M - 60, 90 Hz

SCENAR-1-NT (version 01, 02.1,

02.2, 02.3, 01C, 02.1C, 02.2C, 02.3C),

RITMSCENAR Expert, RITMSCENAR

Expert C - 15 to 350 Hz

SCENAR-1-NT (version 03, 03C) -

15, 60, 90, 350 Hz

Electrode type Embedded coaxial type stainless

steel electrode

Embedded coaxial type stainless steel

electrode

Dosed mode Yes Yes

Dosed mode

indication

LED or LCD display LCD display

Weight not more than 0.2 kg not more than 0.4 kg

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Parameter CHANS-SCENAR SCENAR-NT

Dimensions not more than 140x55x35 mm not more than 190x70x40 mm

Cable length (900 100) mm

2.11 Device design

The device has an upper cover, case with a built-in electrode and a battery cover. All

components except for the batteries are located on the printed circuit board inside the device’s

case. The device’s controls and visual indicators are located on the upper side of its case.

2.12 Used materials

Stainless steel – electrode, ABS – case.

2.13 Power supply

Alkaline batteries

2.14 Changes since last report

Since the preparation of the last report SCENAR B13.13 of 01-02-2019, the risk analysis

(SCENAR A6.14 Risk Analysis of 19-07-2019) was updated, but no changes were made in the

characteristics of the devices, so the repeated literature search was not conducted. In this report,

only a link to a document containing a risk analysis has been updated.

This report does not contain any information on equivalent devices because substantial

equivalence is not claimed in the report.

The structure of this report meets the requirements of MEDDEV Rev.4.

3 Clinical background

3.1 Brief history of the technology

Electric treatment is well-known and is being used since long time ago.

Galvanizing - is the impact of low-strength (50 mA) and low voltage (30-80 V) direct

current. Galvanization exists for 200 years.

The development of electrostatic generators in the eighteenth century increased the use of

medical electricity, although its popularity declined in the nineteenth and early twentieth century

due to variable clinical results and the development of alternative treatments [1].

In the 1950s P. Bernard offered the treatment with alternating current (diadynamic currents

therapy).

In 1963 it was offered to use sinusoidal currents with frequency 5000 Hz, modulated with

frequency from 10 up to 150 Hz (amplipulse therapy).

Electropulse therapy was developed basing on ‘The gate control theory’ by Melzack R.,

Canada, and Wall P., England, 1965 who provided a physiological rationale for electroanalgesic

effects [2].

Since the 1970s, Transcutaneous electrical nerve stimulation (TENS) has been widely used

for the treatment of acute and chronic pain [3].

In Practical implications there is a problem of 'adaptation' to electric signal - the effect goes

down with the lapse of time. In particular, is installed that, if the pulse amplitude of TENS is left

at the same level, the intensity of TENS will fade over time due to habituation [4].

For reduction of the influence of this problem on efficiency of the influence in SCENAR

devices during treatment the shape of the pulses dynamically varies with changing

electrophysiological characteristics of the skin.

Early 80-ies – the Company (now it is RITM OKB ZAO) designed the first device that

worked on the same principle – ENS-01 (EnergoNeuroadaptive Stimulator). Tests and clinical

datas proved its effectiveness.

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Later on, the method was improved and called ‘Self-Controlled EnergoNeuroAdaptive

Regulation’, and the device that implemented this method, correspondingly - ‘Self-Controlled

EnergoNeuroAdaptive Regulator’ – ‘SCENAR’ [5,6,7].

Main benefits of transcutaneous electrical stimulation are: minimum side effects compared

to pain medication, simplicity of use by non-professional users. There are indirect benefit of the

use of the Device in minimizing analgetic consumption due to pain relieving effect and therefore

minimizing risks associated with drug-produced side effects.

3.2 Types of users

The SCENAR device can be used:

- by home users as general pain-management option;

- by medical professionals, in ambulatory care for acute and chronic pain management;

- by medical professionals in hospital and ambulance to relieve acute pain syndromes at

pre-hospital stage and to treat post-surgical pain syndromes.

3.3 Treatment options

There are two operating modes in the device:

- subjectively-dosed mode, in which the time of treatment is regulated according to the

guidelines given in the IFU;

- individually-dosed mode, which regulates time of treatment for one spot/area

automatically. Visual and audio signals are used to indicate the end of a session.

The device can be used either with built-in electrode or with pluggable external electrodes

supplied by Manufacturer through external electrode jack.

3.4 Known hazards and side effects

Though no side effects were observed when using the Device or alternative devices, there

are known general precautions specific to TENS device group that are applicable to the Device.

Electrical stimulation should not be done in patients with

- undiagnosed pain (unless recommended by a medical practitioner);

- pacemakers (unless recommended by a cardiologist);

- heart disease (unless recommended by a cardiologist);

- epilepsy (unless recommended by a medical practitioner);

- pregnancy:

- first trimester (unless recommended by a medical practitioner);

- over the uterus;

- reduced skin sensation (to prevent electric burns)

Electrodes should not be placed

- over the carotid sinus

- on broken skin

- internally (mouth) (unless specially designed and clinically approved electrode and

treatment modes are used).

There was only minor side effects of TENS observed. Patients may experience skin

irritation beneath or around the electrodes. Some patients may experience intolerance with

electric stimulation sensations.

4 Device under evaluation

4.1 Type of evaluation

This clinical evaluation is done as evaluation of scientific literature currently available and

clinical investigations and PMCF made by the Manufacturer.

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4.2 Demonstration of equivalence

Substantial equivalence is not claimed.

4.3 Clinical data generated and held by the manufacturer

4.3.1 Instruction for Use

The Instruction for Use and the Operating Manual contain the full information which is

necessary for carrying treatment according indications specified in the Instruction for Use. The

Instruction for Use is in the Technical File.

4.3.2 Product literature

No additional product literature is shipped with device.

4.3.3 Data generated through clinical experience

Clinical data assessment is also based on the results of medical investigations that were

performed in compliance with the regulatory requirements of the Russian Federation, and not

those of Directive 93/42/ЕЕС.

The medical investigations were performed with the approval of competent regulatory

authorities for the purpose of SCENAR devices registration that permitted their use,

manufacturing and marketing in the Russian Federation ([8] - [17]).

These medical investigations were carried out in the period of time (1990 - 2013) when

their planning, performing and reporting according to GOST R ISO 14155 (ISO 14155) was not

required in the USSR and Russian Federation. Nevertheless, the results of these investigations

testify that they were performed in compliance with World Medical Association Declaration of

Helsinki. The medical investigations were performed at leading Russian medical academies and

institutes upon the initiative of the Minister of Health of the USSR and Russian Federation:

N.Burdenko Institute of Neurosurgery, USSR Academy of Medical Science (1990 , 1991),

Russian Academy of Medical Science (RAMN) (1993);

P.Anokhin Normal Physiology Research Institute, USSR Academy of Medical Science

(1990);

N.Priorov Central Research Institute of Traumatology and Orthopedics (abbreviated as

N.Priorov CITO), Ministry of Public Health of the USSR (1990, 1991), Ministry of Public

Health of Russia (1993, 1997);

7th Central Military Aviation Research Hospital (7 CVIAG) (1991);

Central Research Institute of Reflexotherapy, Ministry of Public Health of the USSR

(1991);

Research Institute of Pediatrics and Children’s Surgery, RSFSR Ministry of Public Health

(1990, 1991), Ministry of Public Health of Russia (1993, 1997);

I. Sechenov Moscow Medical Academy (I. Sechenov MMA) (1997, 2001);

Research-and-Production Center of Traditional Medicine and Homeopathy, Ministry of

Public Health of the Russian Federation (NPC TMG MZ RF) (2001);

Moscow State Medical and Stomatological University (MSMSU) (2001, 2003, 2004);

Institute of Reflexotherapy, Federal Scientific Clinical and Experimental Center of

Traditional Diagnostic and Treatment Methods, Ministry of Public Health of the Russian

Federation (FNKEC TMDL MZ RF) (2003, 2004);

Russian Medical Academy of Post-Graduate Education (RMAPO) (2003, 2004).

Saint Petersburg Clinical Hospital of the Russian Academy of Sciences (RAS) (2013).

All cases showed beneficial effects of treatment, device fitness for use, satisfactory tolerance of

electrotherapy sessions, no side effects and complications, usability and reliability. They also

showed that SCENAR devices can be used for monotherapy as well as combined with a basic

pharmacotherapy and other treatments.

Clinical data generated and held by the Manufacturer is summarized in Table 3.

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Table 3

# Report title

1 Clinical evaluations under local regulations

R1 Medical Device Clinical Trial Evaluation Report as of November 27, 2014. SCENAR-

NT Transdermal Electrostimulators in six versions with accessories (Appendix 3) by

TR 9444-015-05010925-2004 Manufactured by: RITM OKB ZAO, Russian Federation

(Акт оценки результатов клинических испытаний медицинского изделия от «27»

ноября 2014 г. «Электронейростимуляторы чрескожные «СКЭНАР-НТ» в шести

исполнениях с принадлежностями (Приложение 3) по ТУ 9444-015-05010925-

2004» производства: ЗАО «ОКБ «РИТМ», Россия)

2 Clinical data obtained through PMCF procedure

C1

Tarakanov A.A., Efremov V. V., Nelassov N.J., Tarakanov V.A., Karkoshko T.A.,

Erofeeva A. V. Transdermal neurostimulation in dorsalgia patients at pre-hospital stage

of medical care // Abstracts of a joint venture of the l3th European Congress of Internal

Medicine of the European Federation of Internal Medicine (EFIM) and the 82nd

Annual Meeting of the Swiss Society of General Internal Medicine (SGIM), 14-16 May

2014 Geneva, Switzerland.

C2 Efectos sobre la sensibilización central de la terapia de regulación neuroadaptativa.

Tesis Doctoral Carlos Udina, Universidad Rey Juan Carlos, Madrid, 2017

C3 Tarakanov A., Ephremov V, Tarakanov A. Jr. Personalized transcutaneous

neurostimulation (SCENAR therapy) with control of radiothermometry and

stabilometrics for patients with lower back pain // Breakthrougs in Muscle Pain

Research & Practice. Extracts from the Tenth World Congress on Myofascial pain

syndrome and Fibromyalgia syndrome (MYOPAIN-2017), October 4-8, 2017,

Bengaluru, India.

4.4 Clinical data from literature

4.4.1 Search strategy

Objectives:

- population: adult patients with acute or chronic musculosceletal or joint pain;

- intervention: SCENAR therapy;

- control (for controlled studies): placebo, drug therapy for pain;

- clinical outcomes: pain reduction, reduction in drug therapy for pain if applicable, quality

of life if applicable;

- safety outcomes: serious or mild adverse events;

- study design: randomized controlled trials (RCT), controlled studies or prospective case

series with more than 100 patients involved and length of follow-up 1 month for efficacy

measurement; RCTs, controlled studies or prospective case-series with more than 10 patients, length

of follow-up at least 1 month or adverse effect reports to evaluate clinical safety of the Device.

Sources:

1. ScienceDirect

2. MEDLINE / PubMed

3. CLINICALTRIALS.GOV

4. Cochane Library

5. ResearchGate.net

6. EFIC 2015 abstracts (www.efic.org)

7. http://scenarenfrance.com/

Keywords:

SCENAR, SCENAR therapy, SCENAR pain.

Search dates:

Up to 01/02/2019

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Search plan:

We search all databases by specified keywords and pick up abstracts. We join search

results for all databases and get list of unique records. We exclude records with unavailable

abstracts or not referred to search goal. We analyse abstracts and exclude unrelevant and

duplicated records. For relevant records we search for fulltext publications. We also include

published conference papers and registered clinical trial results in analysis. We analyze fulltext

publications for eligibility and exclude publications at this stage by reasons: wrong study design,

wrong data analysis, lack of information on study details. Finally we include fulltext publications

in comprehensive clinical analysis.

Search results:

From 68 records identified we select 5 appropriate clinical studies to assess performance

and 9 studies to assess safety. Other 54 records were excluded with reasons.

Complete literature search report is specified in Annex 1.

4.4.2 Search summary

Search results are specified in Table 4 and Table 5.

Table 4

# Title, Author, Publication

A1 Jaesung Han, Inbo Han. A Comparative Study of the Efficacy between Self-controlled

Energo-Neuro-Adaptive Regulator and Transcutaneous Electrical Nerve Stimulation

for Whiplash Injury // The Nerve.2016.2(2):33-37

[RCT]

A2 R. Schukro, I. Mandl-Krusche, A. Kaider, S. Sator-Katzenschlager (Austria). Benefit in

patients with knee osteoarthritis through adjuvant electro auricular acupuncture vs.

Manual body stimulation with self-controlled energo neuro adaptive regulation

(SCENAR®™) // EFIC 2015 abstracts. Vienna, Austria, 2-5 September 2015

[RCT]

A3

Y. Eun, W. Choi the effect of SCENAR and TENS (transcutaneous electrical nerve

stimulation) on the pain relief in patients with chronic neck pain // EFIC 2015 abstracts.

Vienna, Austria, 2-5 September 2015

[RCT]

A4 In Bo Han, Ryoong Huh. SCENAR therapy for myofascial pain syndrome // Abstracts

of WACBE World Congress on Bioengineering 2007, Bangkok, THAILAND

[CR]

A5 In Bo Han, Ji Young Moon, Ryoong Huh, Hye Young Yoo, Sang Sup Chung. The

Efficacy of SCENAR Therapy for Myofascial Pain Syndrome

[CR]

Table 5


B1 J. N. Chernov, A.P. Balanovsky, S.V. Svirko, A.V. Chernov, I.S. Chernova, G.T.

Kairov. Advantages of scenar-therapy in treating chronic adnexitis// SCENAR-therapy

and SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles

B2 A.V. Tarakanov, E. V. Kutovaia. SCENAR Therapy of chronic insomnia and

neurocirculatory asthenia in emergency doctors // Nondrug medicine – 1/2007. St.

Pertersburg, Russia

B3 T.A. Shepeleva, A.E. Stolbov. SCENAR in treating chronic adnexitis // SCENAR-

therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles

B4 Ryoong Huh, In Bo Han. SCENAR therapy for lymphedema // Abstracts of WACBE

World Congress on Bioengineering 2007, Bangkok, THAILAND

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B5 L.V.Borovkova, I.E.Holmogorova, V.D.Uchaikina, E.V.Chelnokova. SCENAR-

therapy clinical effectiveness for the patients with tubal-peritoneal infertility

B6 N.N.Usalyova, L.V.Klimova, A.V.Tarakanov. SCENAR-Therapy Effects on Blood

Pressure and State of the Blood Plasma Oxidant-Antioxidant System in Patients with

Compression Injuries Complicated by Acute Renal Failure // Reflexology Journal,

Issue No: 3 (7), 2005, Moscow, Russia

B7 Borovkova L.V., Kholmogorova I. E., Umiarov R.V. The Effectivity Of The Electro-

Impulse Therapy With The Help Of SCENAR Device On Patients With External

Genital Endometriosis (EGE)

B8 Yurova Y.V., Tarakanov A.V. The effectiveness of SCENAR biofeedback

transcutaneous electroneurostimulator in treatment of burn patients // “Emergency

Medical Aid” – Russian research and practice journal, 2006, volume 7, No.3 – p. 138

B9 Los E.G., Tarakanov A.V., Hatisova E.V. Using SCENAR-therapy for treating

hypertension crisis in pre-hospital period // Reflexology – 2008 – No. 3-4 – pp. 23-26

4.5 Summary and appraisal of clinical data

Overall 10 fulltext papers and 4 published abstracts with results of clinical trials were

identified through literature search. Additionally, 3 clinical studies were identified through

PMCF procedure.

