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SCENAR B13.14
Issue 14 of 19-07-2019 Page 1 of 51
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
SCENAR B13.14
Issue 14 of 19-07-2019 Page 2 of 51
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
SCENAR B13.14
Issue 14 of 19-07-2019 Page 3 of 51
Device name Type/model/version Trade (alternative) names
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.
SCENAR B13.14
Issue 14 of 19-07-2019 Page 4 of 51
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
SCENAR B13.14
Issue 14 of 19-07-2019 Page 5 of 51
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.
SCENAR B13.14
Issue 14 of 19-07-2019 Page 6 of 51
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.
SCENAR B13.14
Issue 14 of 19-07-2019 Page 7 of 51
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.
SCENAR B13.14
Issue 14 of 19-07-2019 Page 8 of 51
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
SCENAR B13.14
Issue 14 of 19-07-2019 Page 9 of 51
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
# Title, Author, Publication
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
SCENAR B13.14
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# Title, Author, Publication
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
SCENAR B13.14
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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.
Evidence grade: Ib/1/B/P
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.
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.
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 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.
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
Efficacy of SCENAR Therapy for Myofascial Pain Syndrome
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.
Evidence grade: III/4/D/P
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.
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.
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.
Evidence grade: Ib/1/B/P
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.
Evidence grade: Ib/1/D/P
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.
Evidence grade: IIb/2/D/P
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.
Evidence grade: III/4/D/P
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.
Evidence grade: IIb/2/D/P
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.
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.
Evidence grade: IIb/2/D/P
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).
Evidence grade: IIb/2/D/P
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.
Evidence grade: IIb/2/D/P
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.
Evidence grade: III/4/D/P
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].
Evidence grade: IIb/2/D/P
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.
Evidence grade: Ib/1/D/P
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.
Evidence grade: III/4/D/P
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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.
Evidence grade: IIb/2/D/P
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.
Evidence grade: IIb/2/D/P
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.
Evidence grade: IIb/2/D/P
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.
Evidence grade: IIb/2/D/P
Uncomplicated hypertensive crises [B9]
Overall 97 patients were treated by SCENAR therapy in one study on uncomplicated
hypertensive crises at pre-hospital stage.
SCENAR-therapy was considered as an effective and safe therapeutic method for cases of
uncomplicated hypertensive crises in pre-hospital period.
Evidence grade: III/4/D/P
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.
Evidence grade: Ib/1/D/P
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.
Evidence grade: Ib/1/B/P
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.
Evidence grade: III/4/D/P
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.
Evidence grade: Ib/1/B/P
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.
SCENAR B13.14
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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.
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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
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
SCENAR-1-NT (version 02.2C) RITMSCENAR Pro Optima C
SCENAR Pro Optima C
SCENAR Physio
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Device name Type/model/version Trade (alternative) names
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.
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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
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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
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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.
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.
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.
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.
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 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.
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
Efficacy of SCENAR Therapy for Myofascial Pain Syndrome
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.
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.
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.
Evidence grade: IIb/2/D/P
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.
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.
Evidence grade: Ib/1/D/P
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.
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.
Evidence grade: IIb/2/D/P
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.
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.
Evidence grade: III/4/D/P
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.
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.
Evidence grade: IIb/2/D/P
6) 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.
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.
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.
Evidence grade: IIb/2/D/P
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).
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.
Evidence grade: IIb/2/D/P
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.
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.
Evidence grade: IIb/2/D/P
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.
SCENAR-therapy was considered as an effective and safe therapeutic method for cases of
uncomplicated hypertensive crises in pre-hospital period.
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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.
Evidence grade: III/4/D/P
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.
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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
# Authors, Title, Publication
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
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
[not a clinical study]
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
[no information available]
CLINICALTRIALS.GOV
Link: https://clinicaltrials.gov/
Date: 01/02/19
Keywords (Other Terms): SCENAR
Table 4
# Authors, Title, Publication
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
# Authors, Title, Publication
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
[no information available]
3 Effect of artrofoon and SCENAR therapy on parameters of LPO and antioxidant system of
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
# Authors, Title, Publication
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
[no information available]
5 Prinz, Jorg. (2014). SCENAR for Pain Relief and Chronic Illness. The New Zealand
Journal of Natural Medicine. 2014. Issue 13. p. 26-27
[not a clinical study]
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
[not a clinical study]
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
[no information available]
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
SCENAR B13.14
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Table 7
# Authors, Title, Publication
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
# Authors, Title, Publication
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.
[not a clinical study]
#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
[not a clinical study]
#82
19 Boris Zaidiner, Ilia Baranovsky, Nicolay Lyan
One Biophysical Option in Fatigue
Support Care Cancer (2005) 13: 401–483
[not a clinical study]
#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
[not a clinical study]
21 Jakov Grinberg
Physical influencing factors in SCENAR-therapy. Application sound therapy
[not a clinical study]
#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
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
Collection of Articles
[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
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
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
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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.
[not a clinical study]
#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
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
Collection of Articles
[outcomes]
#53
36 V.N. Sokurenko, R.N. Chuprina, S.P. Goncharova
SCENAR-THERAPY IN TREATING STERILITY
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
Collection of Articles.
[outcomes]
#54
37 S.V. Moiseev
SCENAR-Technology and Sports Medicine
[not a clinical study]
#34
38 Grinberg Y.
SCENAR-Therapy And SCENAR-Diagnostics
[not a clinical study]
#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
[not a clinical study]
#35
44 J.A. Petrov, S.I. Petrova, V.V. Bakaras
TREATING LACTATIONAL MASTITIS WITH SCENAR-THERAPY
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
Collection of Articles.
#55
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[study design]
45 Boris Kulizhskiy, O.V.Minaev
The Analysis of Peripheral Blood Changes Following SCENAR-Treatment
[not a clinical study]
#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
SCENAR-therapy and SCENAR-expertise. Issue 9-10, Taganrog, 2004.
Collection of Articles
[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.
[not a clinical study]
#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
[not a clinical study]
#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
E-mail: [email protected]
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.
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ANNEX 3
Name: Cherchago Alexandr Yakovlevich
Business address: 99 Petrovskaya Street, Taganrog 347900, Russian Federation
Tel.: (8634) 32-89-29, +7 905 450 7849
E-mail: [email protected]
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
Business address: 99 Petrovskaya Street, Taganrog 347900, Russian Federation
E-mail: [email protected]
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.