CLINICAL TRIALS

 

« PHARMACOLOGICAL ECONOMIC STUDY  SOCIETY» 

INTER-REGIONAL PUBLIC ORGANIZATION(IRPO)

 

 


REPORT

 

 

 


ALMAG-01 DEVICE  APPLICATION EFFICIENСУ

 CLINICAL ECONOMIC ANALYSIS FOR  PATIENTS  THERAPY                         WITH GONARTHROSIS DISEASE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Moscow, 2011

 

Report objective:

ALMAG-01 device  application  efficiency  clinical economic analysis for gonarthrosis disease therapy  

Research manager:

Pavel  Andreevich Vorobjev -  President of (IRPO)« Pharmacological  Economic  Study Society», Doctor of Medicine, Professor 

Executors:

Oleg Vasiljevitch Borisenko -   (IRPO)« Pharmacological  Economic  Study Society» Chief executive director, Candidate of Medicine;

Irina Valerjevna Telegina - (IRPO)« Pharmacological  Economic  Study Society» researcher;

Ludmila Yurjevna Bezmelnitsyna - (IRPO)« Pharmacological  Economic  Study Society» researcher;

Madlena Yurjevna  Hersesjan - Russian State Medical University named after I.M.Sechenov public health services department  medical aid and medicine problem quality control laboratory leading engineer.

 

 

 

 

 

 

 

 

 

 

 

 

Summary

Prospective, controllable, randomized, double - blind examination  with  Almag-01device use has been  carried out  for magneto-therapy efficiency study. All patients have been divided  into 2 groups: in the basic group there was used  the working device Almag-01, in control one  - placebo  device  in appearance and design  looking like the working device.

Both Almag-01 device and placebo  device have been applied according  to   application manual, the course  treatment included 18 procedures.     In examination there was allowed the combination of physiotherapeutic and medicamentous treatment  in  accordance with  the standard practice. All prescribed  medical   procedures   and medical preparations have been  recorded   in the patient  medical  individual card  To make  therapy efficiency  estimation there were used criterions  as  follows: functional abnormalities intensity ( under International Classifier  ), and also changes of  life quality value  ( to study life quality value questionnaire EQ-5D was used). Besides there was used ALMAG-01 device application efficiency   clinical economic analysis  according to “ expenditures – advantages  ”  criterion.   

The total number of patients  involved into examination was  170 ( 75  (44,1 %) of them applied  ALMAG-01 the working variant, 95 ( 55,9 %) -  ALMAG-01 device placebo variant).  To the  moment  of examination beginning   the groups haven`t been  comparable: the patient in  ALMAG-01 placebo- device group , had the worse  characteristics both of  articulation  function  ( according to objective parameters and International Classifier  indexes  ) and life quality  values ( except life quality value being  evaluated according to visual- analogous scale).

According to examination results, the life quality dynamic evaluated according to visual- analogous scale in ALMAG-01 device group  came to 0,11 points; in placebo – device group -  0,1 points. While studying life quality being evaluated according to  ED-5D  questionnaire 5 indexes, in both groups there was noted   statistically  considerable  reduction of patients number with  life quality moderate or severe   abnormalities according to  ED-5D  questionnaire  all 5 indexes except self-service factor in ALMAG-01 device group.

  And at the same time in placebo – device group as compared  with ALMAG-01 device group  there was noted much more considerable reduction of patient number having  life quality moderate or severe   abnormalities  ( except pain and discomfort value index ) according to  : space movement index -   29,4% and  26,7%  accordingly; self-service index -   26,3% and 1,3% accordingly; daily activity index - 52% and 33,3% accordingly) ; pain and discomfort index 37,9% and  57,3% accordingly; worry and depression  index - 43,2% and  30,6% accordingly.  So Almag-01 device as compared   to placebo – device   had more expressed effect to  life quality value concerned with pain and discomfort.

Making joints` function characteristics evaluation according to function abnormalities International scale there were not revealed   statistically significant    value differences between groups but  however there was noted  more positive dynamic of joints` mobility function values in Almag-01 device group as compared with placebo – device group    (21,3% and  9,5% accordingly). Inside  Almag-01 device group there were  not noted  “ Walking and moving” indexes  statistically significant changes according to  function abnormalities International scale. As for  placebo – device group there  were no noted  any statistically significant changes according to  short-distance walking index.

  At the same time in the placebo – device group there was noted statically significant reduction of the patients number with  severe and mean  abnormalities  according to 1 km   walking distances ( from 69,4 % up to 46,3 %) and increase of  a number of  the patients with slight  abnormalities according  to this value index (from 10,5 % up to 31,6 %).  In Almag-01 patients group as well  there were evidently  revealed  a greater number of the patients having slight  abnormalities  or their absence  according to  «short distances walking » value   as being compared  with  placebo - device patients group (14,6 % and 4,2 % accordingly).  