We use following designation of evidence grades in assessment of performance:

Ia – evidence from meta analysis of randomized controlled trials (RCT);

Ib – evidence from at least one RCT;

IIa – evidence from at least one non-randomized well-formed clinical trial (CT);

IIb – evidence from at least one well-formed quasi-experimental CT;

III – evidence from well-formed comparative studies or case series;

IV – evidence from expert reports and/or clinical experience.

We use following study classification codes:

1 – RCT ;

2 – Quasi-experimental (non-randomized) CT ;

3 – controlled observational study ;

3a – cohort study ;

3b – case series with controls ;

4 – prospective case series without controls;

5 – case reports.

We use following level of evidence codes:

A – high level (multiple RCTs);

B – moderate level (one RCT);

C – limited or contradictory evidence;

D – incomplete evidence;

We use following outcome effect codes:

P – positive result (significant clinical effect);

N – negative result (no significant clinical effect);

I – inconclusive (contradictory clinical effect in different studies);

A1) Jaesung Han, Inbo Han. A Comparative Study of the Efficacy between Self-controlled

Energo-Neuro-Adaptive Regulator and Transcutaneous Electrical Nerve Stimulation for

Whiplash Injury. The Nerve.2016.2(2):33-37.

In this randomized controlled prospective study 60 patients (aged 20-50 years old) with

post-traumatic neck pain were assigned to receive either transcutaneous electrical nerve

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stimulation (TENS) therapy (28 patients, control group) or SCENAR therapy with SCENAR

device (32 patients, experimental group).

The treatment regimen included 20-min treatment sessions for 4 weeks (3 times per week).

Therapeutic effects were evaluated at each of the assessment points (0, 4, 8, 12 and 16 weeks)

using a visual analogue scale (VAS) pain scores and neck disability index (NDI) scores.

The SCENAR group showed superior pain reduction compared with TENS (SCENAR:

initial mean VAS score; 6.3, final mean VAS score; 2.1, TENS: initial mean VAS score; 6.2,

final mean VAS score; 3.7). Sixteen week NDI scores showed the disability level of the

SCENAR group (9.5) was significantly lower than that of the TENS group (14.3).

SCENAR therapy provided a significant reduction in the intensity of neck pain (VAS) and

disability (NDI) compared with TENS group. SCENAR therapy is superior to the TENS therapy

in reducing and disability for whiplash injury.

No adverse affects were registered in any of intervention groups.

Evidence grade: Ib/1/B/P

A2) R. Schukro, I. Mandl-Krusche, A. Kaider, S. Sator-Katzenschlager (Austria). Benefit

in patients with knee osteoarthritis through adjuvant electro auricular acupuncture vs. Manual

body stimulation with self-controlled energo neuro adaptive regulation (SCENAR®™). EFIC

2015 abstracts. Vienna, Austria, 2-5 September 2015.

In this randomized controlled study patients with knee osteoarthritis were assigned to

electrical auricular acupuncture (EAA) group (15 patients), SCENAR group (14 patients) and the

control group (15 patients). Amount of rescue medication, pain intensity (NRS), range of motion

(ROM) in the sagittal plane and the pain free walking distance in minutes as well as knee

function assessment were evaluated on study day 1, 42 and 70.

Comparing the rescue medication after baseline therapy no significant difference was

found between the three groups (p=0,86). In the control group we found a median of 1 [Q1

25%=1; Q3 75%=2], in EAA group a median of 0 [Q1=0;Q3=3] and in the SCENAR group a

median of 0 [Q1=0;Q3=3]. Highly significant differences of amount of rescue medication were

found on day 42 and 70 comparing EAA group and control group (p<0,001), as well as in the

SCENAR group compared to the control group.

The results of this study show that EAA and SCENAR in combination with medical

analgesic treatment are superior to medical analgesic treatment alone. Pain relief was maintained

one month after the therapy was discontinued in these two complementary methods.

This is published abstract, no fulltext paper on this study was published at the day of this

report and no additional information available to perform more comprehensive analysis.


A3) Y. Eun, W. Choi the effect of SCENAR and TENS (transcutaneous electrical nerve

stimulation) on the pain relief in patients with chronic neck pain. EFIC 2015 abstracts. Vienna,

Austria, 2-5 September 2015.

In this study 24 elderly patients with chronic neck pain of more than 3 months duration

were randomized to receive SCENAR therapy (experimental group, 11 patients) or TENS group

(controls, 13 patients) three times a week for two weeks.

The patients were assessed before and after 2-week treatment using three measuring tools

such as Numeric Rating Scale (NRS), Neck Disability Index (NDI), and Range of Motion

(ROM).

The SCENAR group showed significantly improved results in NRS, NDI, and ROM after

intervention, as did the TENS group.(p<0.05) The comparison of mean changes in the SCENAR

group(12.36) before and after intervention showed superior results in the NDI when compared

with the TENS group(3.950).

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The findings show that both SCENAR and TENS are effective treatment for patients with

chronic neck pain. Patients who underwent SCENAR had a significant improvement in Neck

Disability Index (NDI) than the TENS group.



Evidence grade: Ib/1/D/P

A4) In Bo Han, Ryoong Huh. SCENAR therapy for myofascial pain syndrome. Abstracts

of WACBE World Congress on Bioengineering 2007, Bangkok, THAILAND.

In this study 202 patients (aged 18-65 years) with myofascial pain syndrome (MPS) were

treated by SCENAR therapy. The mean frequency of this treatment was 3 times a week and the

mean duration time per each treatment was 5 minutes. The mean follow up period was 6 months

(range: 3 months- 16months). The visual analogue scale (VAS) was used to assess the

effectiveness of SCENAR therapy.

The overall improvement of pain was 89%. Especially, the improvement of acute pain was

good, and all patients presenting MPS were satisfactory.



This study is a prospective case-series, not an RCT.

Evidence grade: III/4/D/P

A5) In Bo Han, Ji Young Moon, Ryoong Huh, Hye Young Yoo, Sang Sup Chung. The


In this study 340 patients (138 male, 202 female; ages 23-76 years; mean age 43.5 years)

with myofascial pain syndrome were included in this study. All patients were treated by

SCENAR therapy. During the period of SCENAR therapy, none of the patients underwent any

form of therapy excepted for the SCENAR therapy to check the effect of SCENAR therapy. The

study was approved by the institutional review board of the University of Pochon CHA,

Sungnam, Korea.

Therapeutic effects were evaluated before treatment, at 1 week, and at month after the end

of treatment using a visual analogue scale (VAS).

The patients treated by SCENAR showed a significant improvement of performance in

pain score (VAS) and in the evaluation of myofascial trigger point characteristics. A significant

increase in the ROM was also achieved. One week after the end of the SCENAR therapy, 296

patients (87.2 %) had experienced effective pain relief, and these improvements persisted at 1

month pos-treatment. The patients were classified into subgroups; low back pain subgroup and

neck pain group including shoulder pain. The reduction in the pain intensity was achieved in

83.1% among the low back pain subgroup (n=95) and in 88.7% among the neck pain subgroup

(n=245). The effect of SCENAR therapy in cases of neck pain was superior to that in cases of

low back pain. No serious complications occurred during the treatment.


C1) Tarakanov A.A., Efremov V. V., Nelassov N.J., Tarakanov V.A., Karkoshko T.A.,

Erofeeva A. V. Transdermal neurostimulation in dorsalgia patients at pre-hospital stage of

medical care. Abstracts of a joint venture of the l3th European Congress of Internal Medicine of

the European Federation of Internal Medicine (EFIM) and the 82nd Annual Meeting of the Swiss

Society of General Internal Medicine (SGIM), 14-16 May 2014 Geneva, Switzerland.

In this multicenter study patients with dorsalgias at pre-hospital stage of medical care

received either SCENAR therapy (101 patient in two experimental groups) or ketorolac

tromethamine 2 ml (30 mg) i. m. as pain management therapy (25 patients, Group 3) or

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ketoprofen 2 ml (100 mg) i. m. (54 patients, Group 4). Dynamics of clinical symptoms and

intensity of analgesia in 10 - 30 minutes after procedure or intake of pain killer were

analyzed.

Before treatment subjective estimate of pain according visual analogue scale in groups was

5-7 points. Lowering of pain level for 55-60% of initial intensity after treatment was noted in all

groups; a great regress of clinical symptoms was registered. SCENAR-therapy in 1st and 2nd

groups was comparable in efficacy with medicamental methods. Therefore SCENAR-therapy in

dorsalgia patients at pre-hospital stage of medical care was simple and effective method for pain

relief.



Evidence grade: IIa/2/D/P

C2) Efectos sobre la sensibilización central de la terapia de regulación neuroadaptativa.

Tesis Doctoral Carlos Udina, Universidad Rey Juan Carlos, Madrid, 2017.

In this randomized controlled double blind study, 37 adult women with diagnosis of

fibromyalgia were randomized to receive either SCENAR therapy (20 patients, experimental

group) or placebo (17 patients, control group). Patients in the experimental group were treated

with 35-min SCENAR sessions two times a week. Overall 12 variables concerning pain levels,

life quality and function were evaluated.

SCENAR was effective in management of central pain in fibromyalgia patients.


C3) Tarakanov A., Ephremov V, Tarakanov A. Jr. Personalized transcutaneous

neurostimulation (SCENAR therapy) with control of radiothermometry and stabilometrics for

patients with lower back pain // Breakthrougs in Muscle Pain Research & Practice. Extracts from

the Tenth World Congress on Myofascial pain syndrome and Fibromyalgia syndrome

(MYOPAIN-2017), October 4-8, 2017, Bengaluru, India.

In this randomized controlled study, 98 patients with non-specific low back pain were

randomized to receive either a conventional syndrome-oriented conservative treatment alone (33

patients, control group) or a conventional treatment with addition of SCENAR therapy (65

patients, experimental group). Treatment groups were comparable in patient age and pre-

treatment pain assessment scores. Each patient in the experimental group received up to 10

sessions of SCENAR treatment. Overall treatment period was 3 weeks.

The main interest was the application of the transcutaneous neurostimulation method as a

complementary treatment. Though the conventional treatment was efficient, the inclusion of the

SCENAR therapy demonstrated more significant efficacy comparing to the control group,:

patients from the experimental group experienced more significant reduction in pain assessment,

social status, and economic status scores. The greatest (up to 81 percent) reduction in scores was

reported according to pain intensity criterion. Transcutaneous neurostimulation method was

effective in complex treatment in patients with non-specific low back pain.

B1) J. N. Chernov, A.P. Balanovsky, S.V. Svirko, A.V. Chernov, I.S. Chernova, G.T.

Kairov. Advantages of scenar-therapy in treating chronic adnexitis // SCENAR-therapy and

SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles.

In this study 60 women with chronic adnexitis were treated with SCENAR as

monotherapy (30 patients in experimental group) or with standard medical treatment (30

patients, control group). Average duration of staying in the hospital after medical treatment was

10 days, after monotherapy with SCENAR – about 3 days. All treatment course was 17-30 days

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long. No allergic reactions or other complications were observed in SCENAR group. In control

group 6 patients had developed some reactions on drugs used.

Evidence grade: IIb/2/D/P

B2) A.V. Tarakanov, E. V. Kutovaia. SCENAR Therapy of chronic insomnia and

neurocirculatory asthenia in emergency doctors // Nondrug medicine – 1/2007. St. Pertersburg,

Russia.

In this randomized controlled study, 73 patients with chronic insomnia were treated either

with SCENAR (20 patients, experimental group) or with Zopiclone soporific medicine (53

patients, control group). Treatment course was 10 days long.

Use of soporific medicine and SCENAR-therapy for treatment of chronic insomnia reliably

improved almost all the subjective characteristics of sleep (excluding its duration). The

comparative analysis of the results showed that SCENAR-therapy influences mostly intra- and

postsomnic disorders. Zopiklon and SCENAR-therapy have similar positive therapeutic effect on

insomnia. During the research none of the patients cancelled the treatment or treatment was not

cancelled due to side effects. The effect of SCENAR-therapy lasts for 1-4 months.


B3) T.A. Shepeleva, A.E. Stolbov. SCENAR in treating chronic adnexitis. SCENAR-

therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles.

In this study 30 women with chronic adnexitis were treated either with medications

(indomethacin, ortophen, diclofenac, magnesium sulfate, reopyrinym, donalgin, lydazum,

immunomodulators, desensitizing and sedative medications) combined with physiotherapy –

quartz, electrophoresis, UHF currents, and ultrasound (10 patients, control group), or with

SCENAR therapy alone (10 patients) or with SCENAR-therapy and homeopathic medications

(10 patients).

By the end of the treatment course (3-4 weeks) only 3 women from the first group had

been reported to have no pain syndrome, pain had considerably decreased by 4 women, in 4% of

cases premenstrual and ovulatory syndromes had been reduced. 6 patients still didn’t have a

normal two-phase menstrual cycle during the first three months after the treatment. 4 patients

had to repeat courses of treatment and then undergo resort treatment.

In the second group pain syndrome decreased considerably after 2-3 treatments, after 4-5

treatments there was a short-term appearance or a slight intensification of pains, after the 6th

treatment pain completely disappeared.

Menstrual cycle was restored by all the patients. During a year afterwards there were no

ovulatory or premenstrual syndromes. During the first 3 months a two-phase menstrual cycle

was restored by eight women, two patients needed an additional treatment course in 3 months for

a two-phase cycle’s restoration.

In the one-year follow-up 2 women from the second group and 3 women from the third

group became pregnant whereas There were no cases of pregnancy among the patient from the

control group.


B4) Ryoong Huh, In Bo Han. SCENAR therapy for lymphedema // Abstracts of WACBE

World Congress on Bioengineering 2007, Bangkok, THAILAND.

In this study SCENAR therapy was performed in 28 patients with lymphedema caused by

radiation treatment of cancer.

All patients were female and were performed radiation treatment due to breast cancer in-7

patients, cervical cancer in 13 patients, and ovarian cancer in 8 patients. The mean age was 53.7

years (range: 37-65 years). The mean frequency of SCENAR therapy was 4 times a week and the

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mean duration time per each treatment -was 8 minutes. The mean follow up period was 7 months

(range: 3 months-18months). The circumference of affected extremities was measured before

and after treatment. The overall improvement of lymphadema was 79% and the pain associated

with lymphadema also improved in 85 % of patients. This study suggested that the SCENAR

device impulse helps fluid come out of the lymphatic system and improves the microcirculation.

SCENAR device also eliminates inflammatory process in the lymph nodes. Therefore, -

SCENAR therapy would be very useful method to deal with lymphedema.


B5) L.V.Borovkova, I.E.Holmogorova, V.D.Uchaikina, E.V.Chelnokova. SCENAR-

therapy clinical effectiveness for the patients with tubal-peritoneal infertility.

In this study 111 patients with tubal-peritoneal infertility were observed and treated with

laparoscopy (30 patients, controls), laparoscopy and SCENAR (39 patients) and SCENAR alone

(42 patients). Overall 81 patients were in experimental groups.

Autonomic status in the second and the third groups normalized after SCENAR-therapy.

The indices in the first group didn’t change.

The psychological state was analyzed before and after the treatment in all patients. There

was marked improvement of all components of the psychological well-being index (anxiety,

depression, self-control, health in general, emotional security, vital power). There was a 16%

increase in the first group, 48% - in the second and 43% in the third one.

The dynamics of indices that influence the patients’ lives considerably (paramenia,

dyspareunia, pains in the intermenstrual period, defecation disorders) were also analyzed. The

positive dynamics was more considerable in the groups where SCENAR-therapy was used as

compared with the control group. Results of SCENAR-therapy both after laparoscopy

operations, and without it, allow us to exclude laparoscopy as a method of fallopian tubes

correction, provided that there was an absence of hydrosalpinxes and that infertility period did

not exceed 3 years. Patients from the second group (51%) and from the third group (45%)

achieved the best results in the restoration of uterine tubes clearance and the ability to conceive.


B6) N.N.Usalyova, L.V.Klimova, A.V.Tarakanov. SCENAR-Therapy Effects on Blood


Compression Injuries Complicated by Acute Renal Failure // Reflexology Journal, Issue No: 3

(7), 2005, Moscow, Russia.

In this study, 112 patients with acute renal failure caused by compression injury were

observed and treated with standard intensive therapy, from which 46 patients received standard

therapy alone (control group), 41 patients received Isradipine 2.5 mg twice daily in complex

treatment (group 1) and 25 patients received isradipine and SCENAR therapy.

Blood pressure characteristics were registered on admission, on the 1-2 day of diuresis

recovery and on transfer to the relevant department. The blood samples for biochemical tests

were taken on admission and on the 1-2 day of diuresis recovery.

SCENAR-therapy in combination with Isradipine (2.5 mg twice daily) administered

sublingually was considered the most effective method for adjusting blood pressure in patients

with acute renal failure following the compression injury.


B7) Borovkova L.V., Kholmogorova I. E., Umiarov R.V. The Effectivity Of The Electro-

Impulse Therapy With The Help Of SCENAR Device On Patients With External Genital

Endometriosis (EGE).

In this study 241 women with external genital endometriosis (EGE) were observed and

treated. According to the Classification of the American society on fertility 60 (24.8%) of the

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patients were with 1st degree of severity of ЕGE, 50 (20.7%) - with 2nd degree, 111 (46%) -

with 3rd degree and 20 (8.5%) - with 4th degree.

A laparoscopy was made to all patients on the first stage of the treatment according to the

spread of EGE: a coagulation of EGE sites, resection of the endometrial cists of the adnexa with

a coagulation of the bed, incision of the adhesions. On the second stage of the treatment the

patients with EGE were divided into two groups.

In the first group – 141 patients took hormonomodulizing preparations for 6 months. In the

second group 100 patients were treated by SCENAR therapy (1 to 3 courses with 1-month

interval).

The recurrence rate of the disease after the hormonomodulizing therapy in a period from 6

months to 1.5 years was 38.2% (22.8%, 33.3%, 37.7% and 60% at І, ІІ, ІІІ, and ІV degrees of

severity respectively). Only 25.5% of the patients with EGE become pregnant 6 months to 1 year

after the hormonomodulizing therapy.

No recurrence of the disease was detected up to 1.5 years in the patients with EGE, treated

with SCENAR in the postoperative period. 68% of the patients become pregnant (82%, 79%,

35% and 22% at І, ІІ, ІІІ, and ІV degrees of severity respectively).


B8) Yurova Y.V., Tarakanov A.V. The effectiveness of SCENAR biofeedback

transcutaneous electroneurostimulator in treatment of burn patients // “Emergency Medical Aid”

– Russian research and practice journal, 2006, volume 7, No.3 – p. 138.

In this study 40 patients with burns were observed and treated. In the control group 23

patients received non-narcotic analgesics only as analgesic treatment. In the experimental group

17 patients received a combination of non-narcotic analgesics and SCENAR therapy.

The results showed that painful sensation was reduced in 94% of the primary group (16

patients). In the control group, where non-narcotic analgesics only were used as analgesic

therapy, a sufficient analgesic effect was noted only in 56% of the patients (13 patients). 44% of

the patients (10 people) asked for additional analgesic injections due to pain complaints.

Idiosyncrasy to eradiated electric current when treated with SCENAR was found in 1 patient

(unpleasant sensations in the affected area). One patient refused to be injected – SCENAR

treatment was sufficient to eliminate painful sensations in wounds.


B9) Los E.G., Tarakanov A.V., Hatisova E.V. Using SCENAR-therapy for treating

hypertension crisis in pre-hospital period // Reflexology – 2008 – No. 3-4 – pp. 23-26.

In this study 97 patients with uncomplicated hypertensive crises in pre-hospital period

were treated by SCENAR. The patients were selected using the technique of random sampling.

Patients’ average age was 60.2±1.3, among them 71 women (73%) and 26 men (27%).

Immediately after the SCENAR-manipulation a significant arterial pressure decreasing was

achieved, a decrease in frequency of complaints form headaches, heartaches, head noises,

photopsia, nausea, vomiting and dizziness was stated. Frequency of cases of facial hyperemia

also dropped in 10 minutes. The frequency of heartaches, photopsia, nausea, and vomiting

decreased to the greatest degree in 20 minutes after the manipulation.

SCENAR-therapy was considered as an effective and safe therapeutic method for cases of

uncomplicated hypertensive crises in pre-hospital period.


R1) Medical Device Clinical Trial Evaluation Report as of November 27, 2014. SCENAR-

NT Transdermal Electrostimulators in six versions with accessories (Appendix 3) by TR 9444-

015-05010925-2004 Manufactured by: RITM OKB ZAO, Russian Federation (Акт оценки

результатов клинических испытаний медицинского изделия от «27» ноября 2014 г.

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«Электронейростимуляторы чрескожные «СКЭНАР-НТ» в шести исполнениях с

принадлежностями (Приложение 3) по ТУ 9444-015-05010925-2004» производства: ЗАО

«ОКБ «РИТМ», Россия).

This clinical evaluation report has been conducted under local regulations and international

standard ISO 14155:2011 "Clinical investigation of medical devices for human subjects - Good

clinical practice" in form of literature analysis.

Overall 28 clinical studies were identified in this clinical evaluation report that can be

summarized by clinical indications.

1) patients with pain at pre-hospital stage: 5 studies from which 20 patients with traumas,

26 patients with angina pectoris and 153 patients with arterial hypertension, 100 patients with

chronic neck pain, 259 patients with chronic low back pain, 108 patients with unspecific chronic

back pain. Results showed that SCENAR therapy was considered as an effective and safe

therapeutic method for pain relieving at pre-hospital stage.

2) patients with jaw fractures: 1 study with 306 patients involved. SCENAR was

considered as an effective and safe method for pain relieving and supplemental therapy in

patients with jaw fractures in terms of pain levels and life quality indices.

3) patients with menstrual cycle disorders: 2 studies with 126 patients. SCENAR was

considered as effective and safe method for menstrual cycle normalization and demonstrated

long-term positive effects with 2-year follow-up.

4) patients with tubal-peritoneal infertility: 3 studies with 225 patients involved. SCENAR

was considered as effective and safe method for supplemental therapy in post-operative period

after laparoscopic operations in patients with tubal-peritoneal infertility.

5) patients with miscarriage of infectious genesis: 2 studies with 100 patients involved.

SCENAR was considered as effective and safe method for supplemental therapy in patients with

miscarriage of infectious genesis.

6) patients with polycystic ovarian syndrome: 1 study with 364 patients involved.

SCENAR was considered as effective and safe method of correction in patients with polycystic

ovarian syndrome.

7) patients with endometriosis: 2 studies with 336 patients involved. SCENAR was

considered as effective and safe method of supplemental therapy in patients with endometriosis.

8) patients with peritonitis in postoperative period: 1 study with 99 patients involved.

SCENAR was considered as effective and safe method of supplemental therapy in patients with

peritonitis in postoperative period.

9) patients with duodenal ulcer: 2 studies with 109 patients involved. SCENAR was

considered as effective and safe method when used in complex treatment of duodenal ulcer.

10) patients with ischemic heart disease: 1 study with 123 patients involved. SCENAR was

considered as effective and safe method when used in complex treatment in patients with

ischemic heart disease.

11) patients with ischemic insult in early period: 1 study with 50 patients involved.

SCENAR was considered as effective and safe method when used in complex treatment in

patients with ischemic insult in early period.

12) patients with arterial hypertensia and associated chronic insomnia in hospital: 1 study

with 150 patients involved. SCENAR was considered as effective and safe method when used in

complex treatment in patients with arterial hypertensia and associated chronic insomnia.

13) patients with myopia: 1 study with 45 patients (all children) involved. SCENAR was

considered as effective and safe method when used in complex treatment in patients with

myopia.

14) patients with opiate addiction: 1 study with 120 patients included. SCENAR was

considered as effective and safe method when used in complex treatment in patients with opiate

addiction.

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15) patients with asthma. 1 study with 48 patients (all children) involved from which 26

patients received SCENAR therapy. SCENAR was considered as effective and safe method

when used in complex treatment in patients with asthma.

16) patients with acute renal failure caused by compression injury (see B6). Overall 112

patients were treated in one study on acute renal failure caused by compression injury from

which 81 patients received SCENAR therapy in complex treatment. SCENAR-therapy as an

adjunct to complex treatment was effective for adjusting blood pressure in patients with acute

renal failure following the compression injury.

In conclusion, SCENAR-NT device was considered as effective and safe device. No

adverse reactions were detected when using this device.

4.6 Analysis of the clinical data

4.6.1 Requirement on safety

The Device does not contain any medicinal, human or animal components that pose special

safety concerns.

The safety characteristics and intended purpose of the device does not require training of

the end-user. The IFU contains all necessary information on the proper use of the Device.

4.6.1.1 Recognized Risks

Risk analysis conforms to ISO 14971, the results are described in SCENAR A6.14 Risk

Analysis of 19-07-2019.

4.6.1.2 Risks from improper clinical use

If using SCENAR devices the principal risk is a human factor, and a potential use of the

device in clinical conditions unspecified by the IFU, in particular, as well as its compatibility

with other treatment modalities.

Publications on using the Device in clinical conditions unspecified by the IFU were

classified according to the following applications.

Chronic adnexitis [B1, B3]

Overall 90 patients were treated in two studies on chronic adnexitis pain from which 50

patients received SCENAR device therapy.

Significant pain premenstrual syndromes reduction was observed in SCENAR groups at

the 3 month follow-up. Total follow-up was 1 year. No allergic reactions or other complications

were observed in SCENAR group compared to controls [B1].


Chronic insomnia [B2]

Overall 73 patients were treated in one study on chronic insomnia from which 20 patients

received SCENAR therapy.

SCENAR-therapy was as effective as soporific medicine in patients with chronic insomnia.

No side effects or therapy rejection was observed during treatment. The effect of SCENAR-

therapy lasts for 1-4 months.


Lymphedema caused by radiation treatment [B4]

Overall 28 patients were treated in one study on lymphedema caused by radiation

treatment. All patients received SCENAR therapy.

Significant pain and lymphedema reduction was observed in 3-18 month follow-up.


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Tubal-peritoneal infertility [B5]

Overall 111 patients were treated in one study on tubal-peritoneal infertility from which 81

patients received SCENAR therapy either as standalone treatment option or in complex

treatment.

Significant improvements in quality of life, pain reduction and treatment quality indices

were observed. SCENAR therapy was effective in complex treatment and as standalone option.


Acute renal failure caused by compression injury [B6]

Overall 112 patients were treated in one study on acute renal failure caused by

compression injury from which 81 patients received SCENAR therapy in complex treatment.

SCENAR-therapy as an adjunct to complex treatment was effective for adjusting blood

pressure in patients with acute renal failure following the compression injury.


External genital endometriosis [B7]

Overall 241 patients were trreated in one study on external genital endometriosis from

which 100 patients received SCENAR therapy in complex treatment.

SCENAR therapy was effective in prevention of recurrence of the disease in the 1.5-year

follow-up.


Pain management in burn patients [B8]

Overall 40 patients were treated in one study on burns, from which 17 patients received

SCENAR therapy in complex pain management.

SCENAR therapy as an adjunct to non-narcotic pain medication was an effective pain

management option in patients with burns.

There was one minor side effect (intolerance due to unpleasant sensations in the affected

area) observed in one patient that was inessential.


Uncomplicated hypertensive crises [B9]

Overall 97 patients were treated by SCENAR therapy in one study on uncomplicated

hypertensive crises at pre-hospital stage.




There was only one minor side effect observed in these studies on using SCENAR in

clinical conditions unspecified by IFU that was inessential.

As long as no such indications are specified in the IFU this kind of therapy can’t be

recommended in absence of good clinical evidence yet. Clinical investigations should be

conducted to assess clinical performance and safety of the Device in these clinical conditions.

Until that the results found should be considered preliminary.

4.6.1.3 Risks from specified engineering solution

The identified risks inherent in the use of SCENAR devices and measures to mitigate the

risks are listed in the table below.

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Table 6

Hazard type Harm Possible cause Risk reduction factors

Electricity Patient fright Sudden contact of

electrode with

patient skin having

impulse amplitude

maxed out

According to the safety standards,

amplitude value is minimal when turning

on the device.

The Operating Manual has a warning to

ensure that the amplitude value is set to

minimum when moving to another

treatment zone.

Toxicity Irritant effect

to patient skin

Usage of materials

with toxicity rates

that do not meet the

requirements for

medical products,

contacting with skin

Company policy is dealing with approved

suppliers only and using certified

components and materials.

Products passed toxicity tests and are

GOST R certified.

4.6.1.4 Risks from Device design

There are no risks identified in respect to the device design.

4.6.2 Requirement on acceptable benefit/risk profile

Overall 1777 patients were involved in the identified studies from which 1203 patients

(67,7%) received SCENAR treatment at least once. Only one minor side effect associated with

the Device was observed (p=0,00083). No side effects was observed when using the Device

according to the IFU.

4.6.2.1 Benefit rate

This clinical data analysis identified following clinical effects of use of the Device:

- short-time pain reducing effect comparable to pain medication in cases of acute low back

pain at pre-hospital stage [C1];

- significant pain reducing and improvement of functional indices in cases of chronic pain

[A3, A4, A5,C3];

- significant pain management of central pain in cases of fibromyalgia [C2];

- significant pain reducing and improvement of functional indices in cases of post-

traumatic pain [A1]

- significant decreasing of the medication usage in cases of knee osteoarthritis [A2].

No complications or adverse effects reported in identified studies.

No contraindications are found but one should avoid prescribing SCENAR- therapy in the

following cases:

- overly sensitive individuals;

- patients with cardiac pacemakers;

- alcohol intoxicated individuals;

- patients with acute infection diseases with obscure diagnosis.

Identification of possible risk and their comparison with long-term clinical practice in the

above conditions indicate the device benefit.

4.6.2.2 Benefit and Residual Risk Comparison

Considering the safety and noninvasiveness of the treatment modality declared by the

manufacturer, and based on clinical data, it is concluded that the device benefit is much higher

than the residual risk of its use (SCENAR A6.14 Risk Analysis of 19-07-2019).

The evaluation team analyzed all risk reduction activities and concluded that there are no

other possible hazard sources.

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After identification of possible risk and taking risk-reduction measures, SCENAR devices

risk acceptability is Level II – acceptable. Side effects which were found have been evaluated

as negligible and benefits for patient far prevail hazards.

4.6.3 Requirement on performance

Considering the indications provided in the IFU, all publications were classified according

to the following applications.

Acute pain

Acute low back pain [C1]

Overall 180 patients were treated in study on acute low back pain at pre-hospital stage,

from which 101 patients were treated by SCENAR therapy.

SCENAR therapy as pain management option was as effective as pain medication in

patients with acute low back pain at pre-hospital stage.

Only short-time follow-up (30 min) was assessed because of the aim of the study.

Evidence grade: IIa/2/D/P

Chronic pain

Chronic neck pain [A3]

Overall 24 patients were treated in study on chronic neck pain from which 11 patients

received SCENAR device therapy.

Significant improvements in the level of pain (NRS), range of motion (ROM) and neck

disability index (NDI) were observed in both groups but SCENAR demonstrates superior results

in NDI compared to controls at the 14 days follow-up.


Non-specific chronic low back pain [C3]

Overall 98 patients were treated in study on non-specific chronic low back pain from

which 65 patients received SCENAR device therapy in complex treatment.

Significant improvements in the pain assessment scores, functional assessment scores and

economic status assessment scores observed in both groups but addition of SCENAR demonstrates

superior results in complex treatment compared to controls at the 21 days follow-up.


Myofascial trigger points (myofascial pain) [A4, A5]

Overall 542 patients were treated in two studies on myofascial pain. SCENAR device was

used in both studies as monotherapy.

There was significant clinical effect observed in pain intensity (VAS) and range of motion

(ROM) measurements at the 30-day follow-up. No serious complications occurred during the

treatment.


Fibromyalgia [C2]

Overall 37 patients were treated in this study from which 20 patients received SCENAR

therapy. SCENAR was effective in management of central pain in fibromyalgia patients as

compared to placebo treatment.


SCENAR 813.14Pain in joints or ligaments

Osteoarthritis of the knee ll2].. overall 46 patients were included in two studies on knee osteoarthritis from which 14patients received SCENAR device trearrnent.

Significant improvement in the medication usage were observed in this study study in 70day follow-up.Evidence grade: Ib/ | lBlp

Post-traumatic pain

P o st-traumatic pain (ne ck pain) [Al]- Overall 60 patients were included in post-traumatic neck pain study. SCENAR device wasused in experimental group.

Significant improvements in the intensity of neck pain (VAS) and disability (NDI) wereobserved in the trealmTt group compared to controls in ttre l'6-week follow-up.Evidence grade: Ibl I lBlp

4.6.4 Requirement on acceptability of side-effectsAmount of data present is sufficient to detect undesirable side effects. None of the detectedside effects are considered significant. No serious adverse events was detected.

5 Conclusions

The Device is compliant to the MDD Essential requirements. The Device risk acceptabilityis Level rI - acceptable. Side effects which were founi have been evaluated as.negligible andbenefits for patient far prevail hazards.The information materials presented by manufacturer are adequate and sufficient for end-user to work with the Device properly and to mitigate possible risks.The Device (including the IFU) is suitable to all user categories specified by theManufacturer in the IFU.The clinical data, the risk management documents and the information materials specifiedby the manufacturer are consisteni. There are no unsupported claims foreseen by theManufacturer.No additional PMS activities are required to support of the Manufacturer,s claims at thetime of this report.

6 Date of the next clinical evaluation

01th February 2020

7 Dates and signatures

M.D., Professor A.Tarakanov

Candidate of Engineering Science A. Cherchago

Candidate of Engineering Science A. Molchanov

<</9> 0 Y zotglssue 14 of l9-07-20t9 Page22 of 5l

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8 Qualification of the responsible evaluators

Тarakanov Alexandr Viktorovich, M.D., Post-Doctoral Degree in Medicine, 11 years

of experience in the enterprise in the collection and analysis of clinical data on the effectiveness

and safety of medical devices (see Annex 2).

Cherchago Alexandr Yakovlevich, Candidate of Engineering Science, 4 years of

experience in the collection and analysis of clinical data on the effectiveness and safety of

medical devices (see Annex 3).

Molchanov Artyom Yuryevich, Candidate of Engineering Science, 4 years of

experience in the collection and analysis of clinical data on the effectiveness and safety of

medical devices (see Annex 4).

9 References

1. Stillings D.

A Survey Of The History Of Electrical Stimulation For Pain To 1900.

Med.Instrum 9: 255-259 1975.

2. Johnson M.

Transcutaneous electrical nerve stimulation (TENS).

http://187.45.210.15/$sitepreview/tanyx.net/Img/Propaganda/TENS%20Explained%20Chapter.pdf

3. Johnson M., Martinson M.

Efficacy of electrical nerve stimulation for chronic musculoskeletal pain: a meta-analysis of

randomized controlled trials.

Pain. 2007 Jul;130(1-2):157-65 PMID: 17383095

4. Pantaleao M.A., Laurino M.F., Gallego N.L. et al. (2011) Adjusting pulse amplitude during

transcutaneous electrical nerve stimulation (TENS) application produces greater hypoalgesia.

Journal of Pain, 12: 581–590.

5. Авторское свидетельство A 1 1817335 SU 6 A 61 N 1/36. Электростимулятор / Захаревич

В.Г., Нечушкин А.И., Карасев А.А., Ревенко А.Н., Кибирев А.А. (Таганрогский

радиотехнический институт им.В.Д.Калмыкова). - № 4171898/14; Заявл. 04.01.1987.

Author's certificate A 1 1817335 SU 6 A 61 N 1/36. Electrostimulator / V. G. Zakharevich, A.I.

Nechushkin, A.A. Karasev, A.N. Revenko, A.A. Kibirev (V. D. Kalmykov Taganrog Radio

Engineering Institute) - No. 4171898/14; claim 04.01.1987.

6. Патент C 1 2091089 RU 5 A 61 N 1/36. Устройство для электростимуляции / Карасев

А.А., Захаревич В.Г., Ревенко А.Н., Кибирев А.А., Дыгай А.И. (Товарищество с

ограниченной ответственностью «ОКБ РИТМ»). – № 4654349/14; Заявл. 06.03.1989.

Patent C 1 2091089 RU 5 A 61 N 1/36. Device for electrostimulation / A.A. Karasev, V. G.

Zakharevich, A.N. Revenko, A.A. Kibirev, A.I. Dygai (‘RITM OKB’ LLP) - No. 4654349/14;

claim 06.03.1989.

7. Патент C 1 2135226 RU 5 A 61 N 1/36. Электростимулятор нейроадаптивный / Гринберг

Я.З., Зенкин М.В., Ревенко А.Н. (Закрытое акционерное общество «Особое

конструкторское бюро «Ритм»). – № 97102802/14; Заявл. 25.02.1997.

Patent C 1 2135226 RU 5 A 61 N 1/36. Neuroadaptive electrostimulator / Y.Z. Grinberg, M. V.

Zenkin, A.N. Revenko (‘RITM OKB’ ZAO) - No. 97102802/14; claim 25.02.1997.

http://dspace.ceu.es/bitstream/10637/2319/1/Stillings_D.pdf

http://187.45.210.15/$sitepreview/tanyx.net/Img/Propaganda/TENS%20Explained%20Chapter.pdf

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8. Акт о проведении клинических испытаний электростимулятора нейроадаптивного

СКЭНАР-НД, выдан Московским государственным медико-стоматологическим

университетом (МГМСУ), 2001.

Clinical trials report for SCENAR-ND neuroadaptive electrostimulator, issued by Moscow State

Medical and Stomatological University, 2001.

9. Отчет о проведенной научно-исследовательской работе по испытанию образца

электростимулятора для воздействия на рефлекторные зоны «СКЭНАР-НД», выдан

Московской медицинской академией им. И.М.Сеченова, 2001.

Report on a research effort carried out for SCENAR-ND electrostimulator for stimulation of

reflex zones, issued by the I.Sechenov Moscow Medical Academy, 2001.

10. Протокол медицинских испытаний электростимулятора чрескожного с биообратной

связью индивидуально дозированного воздействия на рефлекторные зоны ЧЭНС-

«Скэнар», выдан Федеральным научным клинико-экспериментальным центром

традиционных методов диагностики и лечения МЗ РФ (ФНКЭЦ ТМДЛ МЗ РФ), 2003.

Medical trials report for CHANS-SCENAR biofeedback transdermal electrostimulator with

individual dosing of reflex zone stimulation, issued by the Federal Scientific Clinical and

Experimental Center of Traditional Diagnostic and Treatment Methods, Ministry of Public Health

of the Russian Federation, 2003.

11. Акт о проведении клинических испытаний электростимуляторов чрескожных с

биообратной связью индивидуального дозирования воздействия на рефлекторные зоны

ЧЭНС-«СКЭНАР» (исполнение 01 и 02), выдан Московским государственным медико-

стоматологическим университетом (МГМСУ), 2003.

Clinical trials report for CHANS-SCENAR (version 01, version 02) biofeedback transdermal

electrostimulators with individual dosing of reflex zone stimulation, issued by Moscow State

Medical and Stomatological University, 2003.

12. Протокол медицинских испытаний электростимулятора для воздействия на

рефлекторные зоны ЧЭНС-«СКЭНАР», выдан Российской медицинской академией

последипломного образования (РМАПО), 2003.

Medical trials report for CHANS-SCENAR electrostimulator for reflex zone stimulation, issued

by Russian Medical Academy of Post-Graduate Education, 2003.

13. Акт о проведении клинических испытаний электростимуляторов нейроадаптивных

СКЭНАР-2003 (исполнение 01, 02, 03, 04, 05), выдан Московским государственным

медико-стоматологическим университетом (МГМСУ), 2004.

Clinical trials report for the SCENAR-2003 (versions 01, 02, 03, 04, 05) neuroadaptive

electrostimulators, issued by Moscow State Medical and Stomatological University, 2004.

14. Протокол медицинских испытаний электростимуляторов нейроадаптивных для

неинвазивной биоуправляемой электроимпульсной терапии «СКЭНАР-2003» (исполнение

01, 02, 03, 04, 05), выдан Российской медицинской академией последипломного

образования (РМАПО), 2004.

Medical trials report for the SCENAR-2003 (versions 01, 02, 03, 04, 05) neuroadaptive

electrostimulators for non-invasive biocontrolled electropulse therapy, issued by Russian

Medical Academy of Post-Graduate Education, 2004.

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15. Протокол медицинских испытаний электростимулятора СКЭНАР-2003, выдан

Федеральным научным клинико-экспериментальным центром традиционных методов

диагностики и лечения МЗ РФ (ФНКЭЦ ТМДЛ МЗ РФ), 2004.

Medical trials report for the SCENAR-2003 electrostimulator, issued by the Federal Scientific

Clinical and Experimental Center of Traditional Diagnostic and Treatment Methods, 2004.

16. Протокол о проведении медицинских испытаний изделия медицинского назначения:

«Электростимуляторы нейроадаптивные СКЭЛАП», выдан Санкт-Петербургской

клинической больницей Российской академии наук, 2013.

Medical trials report for the SCELAP neuroadaptive electrostimulators, issued by Saint

Petersburg Clinical Hospital of the Russian Academy of Sciences (RAS), 2013.

17. Протокол о проведении медицинских испытаний изделия медицинского назначения:

«Электростимуляторы нейроадаптивные СКЭЛАП-НТ», выдан Санкт-Петербургской

клинической больницей Российской академии наук, 2013.

Medical trials report for the SCELAP-NT neuroadaptive electrostimulators, issued by Saint

Petersburg Clinical Hospital of the Russian Academy of Sciences (RAS), 2013.

18. Протокол медицинских испытаний электростимулятора для воздействия на

рефлекторные зоны «СКЭНАР-НД», выдан Научно-производственным центром

традиционной медицины и гомеопатии МЗ РФ (НПЦ ТМГ МЗ РФ), 2001.

Medical trials report for SCENAR-ND electrostimulator for stimulation of reflex zones, issued by

the Research-and-Production Center of Traditional Medicine and Homeopathy, Ministry of

Public Health of the Russian Federation, 2001.

SCENAR B13.14

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Annex 1

Literature search report

1. Literature search background

1.1 Device name and model

The proprietary name of the device is: SCENAR device (further the Device).

SCENAR device names and models are listed in the Table 1.

Table 1


CHANS-SCENAR CHANS-SCENAR RITMSCENAR Home

SCENAR Home

CHANS-01-SCENAR RITMSCENAR Sport

SCENAR Sport

SCENAR Pain Genie

RITMSCENAR Home Device

RITMSCENAR Gorfinkel

SCENAR Gorfinkel

CHANS-02-SCENAR RITMSCENAR Basic

SCENAR Basic

CHANS-SCENAR-M RITMSCENAR Home D

SCENAR Home D

CHANS-01-SCENAR-M RITMSCENAR Sport D

SCENAR Sport D

CHANS-02-SCENAR-M RITMSCENAR Basic D

SCENAR Basic D

SCENAR-NT SCENAR-1-NT (version 01) RITMSCENAR Pro Prime

SCENAR Pro Prime

SCENAR-1-NT (version 02.1) RITMSCENAR Pro Plus

RITMSCENAR Pro +

SCENAR Pro Plus

SCENAR Pro +

SCENAR-1-NT (version 02.2) RITMSCENAR Pro Optima

SCENAR Pro Optima

SCENAR-1-NT (version 02.3) RITMSCENAR Pro

SCENAR Pro

SCENAR-1-NT (version 03) RITMSCENAR Pro Essential

SCENAR Pro Essential

SCENAR-1-NT (version 01C) RITMSCENAR Pro Prime C

SCENAR Pro Prime C

RITMSCENAR Super Pro v.2

bioSCENAR Professional v.2

SCENAR-1-NT (version 02.1C) RITMSCENAR Pro Plus C

RITMSCENAR Pro + C

SCENAR Pro Plus C

SCENAR Pro + C

SCENAR-1-NT (version 02.2C) RITMSCENAR Pro Optima C

SCENAR Pro Optima C

SCENAR Physio

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SCENAR-1-NT (version 02.3C) RITMSCENAR Pro C

SCENAR Pro C

SCENAR-1-NT (version 03C) RITMSCENAR Pro Essential C SCENAR Pro Essential C

RITMSCENAR Expert

RITMSCENAR Expert C Add-on electrodes Face electrode

Comb electrode

Point electrode

Local electrode

Special Snail electrode

Bent point electrode

Double facial Pawns electrode

Double cosmetic electrode

Double ophthalmic Goggles electrode

Double facial Stamps electrode

Single ophthalmic Monocle electrode

Special double Pencils electrode

Large Comb electrode

Multi-purpose zonal electrode

These device models are equivalent in clinical performance and risks associated with

clinical use when using according to the IFU.

1.2 Importance to risk management process

Serious adverse event is defined as an adverse event that

a) led to death,

b) led to serious deterioration in the health of the subject, that either resulted in

1) a life-threatening illness or injury, or

2) a permanent impairment of a body structure or a body function, or

3) in-patient or prolonged hospitalization, or

4) medical or surgical intervention to prevent life-threatening illness or injury

impairment to a body structure or a body function,

c) led to foetal distress, foetal death or a congenital abnormality or birth defect.

Any adverse event that is not classified as serious is considered as acceptable.

This report covers clinical literature on clinical performance and risks associated with the

Device.

Clinical performance is assessed only when the Device is used according to the IFU.

Otherwise the use of the Device is considered as unsafe and associated risk is analyzed.











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2 Objective

PICO elements for literature search strategy are defined in Table 2.

Table 2

Population Adult patients with acute or chronic musculosceletal or joint pain

Intervention Scenar Therapy

Control Placebo, drug therapy for pain

Outcomes

Efficacy Pain reduction

Reduction in drug therapy for pain

Quality of life

Safety Serious adverse events

Mild adverse events

Study design

Efficacy Randomised controlled trials

Controlled studies or prospective case-series with more than 100 patients, length

of follow-up 1 month and more

Safety Randomised controlled trials

Controlled studies or prospective case-series with more than 10 patients, length

of follow-up at least 1 month

3. Literature Search Strategy

3.1 Search objective

See Table 2.

3.2 Literature sources

1. ScienceDirect

2. MEDLINE / PubMed

3. CLINICALTRIALS.GOV

4. Cochane Library

5. ResearchGate.net

6. EFIC 2015 abstracts (www.efic.org)

7. http://scenarenfrance.com/

3.3 Search dates

For all databases we search for all records up to 01.02.2019

3.4 Search plan

We search all databases by specified keywords and pick up abstracts. We join search

results for all databases and get list of unique records. We exclude records with unavailable

abstracts or not referred to search goal. We analyse abstracts and exclude unrelevant and

duplicated records. For relevant records we search for fulltext publications. We also include

published conference papers and registered clinical trial results in analysis. We analyze fulltext

publications for eligibility and exclude publications at this stage by reasons: wrong study design,

wrong data analysis, lack of information on study details. Finally we include fulltext publications

in comprehensive clinical analysis.

http://www.efic.org/

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4. Search results

For ScienceDirect search we use keywords: SCENAR, SCENAR therapy, SCENAR pain.

ScienceDirect search results are specified in Table 2. One record was identified in ScienceDirect.

No additional records were identified since last report.

For MEDLINE/PUBMED we use keywords: SCENAR, SCENAR therapy, SCENAR pain.

Medline/PubMed Search results are specified in Table 3. Seven records were identified in

PubMed. No additional records were identified since last report.

For CLINICALTRIALS.GOV we use keywords (other terms): SCENAR. One new clinical

trial record was identified in this database and specified in Table 4.

For Cochrane Library we use keywords: SCENAR. Cochrane Library search results are

specified in Table 5. Four records were identified in Cochane Library.

For ResearchGate.net we use keywords: SCENAR Therapy, SCENAR pain.

ResearchGate.net results are specified in Table 6. Nine records were identified through

ResearchGate.net. One new record was identified and four previously found records were not

identified in database since last report.

We include 9-th congress of the European Pain Federation EFIC (EFIC 2015) abstracts on

SCENAR therapy (see Table 7).

We also search for publications on SCENAR at http://scenarenfrance.com/pages/scenar-

dans-la-structure-de-la-m%C3%A9decine-de-r%C3%A9tablissement

http://scenarenfrance.com/pages/scenar-dans-la-structure-de-la-m%C3%A9decine-de-r%C3%A9tablissement

http://scenarenfrance.com/pages/scenar-dans-la-structure-de-la-m%C3%A9decine-de-r%C3%A9tablissement

SCENAR B13.14

Issue 14 of 19-07-2019 of 51

Records from

ScienceDirect

(n=1)

Records after duplicates removed

(n=68)

Records screened

(n=68)

Records excluded

(n=6)

Full text papers assessed for

eligibility

(n=62)

Fulltext papers excluded with

reasons:

- not a clinical study (n=16)

- improper study design (n=12)

- improper outcomes (n=15)

- improper population (n=5)

Fulltext papers

included in analysis of clinical

performance

(n=5)

Ide

ntifica

tio

nS

cre

en

ing

Elig

ibili

tyIn

clu

de

d

Records from

MEDLINE/PUBMED

(n=7)

Records from

Cochrane Library

(n=4)

Records from

ResearchGate.net

(n=9)

Records from

EFIC 2015

(n=2)

Records from

scenarenfrance.com

(n=55)

Fulltext papers

included in analysis of clinical

safety

(n=9)

Records from

ClinicalTrials.GOV

(n=1)

Picture 1 - Study selection flowchart

SCENAR B13.14

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5. Publication details

5.1 Publications included in clinical performance analysis

Overall 2 fulltext papers and 3 published abstracts with results of clinical trials were

identified through literature search. Additionally, 2 clinical studies were identified through

PMCF procedure.

1) Jaesung Han, Inbo Han. A Comparative Study of the Efficacy between Self-controlled

Energo-Neuro-Adaptive Regulator and Transcutaneous Electrical Nerve Stimulation for

Whiplash Injury. The Nerve.2016.2(2):33-37.

In this randomized controlled prospective study 60 patients (aged 20-50 years old) with

post-traumatic neck pain were assigned to receive either transcutaneous electrical nerve

stimulation (TENS) therapy (28 patients, control group) or SCENAR therapy with SCENAR

device (32 patients, experimental group).

The treatment regimen included 20-min treatment sessions for 4 weeks (3 times per week).

Therapeutic effects were evaluated at each of the assessment points (0, 4, 8, 12 and 16 weeks)

using a visual analogue scale (VAS) pain scores and neck disability index (NDI) scores.

The SCENAR group showed superior pain reduction compared with TENS (SCENAR:

initial mean VAS score; 6.3, final mean VAS score; 2.1, TENS: initial mean VAS score; 6.2,

final mean VAS score; 3.7). Sixteen week NDI scores showed the disability level of the

SCENAR group (9.5) was significantly lower than that of the TENS group (14.3).

SCENAR therapy provided a significant reduction in the intensity of neck pain (VAS) and

disability (NDI) compared with TENS group. SCENAR therapy is superior to the TENS therapy

in reducing and disability for whiplash injury.

No adverse affects were registered in any of intervention groups.

2) R. Schukro, I. Mandl-Krusche, A. Kaider, S. Sator-Katzenschlager (Austria). Benefit in

patients with knee osteoarthritis through adjuvant electro auricular acupuncture vs. Manual body

stimulation with self-controlled energo neuro adaptive regulation (SCENAR®™). EFIC 2015

abstracts. Vienna, Austria, 2-5 September 2015.

In this randomized controlled study 46 patients with knee osteoarthritis were assigned to

electrical auricular acupuncture (EAA) group (15 patients), SCENAR group (14 patients) and the

control group (15 patients). Amount of rescue medication, pain intensity (NRS), range of motion

(ROM) in the sagittal plane and the pain free walking distance in minutes as well as knee

function assessment were evaluated on study day 1, 42 and 70.

Comparing the rescue medication after baseline therapy no significant difference was

found between the three groups (p=0,86). In the control group we found a median of 1 [Q1

25%=1; Q3 75%=2], in EAA group a median of 0 [Q1=0;Q3=3] and in the SCENAR group a

median of 0 [Q1=0;Q3=3]. Highly significant differences of amount of rescue medication were

found on day 42 and 70 comparing EAA group and control group (p<0,001), as well as in the

SCENAR group compared to the control group.

The results of this study show that EAA and SCENAR in combination with medical

analgesic treatment are superior to medical analgesic treatment alone. Pain relief was maintained

one month after the therapy was discontinued in these two complementary methods.



3) Y. Eun, W. Choi the effect of SCENAR and TENS (transcutaneous electrical nerve

stimulation) on the pain relief in patients with chronic neck pain. EFIC 2015 abstracts. Vienna,

Austria, 2-5 September 2015.

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In this study 30 elderly patients with chronic neck pain of more than 3 months duration

were randomized to receive SCENAR therapy (experimental group, 11 patients) or TENS group

(controls, 13 patients) three times a week for two weeks.

The patients were assessed before and after 2-week treatment using three measuring tools

such as Numeric Rating Scale (NRS), Neck Disability Index (NDI), and Range of Motion

(ROM).

The SCENAR group showed significantly improved results in NRS, NDI, and ROM after

intervention, as did the TENS group.(p<0.05) The comparison of mean changes in the SCENAR

group(12.36) before and after intervention showed superior results in the NDI when compared

with the TENS group(3.950).

The findings show that both SCENAR and TENS are effective treatment for patients with

chronic neck pain. Patients who underwent SCENAR had a significant improvement in Neck

Disability Index (NDI) than the TENS group.



4) In Bo Han, Ryoong Huh. SCENAR therapy for myofascial pain syndrome. Abstracts of

WACBE World Congress on Bioengineering 2007, Bangkok, THAILAND.

In this study 202 patients (aged 18-65 years) with myofascial pain syndrome (MPS) were

treated by SCENAR therapy. The mean frequency of this treatment was 3 times a week and the

mean duration time per each treatment was 5 minutes. The mean follow up period was 6 months

(range: 3 months- 16months). The visual analogue scale (VAS) was used to assess the

effectiveness of SCENAR therapy.

The overall improvement of pain was 89%. Especially, the improvement of acute pain was

good, and all patients presenting MPS were satisfactory.



This study is a prospective case-series, not an RCT.

5) In Bo Han, Ji Young Moon, Ryoong Huh, Hye Young Yoo, Sang Sup Chung. The


In this study 340 patients (138 male, 202 female; ages 23-76 years; mean age 43.5 years)

with myofascial pain syndrome were included in this study. All patients were treated by

SCENAR therapy. During the period of SCENAR therapy, none of the patients underwent any

form of therapy excepted for the SCENAR therapy to check the effect of SCENAR therapy. The

study was approved by the institutional review board of the University of Pochon CHA,

Sungnam, Korea.

Therapeutic effects were evaluated before treatment, at 1 week, and at month after the end

of treatment using a visual analogue scale (VAS).

The patients treated by SCENAR showed a significant improvement of performance in

pain score (VAS) and in the evaluation of myofascial trigger point characteristics. A significant

increase in the ROM was also achieved. One week after the end of the SCENAR therapy, 296

patients (87.2 %) had experienced effective pain relief, and these improvements persisted at 1

month pos-treatment. The patients were classified into subgroups; low back pain subgroup and

neck pain group including shoulder pain. The reduction in the pain intensity was achieved in

83.1% among the low back pain subgroup (n=95) and in 88.7% among the neck pain subgroup

(n=245). The effect of SCENAR therapy in cases of neck pain was superior to that in cases of

low back pain. No serious complications occurred during the treatment.

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Results from PMCF procedure:

6) Tarakanov A.A., Efremov V. V., Nelassov N.J., Tarakanov V.A., Karkoshko T.A.,

Erofeeva A. V. Transdermal neurostimulation in dorsalgia patients at pre-hospital stage of

medical care. Abstracts of a joint venture of the l3th European Congress of Internal Medicine of

the European Federation of Internal Medicine (EFIM) and the 82nd Annual Meeting of the Swiss

Society of General Internal Medicine (SGIM), 14-16 May 2014 Geneva, Switzerland.

In this multicenter study patients with dorsalgias at pre-hospital stage of medical care

received either SCENAR therapy (101 patient in two experimental groups) or ketorolac

tromethamine 2 ml (30 mg) i. m. as pain management therapy (25 patients, Group 3) or

ketoprofen 2 ml (100 mg) i. m. (54 patients, Group 4). Dynamics of clinical symptoms and

intensity of analgesia in 10 - 30 minutes after procedure or intake of pain killer were analyzed.

Before treatment subjective estimate of pain according visual analogue scale in groups was

5-7 points. Lowering of pain level for 55-60% of initial intensity after treatment was noted in all

groups; a great regress of clinical symptoms was registered. SCENAR-therapy in 1st and 2nd

groups was comparable in efficacy with medicamental methods. Therefore SCENAR-therapy in

dorsalgia patients at pre-hospital stage of medical care was simple and effective method for pain

relief.



7) Efectos sobre la sensibilización central de la terapia de regulación neuroadaptativa.

Tesis Doctoral Carlos Udina, Universidad Rey Juan Carlos, Madrid, 2017.

In this randomized controlled double blind study, 37 adult women with diagnosis of

fibromyalgia were randomized to receive either SCENAR therapy (20 patients, experimental

group) or placebo (17 patients, control group). Patients in the experimental group were treated

with 35-min SCENAR sessions two times a week. Overall 12 variables concerning pain levels,

life quality and function were evaluated.

SCENAR was effective in management of central pain in fibromyalgia patients.

5.2 Publications included in Safety analysis

Overall 9 publications were identified for safety analysis only

1) J. N. Chernov, A.P. Balanovsky, S.V. Svirko, A.V. Chernov, I.S. Chernova, G.T.

Kairov. Advantages of scenar-therapy in treating chronic adnexitis // SCENAR-therapy and

SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles.

In this study 60 women with chronic adnexitis were treated with SCENAR as monotherapy

(30 patients in experimental group) or with standard medical treatment (30 patients, control

group). Average duration of staying in the hospital after medical treatment was 10 days, after

monotherapy with SCENAR – about 3 days. All treatment course was 17-30 days long. No

allergic reactions or other complications were observed in SCENAR group. In control group 6

patients had developed some reactions on drugs used.

We include this publication in safety chapter as long as no such indication specified in the

IFU and this kind of therapy can’t be recommended in absence of good clinical evidence.


2) A.V. Tarakanov, E. V. Kutovaia. SCENAR Therapy of chronic insomnia and

neurocirculatory asthenia in emergency doctors // Nondrug medicine – 1/2007. St. Pertersburg,

Russia.

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In this randomized controlled study, 73 patients with insomnia were treated either with

SCENAR (20 patients, experimental group) or with Zopiclone soporific medicine (53 patients,

control group). Treatment course was 10 days long.

Use of soporific medicine and SCENAR-therapy for treatment of chronic insomnia reliably

improved almost all the subjective characteristics of sleep (excluding its duration). The

comparative analysis of the results showed that SCENAR-therapy influences mostly intra- and

postsomnic disorders. Zopiklon and SCENAR-therapy have similar positive therapeutic effect on

insomnia. During the research none of the patients cancelled the treatment or treatment was not

cancelled due to side effects. The effect of SCENAR-therapy lasts for 1-4 months.




3) T.A. Shepeleva, A.E. Stolbov. SCENAR in treating chronic adnexitis. SCENAR-

therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004. Collection of Articles.

In this study 30 women with chronic adnexitis were treated either with medications

(indomethacin, ortophen, diclofenac, magnesium sulfate, reopyrinym, donalgin, lydazum,

immunomodulators, desensitizing and sedative medications) combined with physiotherapy –

quartz, electrophoresis, UHF currents, and ultrasound (10 patients, control group), or with

SCENAR therapy alone (10 patients) or with SCENAR-therapy and homeopathic medications

(10 patients).

By the end of the treatment course (3-4 weeks) only 3 women from the first group had

been reported to have no pain syndrome, pains had considerably decreased by 4 women, in 4%

of cases premenstrual and ovulatory syndromes had been reduced. 6 patients still didn’t have a

normal two-phase menstrual cycle during the first three months after the treatment. 4 patients

had to repeat courses of treatment and then undergo resort treatment.

In the second group pain syndrome decreased considerably after 2-3 treatments, after 4-5

treatments there was a short-term appearance or a slight intensification of pains, after the 6th

treatment pain completely disappeared.

Menstrual cycle was restored by all the patients. During a year afterwards there were no

ovulatory or premenstrual syndromes. During the first 3 months a two-phase menstrual cycle

was restored by eight women, two patients needed an additional treatment course in 3 months for

a two-phase cycle’s restoration.

In the one-year follow-up 2 women from the second group and 3 women from the third

group became pregnant whereas There were no cases of pregnancy among the patient from the

control group.




4) Ryoong Huh, In Bo Han. SCENAR therapy for lymphedema // Abstracts of WACBE

World Congress on Bioengineering 2007, Bangkok, THAILAND.

In this study SCENAR therapy was performed in 28 patients with lymphadema caused by

radiation treatment of cancer.

All patients were female and were performed radiation treatment due to breast cancer in-7

patients, cervical cancer in 13 patients, and ovarian cancer in 8 patients. The mean age was 53.7

years (range: 37-65 years). The mean frequency of SCENAR therapy was 4 times a week and the

mean duration time per each treatment -was 8 minutes. The mean follow up period was 7 months

(range: 3 months-18months). The circumference of affected extremities was measured before

and after treatment. The overall improvement of lymphadema was 79% and the pain associated

with lymphadema also improved in 85 % of patients. This study suggested that the SCENAR

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device impulse helps fluid come out of the lymphatic system and improves the microcirculation.

SCENAR device also eliminates inflammatory process in the lymph nodes. Therefore, -

SCENAR therapy would be very useful method to deal with lymphedema.




5) L.V.Borovkova, I.E.Holmogorova, V.D.Uchaikina, E.V.Chelnokova. SCENAR-therapy

clinical effectiveness for the patients with tubal-peritoneal infertility.

In this study 111 patients with tubal-peritoneal infertility were observed and treated with

laparoscopy (30 patients, controls), laparoscopy and SCENAR (39 patients) and SCENAR alone

(42 patients). Overall 81 patients were in experimental groups.

Autonomic status in the second and the third groups normalized after SCENAR-therapy.

The indices in the first group didn’t change.

The psychological state was analyzed before and after the treatment in all patients. There

was marked improvement of all components of the psychological well-being index (anxiety,

depression, self-control, health in general, emotional security, vital power). There was a 16%

increase in the first group, 48% - in the second and 43% in the third one.

The dynamics of indices that influence the patients’ lives considerably (paramenia,

dyspareunia, pains in the intermenstrual period, defecation disorders) were also analyzed. The

positive dynamics was more considerable in the groups where SCENAR-therapy was used as

compared with the control group. Results of SCENAR-therapy both after laparoscopy

operations, and without it, allow us to exclude laparoscopy as a method of fallopian tubes

correction, provided that there was an absence of hydrosalpinxes and that infertility period did

not exceed 3 years. P patients from the second group (51%) and from the third group (45%)

achieved the best results in the restoration of uterine tubes clearance and the ability to conceive.




6) N.N.Usalyova, L.V.Klimova, A.V.Tarakanov. SCENAR-Therapy Effects on Blood


Compression Injuries Complicated by Acute Renal Failure // Reflexology Journal, Issue No: 3

(7), 2005, Moscow, Russia.

In this study, 112 patients with acute renal failure caused by compression injury were

observed and treated with standard intensive therapy, from which 46 patients received standard

therapy alone (control group), 41 patients received Isradipine 2.5 mg twice daily in complex

treatment (group 1) and 25 patients received isradipine and SCENAR therapy.

Blood pressure characteristics were registered on admission, on the 1-2 day of diuresis

recovery and on transfer to the relevant department. The blood samples for biochemical tests

were taken on admission and on the 1-2 day of diuresis recovery.

SCENAR-therapy in combination with Isradipine (2.5 mg twice daily) administered

sublingually was considered the most effective method for adjusting blood pressure in patients

with acute renal failure following the compression injury.




7) Borovkova L.V., Kholmogorova I. E., Umiarov R.V. The Effectivity Of The Electro-

Impulse Therapy With The Help Of SCENAR Device On Patients With External Genital

Endometriosis (EGE).

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In this study 241 women with external genital endometriosis (EGE) were observed and

treated. According to the Classification of the American society on fertility 60 (24.8%) of the

patients were with 1st degree of severity of ЕGE, 50 (20.7%) - with 2nd degree, 111 (46%) -

with 3rd degree and 20 (8.5%) - with 4th degree.

A laparoscopy was made to all patients on the first stage of the treatment according to the

spread of EGE: a coagulation of EGE sites, resection of the endometrial cists of the adnexa with

a coagulation of the bed, incision of the adhesions. On the second stage of the treatment the

patients with EGE were divided into two groups.

In the first group – 141 patients took hormonomodulizing preparations for 6 months. In the

second group 100 patients were treated by SCENAR therapy (1 to 3 courses with 1-month

interval).

The recurrence rate of the disease after the hormonomodulizing therapy in a period from 6

months to 1.5 years was 38.2% (22.8%, 33.3%, 37.7% and 60% at І, ІІ, ІІІ, and ІV degrees of

severity respectively). Only 25.5% of the patients with EGE become pregnant 6 months to 1 year

after the hormonomodulizing therapy.

No recurrence of the disease was detected up to 1.5 years in the patients with EGE, treated

with SCENAR in the postoperative period. 68% of the patients become pregnant (82%, 79%,

35% and 22% at І, ІІ, ІІІ, and ІV degrees of severity respectively).




8) Yurova Y.V., Tarakanov A.V. The effectiveness of SCENAR biofeedback

transcutaneous electroneurostimulator in treatment of burn patients // “Emergency Medical Aid”

– Russian research and practice journal, 2006, volume 7, No.3 – p. 138.

In this study 40 patients with burns were observed and treated. In the control group 23

patients received non-narcotic analgesics only as analgesic treatment. In the experimental group

17 patients received a combination of non-narcotic analgesics and SCENAR therapy.

The results showed that painful sensation was reduced in 94% of the primary group (16

patients). In the control group, where non-narcotic analgesics only were used as analgesic

therapy, a sufficient analgesic effect was noted only in 56% of the patients (13 patients). 44% of

the patients (10 people) asked for additional analgesic injections due to pain complaints.

Idiosyncrasy to eradiated electric current when treated with SCENAR was found in 1 patient

(unpleasant sensations in the affected area). One patient refused to be injected – SCENAR

treatment was sufficient to eliminate painful sensations in wounds.




9) Los E.G., Tarakanov A.V., Hatisova E.V. Using SCENAR-therapy for treating

hypertension crisis in pre-hospital period // Reflexology – 2008 – No. 3-4 – pp. 23-26.

In this study 97 patients with uncomplicated hypertensive crises in pre-hospital period

were treated by SCENAR. The patients were selected using the technique of random sampling.

Patients’ average age was 60.2±1.3, among them 71 women (73%) and 26 men (27%).

Immediately after the SCENAR-manipulation a significant arterial pressure decreasing was

achieved, a decrease in frequency of complaints from headaches, heartaches, head noises,

photopsia, nausea, vomiting and dizziness was stated. Frequency of cases of facial hyperemia

also dropped in 10 minutes. The frequency of heartaches, photopsia, nausea, and vomiting

decreased to the greatest degree in 20 minutes after the manipulation.



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Risk/Benefit ratio estimation

For treatment of myofascial pain there was clinical significant benefit of the Device in

reducing pain levels, but well-formed RCTs required for better clinical evidence. As no device-

related side effects was observed in the identified studies, the Device can be used as an adjunct

for pain management therapy.

[Desai MJ, Saini V, Saini S. Myofascial Pain Syndrome: A Treatment Review. Pain Ther

(2013) 2:21–36. PMID: 25135034 (on limited evidence of treatment modalities)]

For treatment of post-operative and post-traumatic acute pain there was significant benefit

of the Device in reducing pain levels. There was also significant clinical benefit in improvement

of functional indices. As no Device-related side effects was observed in the identified studies,

the Device can be used as a supplemental therapy for pain management for post-traumatic

rehabilitation. There is also clinical support for use the Device as monotherapy for post-

traumatic pain conditions.

[Johnson MI, Paley CA, Howe TE, Sluka KA. Transcutaneous electrical nerve stimulation

for acute pain. Cochrane Database of Systematic Reviews 2015, Issue 6. Art. No.: CD006142]

For the treatment of the osteoarthritis of the knee, there was clinical benefits of the Device

in reducing pain medication observed. As no Device-related side effects was observed in the

identified studies, the Device can be used as a supplemental therapy for pain management for

knee osteoarthritis.

[Zeng C, Li H, Yang T, Deng ZH, Yang Y, Zhang Y, Lei GH. Electrical stimulation for

pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis

Cartilage. 2015 Feb;23(2):189-202. PMID: 25497083]

For the treatment of fybromialgia there was clinical benefits of the Device in reducing pain

levels and improving functional indices. There is a preliminary evidence of clinical benefit of

SCENAR in fybromialgia.

For treatment of acute pain there was clinical benefits of the Device in reducing pain levels

at pre-hospital stage.

For treatment of chronic pain there was clinical benefits of the Device in reducing pain

levels and improving functional indices. There is a preliminary evidence of SCENAR clinical

effect in patients with chronic neck pain.

SCENAR B13.14

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Appendix

Database search protocols

ScienceDirect search

Link:

http://www.sciencedirect.com/search?qs=InterX&authors=&pub=&volume=&issue=&page=&o

rigin=home&zone=qSearch

Date: 01/02/19

Keywords: SCENAR, SCENAR Therapy, SCENAR Pain

Table 2

# Authors, Title, Publication

1 Influence of SCENAR-therapy on the GABA content, antioxidant and epileptic activities

European Neuropsychopharmacology, Volume 12, Supplement 3, October 2002, Page 426

M. Maklesova, A. Kucherenko, M. Vakulenko, I. Grinberg

[not a clinical study]

MEDLINE / PubMed search

Link: https://www.ncbi.nlm.nih.gov/pubmed/

Date: 01/02/19

Keywords: SCENAR, SCENAR Therapy, SCENAR pain, SKENAR

Table 3


1 . [The comparative effectiveness of the application of various methods for electrical muscle

stimulation in the patients presenting with juvenile cerebral palsy].

Barbaeva SN, Kulishova TV, Eliseev VV, Radchenko NV.

Vopr Kurortol Fizioter Lech Fiz Kult. 2014 Jul-Aug;(4):43-6. Russian.

PMID: 25314769

[population]

2 Effect of artrofoon and SCENAR therapy on parameters of LPO and antioxidant system of

the blood in patients with peritonitis in postoperative period.

Varakanov TA, Luspikayan SKh, Milyutina NP, Rozhkov AV.

Bull Exp Biol Med. 2009 Sep;148(3):497-500. English, Russian.

PMID: 20396722

[outcomes]

3 The use of electronic biofeedback for the management of post-herpetic neuralgia—a report

of 3 cases.

Ing MR.

Hawaii Med J. 2007 Sep;66(9):232, 234.

PMID: 20879466

[study design]

4 [The effectiveness of SCENAR therapy in complex treatment of duodenal ulcer, and the

mechanisms of its action].

Tsimmerman IaS, Kochurova IA, Vladimirskiĭ EV.

Klin Med (Mosk). 2006;84(7):35-41. Russian.

PMID: 16924799

[outcomes]

5 [The treatment of neurogenic bladder dysfunction with enuresis in children using the

SKENAR apparatus. (self-controlled energy-neuroadaptive regulator)].

Lebedev VA.

Vopr Kurortol Fizioter Lech Fiz Kult. 1995 Jul-Aug;(4):25-6. Russian.

PMID: 8779182

http://www.sciencedirect.com/search?qs=InterX&authors=&pub=&volume=&issue=&page=&origin=home&zone=qSearch

http://www.sciencedirect.com/search?qs=InterX&authors=&pub=&volume=&issue=&page=&origin=home&zone=qSearch

https://www.ncbi.nlm.nih.gov/pubmed/

SCENAR B13.14

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[no information available]

6 [Biocontrollable electrostimulation in clinics of nervous diseases].

Lishnevskiĭ SA.

Lik Sprava. 2002;(7):68-70. Russian.

PMID: 12587312


7 [Testing of the SKENAR-032 apparatus (a neuroadaptive electrostimulator)].

Filimonov RM, Kisova LV.

Vopr Kurortol Fizioter Lech Fiz Kult. 1993 Sep-Oct;(5):62-3. Russian. No abstract

available.

PMID: 8266675


CLINICALTRIALS.GOV

Link: https://clinicaltrials.gov/

Date: 01/02/19

Keywords (Other Terms): SCENAR

Table 4


1 Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome (SCENAR1)

Official Title: Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal

Pain Syndrome

ClinicalTrials.gov Identifier: NCT03755817

First Posted: November 28, 2018

Study Type : Interventional (Clinical Trial)

Estimated Enrollment : 60 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Participant)

Primary Purpose: Treatment

Official Title: Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal

Pain Syndrome

Actual Study Start Date : October 2, 2018

Estimated Primary Completion Date : September 2020

Estimated Study Completion Date : September 2020

[study not complete, no results posted]

Cochane Library

Link: https://www.cochranelibrary.com/

Date: 01/02/19

Keywords: SCENAR

Table 5


1 The effectiveness of SCENAR therapy in complex treatment of duodenal ulcer, and the

mechanisms of its action

Tsimmerman IaS , Kochurova IA and Vladimirskiĭ EV

Klinicheskaia meditsina, 2006, 84(7), 35

[duplicated]

2 Scenar -technology for cerebral edema (CE) in cancer patients (PTS).

Zaydiner B and Savina S

Supportive care in cancer, 2015, 23(1 SUPPL. 1), S154


3 Effect of artrofoon and SCENAR therapy on parameters of LPO and antioxidant system of

https://clinicaltrials.gov/

https://www.cochranelibrary.com/

SCENAR B13.14

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the blood in patients with peritonitis in postoperative period

Varakanov TA , Luspikayan SKh , Milyutina NP and Rozhkov AV

Bulletin of experimental biology and medicine, 2009, 148(3), 497

[duplicated]

4 The treatment of neurogenic bladder dysfunction with enuresis in children using the

SKENAR apparatus. (self-controlled energy-neuroadaptive regulator)

Lebedev VA

Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury, 1995, 4, 25

[duplicated]

ResearchGate.net

Link: https://www.researchgate.net/search/publications?q=SCENAR%252Btherapy

Date: 01/02/19

Keywords: SCENAR, SCENAR Therapy, SCENAR pain

Table 6


1 Han, Jaesung & Han, Inbo. (2016). A Comparative Study of the Efficacy between Self-

controlled Energo-Neuro-Adaptive Regulator and Transcutaneous Electrical Nerve

Stimulation for Whiplash Injury. The Nerve. 2. 33-37. 10.21129/nerve.2016.2.2.33.

[online publication available at http://thenerve.net/journal/view.php?number=72]

2 Lee, Jong-Ha & Kwon, Jeong-Gook & Keum, Dong-Ho. (2015). A Case Report of Neck

Pain Patient with Klippel-Feil Syndrome by Cervical Manipulation Treatment. Journal of

Korean Medicine Rehabilitation. 25. 175-180. 10.18325/jkmr.2015.25.2.175

[study design]

3 Zhukova, E.A. & Shabunina, E.I. & Avdeeva, N.V. & Lyutov, N.V. & Kulik, N.N. &

Syresina, O.V.. (2011). The Effect of SCENAR-Therapy on Dynamics of Clinic and

Endoscopic Vegetative Indexes in Young Children and Preschool Children with

Gastroduodenal Diseases. Sovremennye Tehnologii v Medicine. 2011. 77-82

[population]

4 Engelbert, C.W.. (2005). SCENAR - Activation of healing processes by individual impuls

therapy. 34. 25-28


5 Prinz, Jorg. (2014). SCENAR for Pain Relief and Chronic Illness. The New Zealand

Journal of Natural Medicine. 2014. Issue 13. p. 26-27


6 R Ing, Malcolm. (2007). The use of electronic biofeedback for the management of post-

herpetic neuralgia-a report of 3 cases. Hawaii medical journal. 66. 232, 234

[duplicate]

7 Engelbert, C.W.. (2006). SCENAR and homeosiniatria. 35. 72-76


8 Lazik, D & Luther, S & Tiedje, H & Kittel, Rene & Badtke, G. (2006). Use of SCENAR in

musculo-skeletal problems in heavy athletics. 35. 67-71


9 M Gurevich, V Gurevich.

Effective Treatment of Drug Refractory Functional Dyspepsia Using Scenar Therapy: A

Case Report.

J of Pharmacol & Clin Res. 2017; 4(5): 555647. DOI: 10.19080/JPCR.2017.04.555647

[study design]

EFIC 2015 abstracts:

Link: http://efic.kenes.com/scientific-information/efic-2015-abstracts#.WdyntLj6gwA

Keywords: SCENAR

https://www.researchgate.net/search/publications?q=SCENAR%252Btherapy

http://thenerve.net/journal/view.php?number=72

http://efic.kenes.com/scientific-information/efic-2015-abstracts#.WdyntLj6gwA

SCENAR B13.14

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Table 7


1 R. Schukro, I. Mandl-Krusche, A. Kaider, S. Sator-Katzenschlager (Austria)

Benefit in patients with knee osteoarthritis through adjuvant electro auricular acupuncture

vs. Manual body stimulation with self-controlled energo neuro adaptive regulation

(SCENAR®™)

EFIC 2015 abstracts. Vienna, Austria, 2-5 September 2015

2 Y. Eun, W. Choi the effect of SCENAR and TENS (transcutaneous electrical nerve

stimulation) on the pain relief in patients with chronic neck pain

EFIC 2015 abstracts. Vienna, Austria, 2-5 September 2015

Publications at scenarenfrance.com


1 Sang-Yhun Ju, Whan-Seok Choi, Hae-Jin Lee

A Pilot Study of the Effectiveness of 'Butterfly Technique' of SCENAR

Therapy on Heart Rate Variability

[outcomes]

#83

2 J. N. Chernov, A.P. Balanovsky, S.V. Svirko, A.V. Chernov, I.S. Chernova,

G.T. Kairov

ADVANTAGES OF SCENAR-THERAPY IN TREATING CHRONIC

ADNEXITIS

SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.

Collection of Articles

[safety only]

#48

3 Tarakanov A.V., S.H. Luspikayan

Activation of antimicrobial endogenous protection in patients with pyogenic

surgical pathology

Current problems in surgery, Abstracts from the II Conference of the

Department of surgical diseases, State Medical University of Rostov

Rostov, 2006, Russia

[outcomes]

#8

4 M.V. Ovsyannikov. A.V. Tarakanov, N.P. Milyutina, Ya.Z. Grinberg, S.L.

Maslovskiy, G.A. Tarakanova

Antioxidant and membrane protecting effects of SCENAR-therapy in treating

opium addiction

[outcomes]

#69

5 S. A. Lishnevski

Biocontrollable electrostimulation in clinics of nervous diseases

Likarska Sprava 2002;(7):68-70. Kiev, Ukraine

[duplicate]

#2

6 Elena Rassomakhina

COMBINED APPLICATION OF SCENAR THERAPY AND

KINESIOTHERAPY

[outcomes]

#19

7 A.A. Lebedenko, A.V. Tarakanov, N.P. Milutina

COMBINED TREATMENT OF THE INFANTILE BRONCHIAL ASTHMA

[outcomes]

#67

8 Lyan V.N., Lyan N.V., Zaidiner B.M., Kulizhskiy B.P.

Chronic Fatigue Syndrome (CFS)

[outcomes]

#23

9 Lopatina A. B.

Comparison Of The Effectiveness Of SMC And SCENAR-Influence In

#32

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Recovery Of The Body Functions of Sportsmen After Training

[outcomes]

10 A. V. Tarakanov, S. Kh. Luspikayan, N. P. Milyutina, and A. V. Rozhkov

Effect of Artrofoon and SCENAR Therapy on Parameters of LPO and

Antioxidant System of the Blood in Patients with Peritonitis in Postoperative

Period

Bulletin of Experimental Biology and Medicine, Vol. 148, Suppl. 1, 2009

[duplicate]

#63

11 Luspikayan S.H., Tarakanov A.V., Voronkin D.A.

Effect of arthrophon with use of Transcutaneous Neurostimulation on values of

lipid peroxidation at complex post-surgical therapy in patients with purulent

appendicular peritonitis

Pharmacology – Practical Healthcare, Issue No: 7, September 2007

[outcomes]

#9

12 Boris Zaidiner, Ilia Baranovsky, Darya Leontyeva, Irene Petrenko

Electric Device For Bisphosphonate-Induced Osteonecrosis

Abstracts of the 2008 International MASCC/ISOO Symposium

[outcomes]

#15

13 Kutovaia E. V., Tarakanov A.V.

Health conditions of emergency aid doctors. Chronic Insomnia

Emergency Aid: reality and perspectives Voronej, 2006

Voronej, 2006, Russia

[duplicate]

#11

14 M. Maklesova I , A. Kucherenko 1 , M. Vakulenko 1 , I. Grinberg

Influence of SCENAR-therapy on the GABA content, antioxidant and epileptic

activities

European Neuropsychopharmacology, Volume 12, Supplement 3, October

2002, Page 426

[duplicate]

#62

15 L.V. Borovkova, A.A. Artifeksova, S.O. Kolobova

Influence of SCENAR-therapy on the pregnancy course, labor, state of a

neonate and a first-year child in women with miscarriage of infectious genesis

Russian reporter of Gynaecologists and Obstetricians 2, 2009

[outcomes]

#50

16 Kharitonov S.A., Korolyov V.A., Tarakanov A.V.

Modern Therapies for burn wounds

“Emergency Medical Aid” - Russian research and practice journal – 2006,

volume 7, No. 3. – pp. 133-134.


#73

17 A.V. Tarakanov, E.G. Los

Multifactor mechanism of SCENAR-analgesia

Reflexology Journal, Issue No: 3 (7), 2005

Moscow, Russia

[study design]

#6

18 Ryoong Huh, In Bo Han

Non-Invasive Treatment of Spinal Pain


#82

19 Boris Zaidiner, Ilia Baranovsky, Nicolay Lyan

One Biophysical Option in Fatigue

Support Care Cancer (2005) 13: 401–483


#12

20 Tarakanov A., Milyutina N., Tarakanova T., Musieva L., Kartashova N.,

Miktadova N.

#22

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Perspectives Of The Application Of The Transcutaneous Electro-stimulation

With Biofeedback In Cardiology


21 Jakov Grinberg

Physical influencing factors in SCENAR-therapy. Application sound therapy


#57

22 T.D. Tarakanova, A.A. Lebedenko, A.V. Tarakanov

ROLE OF AUTONOMIC DYSFUNCTION SYNDROME SCENAR-

THERAPY IN VARIOUS SOMATIC PATHOLOGY

[population]

#33

23 A.V. Tarakanov, E. V. Kutovaia

SCENAR Therapy of chronic insomnia and neurocirculatory asthenia in

emergency doctors

Nondrug medicine – 1/2007. St. Pertersburg, Russia

[safety only]

#10

24 O.A. Maljushko, J.E. Repilo

SCENAR AND ANTIHOMOTOXIC MEDICATIONS IN THE

PREMENSTRUAL SYNDROM THERAPY



[study design]

#51

25 A.V. Tarakanov, L.H. Musieva, A.V. Iljin, N.P. Milutina

SCENAR AND EARLY POSTINFARCTION ANGINA PECTORIS

[study design]

#66

26 T.A. Shepeleva, A.E. Stolbov

SCENAR IN TREATING CHRONIC ADNEXITIS


Collection of Articles.

[safety only]

#52

27 A.V.Tarakanov, A.Ya.Cherchago, R.Kuzmova, T.Forostyan, E.N.Kutovaya

SCENAR PSYCHOUNITROPE EFFECTS

[study design]

#61

28 R YOONG HUH, INBOHAN

SCENAR THERAPY FOR LYMPHEDEMA

Abstracts of WACBE World Congress on Bioengineering 2007, Bangkok,

THAILAND

[safety only]

#81

29 INBOHAN, RYOONG HUH

SCENAR THERAPY FOR MYOFASCIAL PAIN SYNDROME

Abstracts of WACBE World Congress on Bioengineering 2007, Bangkok,

THAILAND

[included]

#80

30 Perfiliev U.I., Krasnopolskaya I.G., Starovoitov U.U.

SCENAR THERAPY IN TREATMENT OF MYOPIA AND

HYPERMETROPIA IN SCHOOLCHILDREN

[population]

#27

31 Maljushko O., Repilo U.

SCENAR and Antihomotoxic Preparations In Premenstrual Syndrome Therapy

[duplicate]

#31

32 N.G. LIPSKAYA

SCENAR and OLM-1 – THE BASIS FOR RECOVERY OF ATHLETES

AFTER TRAINING

[study design]

#24

SCENAR B13.14

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33 Tarakanov A.V.

SCENAR and burn patients. Mechanism of action in terms of the functional

systems theory

Non-pharmaceutical medicine – 2006 – No. 4 – pp. 23-25.


#74

34 L.V.Borovkova, I.E.Holmogorova, V.D.Uchaikina, E.V.Chelnokova

SCENAR-THERAPY CLINICAL EFFECTIVENESS FOR THE PATIENTS

WITH TUBAL-PERITONEAL INFERTILITY

[safety only]

#47

35 V.V. Bakaras, J.A. Petrov, S.I. Petrova

SCENAR-THERAPY EFFECTIVENESS IN UTERUS MYOMA



[outcomes]

#53

36 V.N. Sokurenko, R.N. Chuprina, S.P. Goncharova

SCENAR-THERAPY IN TREATING STERILITY



[outcomes]

#54

37 S.V. Moiseev

SCENAR-Technology and Sports Medicine


#34

38 Grinberg Y.

SCENAR-Therapy And SCENAR-Diagnostics


#39

39 N.N.Usalyova, L.V.Klimova, A.V.Tarakanov

SCENAR-Therapy Effects on Blood Pressure and State of the Blood Plasma

Oxidant-Antioxidant System in Patients with Compression Injuries

Complicated by Acute Renal Failure

Reflexology Journal, Issue No: 3 (7), 2005, Moscow, Russia

[safety only]

#70

40 L.V.Klimova, A.V.Tarakanov, A.V. Kartasheva, N.N.Usalyova

SCENAR-therapy effect on the state of the blood plasma redox balance in

patients with organ ischemic injury

[duplicate]

#58

41 B.P.Kulizhskiy S.S.Kulizhskaya A.I.Maar O.V.Minayev

SCENAR-therapy in Ischemic Stroke Rehabilitation

[outcomes]

#59

42 A.V. Tarakanov, A.V. Ilyin, N.V. Kartasheva, L.V. Klimova, L.H. Musieva

THE DEPENDENCE OF THE OXIDATIVE STRESS ON THE NUMBER

OF STROKES IN EARLY POSTINFARCTION ANGINA PECTORIS

Skoraya Meditsinskaya Pomosch (Emergency) journal. - 2009. - № 2 – pp. 62-

65

[duplicate]

#78

43 TREMBACH A.B., SAVINKOVA V.A.

THE INFLUENCE OF THE BIOCONTROLLED ELECTROSTIMULATION

ON THE SPEEDPOWER

QUALITIES OF THE WEIGHT-LIFTERS OF HIGH QUALIFICATION


#35

44 J.A. Petrov, S.I. Petrova, V.V. Bakaras

TREATING LACTATIONAL MASTITIS WITH SCENAR-THERAPY



#55

SCENAR B13.14

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[study design]

45 Boris Kulizhskiy, O.V.Minaev

The Analysis of Peripheral Blood Changes Following SCENAR-Treatment


#30

46 Coleman S

The Combination Of SCENAR And Activity Based Program For The

Rehabilitation Of Individuals Affected By Paralysis

[study design]

#28

47 Borovkova L.V., Kholmogorova I. E., Umiarov R. V.

The Effectivity Of The Electro-Impulse Therapy With The Help Of SCENAR

Device On Patients With External Genital Endometriosis (EGE)

[safety only]

#38

48 In Bo Han, Ji Young Moon, Ryoong Huh, Hye Young Yoo, Sang Sup Chung

The Efficacy of SCENAR Therapy for Myofascial Pain Syndrome

[included]

#79

49 Yurova Y.V., Tarakanov A.V.

The effectiveness of SCENAR biofeedback transcutaneous

electroneurostimulator in treatment of burn patients

“Emergency Medical Aid” – Russian research and practice journal, 2006,

volume 7, No.3 – p. 138.

[safety only]

#76

50 A.J. Petrov, V.V. Bakaras, S.I. Petrova

USING SCENAR IN TREATING OVARY CYSTS



[study design]

#56

51 Tarakanov A.V., Grinberg I.Z., Milyutina N.P.

Universal mechanisms of SCENAR-effect in oxidative stress

Reflexotherapy – 2003. No. 4 (7) – pp. 41-45.


#77

52 Use of SCENAR treatment for various bone fractures in children

[population]

#20

53 Yakovenko P.

Use of SCENAR treatment in football and basketball master teams


#36

54 U.U. Starovoitov, U. I. Perfiliev, S.V. Novgorodskii

Use of the External Toothbrush Electrode for the Prevention and Treatment of

Periodontal Diseases

[study design]

#29

55 Los E.G., Tarakanov A.V., Hatisova E.V.

Using SCENAR-therapy for treating hypertension crisis in pre-hospital period

Reflexology – 2008 – No. 3-4 – pp. 23-26

[safety only]

#75

SCENAR B13.14

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ANNEX 2

Name: Тarakanov Alexandr Viktorovich

Business address: 99 Petrovskaya Street, Taganrog 347900, Russian Federation

Tel.: (8634) 32-89-29, +7 905 486 6111


Web-site: http//www.scenar.com.ru

Date of Birth: May 5, 1952.

Position

Head of the Emergency Department at the Advanced Training Faculty for physicians (Rostov

State Medical University, Russia), Professor, MD.

Director of SCENAR-therapy Research Institute (RITM OKB ZAO, Taganrog, Russia).

Clinical pharmacologist in Emergency Hospital No2 (Rostov-on-Don, Russia).

Qualifications

Clinical pharmacology

Anesthesiology and critical care medicine

SCENAR-therapy

Education

Clinical residency in anesthesiology and critical care medicine.

MD, professor in clinical pharmacology.

Research interests

1981-1991 – head of the research team on introducing new drugs in clinics and hospitals of the

Rostov Medical University and other hospitals in Rostov-on-Don (Pharmacological Committee

of the USSR Ministry of Health).

1980-1985 – carried out researches on pharmacological anaesthesia, analgesia potentiation, and

central hemodynamic indices in hypoxic patients in postoperative period, acute myocardial

infarction. Put forward the anesthetic technique that includes using tricyclic antidepressants

imipramine and fentanyl. Received the patent ‘Anesthetic technique at managing pain in

myocardial infarction and surgeries’ (Bulletin ‘Inventions, Breakthrough’ – 1983 – № 40 – p.23.

Copyright certificate № 1050707) and wrote a thesis ‘Pharmacological analysis of

antidepranalgesia’ (thesis for candidate of medical science, Rostov-on-Don – 1984 – 172 p.).

1985-1995 – carried out researches on effect of clophelin on ketamine anesthesia in anoxia and

oxidative stress in the experiment and clinics, pharmacological analysis of mechanisms on

potenting the effect of narcotic analgesic. Received the patent ‘Anesthetic technique with the use

of clophelin and ketamine’ (Bulletin ‘Inventions, Breakthrough’ – 1990 – № 6 – p.29. Copyright

certificate № 1560217) and wrote a doctoral thesis ‘Pharmacological regulation of body stress

limiting antinociceptive systems in the contex of psychounitropism’ (thesis for doctor of medical

science, Moscow – 1994 – 427 p.).

Since 2001 – head of the scientific research line associated with the non-drug treatment

modalities in the emergency situations. First, it involves Self-Controlled-Energo-Neuro-

Adaptive-Regulaton modality (SCENAR). Studies the effect of informational stimulation

methods (SCENAR-therapy) used as a monotherapy, as well as a combined with other well-

known techniques and methods on patients with severe acute disease at pre- and post-hospital

stages. Practical effectiveness of the treatment modality: safe, physiological, cost-effective, can

be combined with orthodox treatment modalities, as well as used as a monotherapy, in case other

therapies are ineffective.

Supervisor of the following scientific theses: Comparative analysis of different methods

efficiency in premature postinfarction stenocardia treatment (2003); Intensive therapy of arterial

SCENAR B13.14

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hypertension in patients with acute renal failure caused by compression injury (2005); Using

Zopiclone and SCENAR-therapy for treating chronic insomnia in emergency doctors (2007);

Correcting free-radical processes in acute myocardial Q-infarction patients by dynamic

neuromodulation (2007); Using ARTHROFOON and SCENAR-therapy in multiple therapy of

purulent appendicular peritonitis patients (2008); Prolonged CCB and SCENAR-therapy in

hypertensive crisis at pre-hospital stage (2009).

2001 – organized the department on SCENAR clinical trials and biological research (RITM

OKB ZAO, Taganrog). In 2008 the department was reorganized into SCENAR-therapy Research

Institute. The research institute cooperates with the Institute of Biology (Southern Federal

University), Emergency Care Research Institute after I.I. Dzanilidze (Saint-Petersburg),

Volgograd Medical University, Niznii Novgorod Medical Academy, Moscow Regional Research

institute of the Clinical Medicine, Saint-Petersburg University after I.I. Pavlov and Medical

Academy of Postgraduate Education (MAPO, Saint-Petersburg), emergency hospitals and

stations in Rostov-on-Don, Bataisk, Taganrog, Azov, Pyatigorsk, Essentyki, Niznii Novgorod,

Saratov, Penza, Saint-Petersburg.

Author of more than 230 scientific publications, inventor of 5 devices, author and editor of

Guidelines on Emergency Care (in the amount of 40000 copies), author and co-author of 15

Guidelines.

Awards/Grants/Honors/Membership/etc.

Professor, MD.

Doctoral Thesis: Pharmacological regulation of body stress limiting antinociceptive systems in

the contex of psychounitropism, Moscow, 1994.

Member of the Testing Board of new drugs and devices of the all-Russian non-governmental

organization ‘Russian Community on Emergency Care’.

Member of the special-purpose committee on Emergency Care, Russian Ministry of Health.

Member of the all-Russian Association of the Emergency Doctors.

Member of the all-Russian Association on Pain Management.

Member of the editorial body in the Non-drug Medicine journal.

RESEARCH PUBLICATIONS:

A.V. Tarakanov, A.V. Ilyin, N.V. Kartasheva, L.V. Klimova, L.H. Musieva. The dependence of

the oxidative stress on the number of strokes in early postinfarction angina pectoris. Skoraya

Meditsinskaya Pomosch (Emergency) journal. – 2009. – № 2 – pp. 62-65.

A.V. Tarakanov, S.H.Luspikayan, N.P.Milyutina, A.V. Rozkov. The effect of ARTHROFOON

and SCENAR-therapy on characteristics of lipid peroxidation and antioxidant system of the

blood in postoperative therapy of purulent appendicular peritonitis patients. Experimental

biology and medicine bulletin. – 2009. – № 8 (Annex) – pp. 136-139.

A.V. Tarakanov, O. Kobilinsky. Modern diagnostic methods in evaluating physical efficiency of

smoke divers. Pozharnoe Delo (Fire-fighting) journal. – 2008. –№3 – pp.40-41.

A.V. Tarakanov, S.H.Luspikayan. Dynamics of lipid peroxidation in purulent appendicular

peritonitis patients. Issues of Biological, Medical and Pharmaceutical Chemistry journal. –

2008. – № 4 – pp. 32-36.

A.V. Tarakanov, E.G.Los, E.V. Hatisova. Using SCENAR-therapy for treating hypertension

crisis in prehospital period. Reflexology. – 2008, № 3-4. – pp. 23-26.

A.V. Tarakanov. SCENAR in therapy of chronic insomnia and neurocirculatory asthenia in

emergency doctors. Non-drug Medicine journal. Academic and research journal. №1 – 2007 –

pp.37-41.

A.V.Tarakanov. SCENAR and burn patients. Mechanism of action in terms of the functional

systems theory. Non-Drug Medicine journal – №4 – 2006 – pp.23-25.

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Yu.V. Yurova, A.V. Tarakanov. The effectiveness of SCENAR biofeedback transcutaneous

electroneurostimulator in treatment of burn patients. Skoraya Meditsinskaya Pomosch

(Emergency) journal. – 2006. – №3 (7) – p.138.

S.A. Kharitonov,A.V. Korolyov, A.V. Tarakanov. Modern therapies for burn wounds. Skoraya

Meditsinskaya Pomosch (Emergency) journal. – 2006. – №3 (7) – pp.133-134.

N.N. Usalyova, L.V. Klimova, A.V.Tarakanov. SCENAR-therapy effects on blood pressure and

state of the blood plasma oxidant-antioxidant system in patients with a compression wound

complicated by acute renal failure. Reflexology. – 2005. – № 3(7). – pp.37-42.

M.V. Ovsyannikov. N.P. Milyutina, J.Z. Grinberg, S.L. Maslovskiy, G.A. Tarakanova, A.V.

Tarakanov. Antioxidant and membrane protecting actions of SCENAR-therapy for opiomania.

Reflexology. – 2005. – № 3(7). – pp.15-18.

E.G. Los, A.V. Tarakanov. Multiple mechanism of SCENAR-analgesia. Reflexology. – 2005. –

№ 3(7). – pp.24-30.

A.V. Tarakanov, L.V. Klimova, N.N. Usalyova. The state of the blood plasma oxidant-

antioxidant system and blood erythrocytes in patients with a compression wound complicated by

acute renal failure at an anuretic stage. Anesthesiology and Critical Care Medicine journal. –

2004. – № 3. – pp.45-47.

A.V. Tarakanov, J.Z. Grinberg, N.P. Milyutina. Universal mechanisms of SCENAR-effect in

oxidative stress therapy. Reflexotherapy. – 2003. – №4 (7). – pp.41-45.

A.V. Tarakanov, A.D. Tatarchenko, N.V. Kartasheva, E.V. Kutovaya, O.A. Dmitrieva.

AMLODIPINE and MOXONIDINE in hypertensive crisis therapy in patients of old and senile

age. Skoraya Meditsinskaya Pomosch (Emergency) journal. – 2002. – V.3 – №2. – pp.49-50.

A.V. Tarakanov, E.E. Rastorguev. GLUTOXIM in therapy of diseases caused by Epstein-Barr

virus. Glutoxim. New ideology in complementing antibacterial, antiviral and anti-inflammatory

therapy. М., 2002. – pp.53-56.

A.V. Tarakanov, A.D. Belyaevsky, F.G. Sharshov. Actoprotector BEMITHYL: new horizons in

critical care medicine. Current issues of intensive therapy. – 2002. – № 1(10). – pp.59-64.

I.A. Dmitrienko, I.I. Morev, A.V. Tarakanov. ISRADIPINE in hypertension crisis therapy at pre-

hospital period. Emergency therapy. 2001. – №4-5. – pp.44-49.

A.V. Tarakanov, N.N. Domashenko, A.D. Tatarchenko, V.V. Horonko. MOXONIDINE

modulation (Cynt) of agmatinergic system – the aim of premedication at rachianesthesia.

Intensive Therapy News. – 2000. – № 5. – pp.104-108.

A.V. Tarakanov, I.V. Plotnikova, V.P. Galenko-Yaroshevsky, V.L. Popkov. The effect of

premedication on indices of local anaesthesia with LIDOCAINE and its combination with

CLOPHELINE at perineural administration in orthopaedics and traumatology. Kuban Scientific

Medical News. – 2000. – № 4. – pp.72-77.

I.V. Plotnikova, A.V.Tarakanov. Preventive use of CLOPHELINE for post-surgery analgesia in

abdominal surgery. Intensive Therapy News. – 1999. – №5-6. – pg.190.

A.V. Tarakanov, V.D. Shamhanyants. Premidication with MELIPRAMINE as рrееmptive

analgesia in gastrointestinal tract surgery . Intensive Therapy News. – 1999. – №5-6. – pg.195.

A.V. Tarakanov, Yu.S. Maklyakov, N.V. Nikitina, S.V. Kazakov, A.A. Nazaryan. Sublingual

use of ISRADIPINE (LOMIR) for managing hypertensive crisis in emergency conditions.

Therapeutic Records. Dep. 10.5.1998. – №D – 26029.

A.V. Tarakanov, D.P. Hlopinin, Yu.S. Maklyakov. The action of KETAMINE. Experimental

and Clinical Pharmacology. – 1996. – V.59. – № 6. – pp.56-61.

A.V. Tarakanov. Pharmacological use of CLOPHELINE in anesthesiology. Anesthesiology and

Critical Care Medicine. – 1991. – №6. – pp.71-75.

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A.V. Tarakanov. Neuropharmacological analysis and clinical course of anesthesia with

KETAMINE at central α2-adrenostimulation with CLOPHELINE. Anesthesiology and Critical

Care Medicine. – 1990. – № 3. – pp.23-26.

A.V. Tarakanov. Neuropharmacological analysis of anesthesia with KETAMINE at central

stimulation of α2-adrenoreceptors. – 1990. – V. 53. – №4. – pp.25-28.

N.N. Karkishchenko, A.V. Tarakanov. On effect of tricyclic antidepressants in central regulation

of hyperalgesia and stress analgesia. Experimental Biology and Medicine bulletin. – 1985. – №8.

– pp.193-197.

N.N. Karkishchenko, A.V. Tarakanov, N.A. Dimitriadi. On neuropharmacology of stress

analgesia. Pharmacology and Toxicology – 1983. – V.XLVI. № 2. – pp.20-24.

O.N. Kulikova, A.V. Tarakanov. The state of protein metabolism in patients with acute

myocardial infarction before and after pain syndrome management with FENTANYL and

DROPERIDOL. Pharmacology and Toxicology. – 1982. – № 4. – pp.52-54.

N.N. Karkishchenko, A.V.Tarakanov, N.A. Dimitriadi, V.V. Horonko. Studying

pharmacodynamics of neuroleptanalgetics interaction. Pharmacology and Toxicology. – 1982. –

V. XLV. № 3. – pp.45-50.

Copyright Certificates

A.V. Tarakanov, A. Sh. Grigoryan, A.D. Belyaevsky. Anesthetization technique. Inventions,

Breakthrough bulletin – 1990. – № 6. – pg.29. Copyright Certificate № 1560217.

N.N. Karkishchenko, A.V. Tarakanov, N.A. Dimitriadi. Anesthetic technique at managing pain

in myocardial infarction and surgery. Inventions, Breakthrough bulletin – 1983. – №40. – pg.23.

Copyright Certificate № 1050707.

Guidelines, Instructions, Books

A.V. Tarakanov, T.D. Tarakanova, A.A. Lebedenko. Using SCENAR-therapy in pediatric

practice. Part II. Allergic diseases. KMC ‘Copycenter’, Rostov-on-Don. – 2008. – 78 pgs.

A.V. Tarakanov. First and end points of energetic meridians. SCENAR-diagnostics and

treatment modalities. KMC ‘Copycenter’, Rostov-on-Don. – 2008. – 87 pgs.

A.V. Tarakanov, T.D. Tarakanova, A.A. Lebedenko. Using SCENAR-therapy and OLM healing

blankets in pediatric practice. Part I. Respiratory diseases. ENT pathologies. Taganrog,

‘Poznanie’ Publishing House, 2005 – 61 pgs.

A.V. Tarakanov. SCENAR-therapy and emergency. Part I. Pain relief. General points. Taganrog:

‘Poznanie’ Publishing House, 2005. – 94 pgs.

A.Ya. Cherchago. Recommended practice and guidelines on using RISTA-EPD hardware-

software complex in SCENAR-therapy. Taganrog: ‘Poznanie’ Publishing House, 2005. – 66 pgs.

A.V. Tarakanov, L.V. Klimova, V.I. Matvienko, M.S. Soboleva. Comas. Pre-admission medical

aid. Guidance manual, Block-type. Part I. General Approach to management of patients prior to

admission. Rostov-on-Don: 2004 – 103 pgs.

A.V. Tarakanov (gen.edit.). Guidelines for emergency doctors. Rostov-on-Don: Feniks

(Phoenix), 2002. – 514 pgs.

A.V. Tarakanov (gen.edit.). Guidelines for emergency doctors. Rostov-on-Don: Feniks

(Phoenix), 2001. – 480 pgs.

A.V. Tarakanov, V.V. Horonko, T.D. Tarakanova. Pocketbook for emergency doctor. Rostov-

on-Don, 1999. – 320 pgs.

N.N. Karkishchenko, Yu.S. Maklyakov, A.V. Tarakanov, L.G. Lebedeva. Ecological

pharmacology (Textbook). М., Izotekst. – 1990. Vol. 1. – pp.160-169, pp.201-219.

SCENAR B13.14

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ANNEX 3

Name: Cherchago Alexandr Yakovlevich


Tel.: (8634) 32-89-29, +7 905 450 7849


Web-site: http//www.scenar.com.ru

Date of Birth: November 9, 1953.

Director of department in RITM OKB ZAO, Candidate of Technical Sciences.

Education and work experience:

1976: Graduated from Taganrog State Radio Engineering University (since 2013 – Engineering

and Technology Academy, Southern Federal University) with a degree in ‘Automated control

systems’.

August of 1976 – September of 1980: worked in the applied Scientific Research Laboratory

‘System engineering’.

September of 1981 – 1983: combined post-graduate studies with work in RITM OKB ZAO.

1983 – 1987: full-time job in RITM OKB ZAO.

1987 – 1998: combined work for RITM OKB ZAO with teaching at the Engineering psychology

Department of the Taganrog State Radio Engineering University.

1987: passed Ph.D. defense.

1998 – Present: full-time job in RITM OKB ZAO.

Area of expertise:

Research and development of the hardware-software complex for the SCENAR-therapy

diagnostic support, mechanistic study of the SCENAR-therapy within and beyond the

physiological range.

Over 20 scientific publications (own and co-authored), including:

Patent for an invention № 2211660 ‘A device for the diagnostics of the patient’s body

according to the characteristics of the biologically active points’.

International Patent Application PCT/RU99/00456 ‘Diagnostic method for the patient’s

body condition according to the characteristics of the biologically active points and a device for

the diagnostic procedure’.

Guidelines for the use of the hardware-software complex ‘RISTA-EPD’ in SCENAR-

therapy.

At present Cherchago A.Y. is the Director of the research department in RITM OKB ZAO.

SCENAR B13.14

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ANNEX 4

Name: Molchanov Artyom Yuryevich



Date and Place of Birth: 1981, Leninsk, Kzyl-Orda region, the Republic of Kazakhstan

Education work experience:

2004: Graduated from Taganrog State Radio Engineering University with a degree in ‘Basics of

information and computer science’.

2004-2006: pursued postgraduate studies of Taganrog State Radio Engineering University.

2006: passed Ph.D. defense.

Since 2007: associate professor in chair of ACS (Automatic Control Systems).

2004 – December of 2012: coordinated work in the University with the position in RITM OKB ZAO.

2013 – present: leading engineer, full-time job in RITM OKB ZAO.

Area of expertise:

Medical diagnostic systems. Optimization of the engineering systems with the Artificial

Intelligence and fuzzy logic application. Artificial intelligence systems. Mathematical modeling

in engineering and biological systems.

Over 30 scientific publications (own and co-authored), including:

1. Molchanov А.Y., Finaev V.I. Interface options of the HL7 application protocol.

Proceedings of the VIIIth International Scientific and Technical Conference of Students and

Post-graduate Students ‘Radio electronics, electrical engineering and power engineering’. In 2

volumes. 1st volume. – М.: MPEI publishing office, 2002, p.308-309.

2. Molchanov А.Y., Finaev V.I. The standardization of the construction of an automized

information support system for the medical research. // Abstracts of the National Scientific and

Technical Conference of students, young scientists and specialists ‘New information

technologies in science and education’. – Ryazan: RGRTA, 2001, p.77-78.

3. Molchanov А.Y., Finaev V.I. An automized information support system for the

medical enterprises. // Proceedings of the National (with international participation) Youth

Scientific Conference ‘The XIth Tupolev readings’. – Kazan: KSTU, 2003, v.3 p. 76.

4. Molchanov А.Y. An automized information support system for the medical enterprises

// Proceedings of the XVIth National Scientific and Technical Conference of students, young

scientists and specialists ‘Bioengineering, medical, and environmental systems and complexes’,

Ryazan: RGRTA, 2003, p.96.

mailto:[email protected]

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