The total costs  for  one patient treatment in  Almag-01 device   group came  to  7648,04 roubles. The total costs for one  patient treatment in  the placebo-device group came to  9 604,12 roubles.

Magneto-therapy with a help of ALMAG-01 device clinical-ecomonic analysis turned out to be an effective policy decision from the position of expenses at carrying   “ expenses – efficiency” analysis  out  according to  life quality value severe and mean  abnormalities  dynamic criterion in relation with  pain and discomfort. So  it required to spend 13 417 rub. in order to reduce life quality  severe and mean  abnormalities  per patient in ALMAG-01 device group that is practically twice less   as compared with the expenses in placebo-device group  for achieving the same goal ( 25 956 rub. per patient).

       Thus, the performed prospective, randomize, double blind, controllable magnetotherapy efficiency study with    Almag-01 device has shown, that the device  has an effect on patients revealing itself in   pain and discomfort  decrease, however as for the  other values (parameters)  there were no   differences in  its  efficiency evaluation.  

 

 

 STUDY URGENCY

At present оsteoarthrosis   takes  leading position in the world mong joints degenerate diseases, and  for their  prevalence - the first place among rheumatic illnesses,  being  only after  bone and joint illnesses  and  back pain syndrome.

Osteoarthrosis represents itself  a serious medical and social problem, it often has  chronical clinical picture  and   results in patients disability. This is frequent  and   important course of  elderly people joints pain and reduction of their physical  activity. Disease clinical course is joints pain and reduction of elderly people physical activity.  Osteoarthrosis сlinical appearance  as a rule, begins at the age of more than 40-45 years , radiological characteristics of  osteoarthrosis are defined  at 50 % of  population at the age of 55 years and  80 % -at the age more than 75 years.  

 

В настоящее время это заболевание уже не считается простым следствием старения и дегенерации хряща, как ранее [13, 14, 15]. At present this disease is not considered simply as a result of cartilage both  aging and degeneration as it was early  but  in its basis there is active processes both of degenerative-destructive and reparative character. Hyaline cartilage, ubchondral bone, synovial membrane, intraarticular ligament, articular capsule, paraarticular muscles and          tendons are involved into  pathological process. Last year it is noted that there is inflammatory process in the basis of osteoarthrosis as well as other rheumatologic  diseases with  injury of  articular apparatus.

Complexity of physiotherapeutic treatment application is that  the age  inevitable consequence is polymorbidity , that  is often an essential restriction for  preformed  physical therapy  administaration  (the problem of especially  actual is   cardiovascular pathology ).

 One of the methods of  physiotherapeutic treatment widely recommended even at presence of concomitant diseases is  magnetic field exposure on an  human organism. АЛМАГ-01 is  magneto-therapy  device indicated for organism  local exposure with a help of traveling pulsed magnetic field . Study of  magnetotherapy with  the help of Almag-01device  indicated for knee joints osteoarthrosis  treatment is also presents  interest.

Work objective:  osteoarthrosis therapy with ALMAG-01 device  clinical -economic analysis

Examination tasks :

·        To carry out analysis of the literature on magnetotherapy application (in particular, device Almag-01) efficiency and safety for osteoarthrosis disease treatment.

·        To choose criteria for magnetotherapy efficiency evaluation   and draw up test  report

·        To carry out clinical examination  of  Almag-01 device  application efficiency and safety  according to test report

·        To calculate direct medical expenses for both Almag-01device physiotherapy  and comparison therapy.

·              To carry-out  ALMAG-01 device  clinical-economic analysis.

 

Magnetic field is specific type of material providing connection and interaction between traveling electric charges. Magnetic field is being generated wherever there is traveling electric charge or current. It can exist both in material medium and in vacuum. Unlike the electric field the magnetic field  can only produce effect  on traveling  charges  and only through it external magnetic fields it can effect the particles.   This is due to the fact that only traveling charges  have their own magnetic field  Its important particular feature is its unlimited extension in space: though  when moving away from traveling charges the field becomes considerably weaker but  has  no  limiting boundaries.

Classification of magnetic field.

·        According to its origination: natural ( Earth`s and Sun`s geomagnetic fields,  magnet fields), artificial fields, magnetic field of  bio-objects.     

·        According to their alteration in time: permanent magnetic field, alternating magnetic field, pulsed magnetic field, pulsating magnetic field and noise -type  magnetic field 

·        According to their modification in space: uniform and non-uniform fields.

·        According to their intensity: weak, mean, strong and super-strong.

Permanent magnetic fields  do not  change at  a particular point either in time or in direction.  It  is  induced by both direct current inductors and  hard and flexible magnets.

Alternating magnetic field changes in time relative to   its value and direction . It is generated  by inductors powered with alternating  electric current; Sinusoidal magnetic field is a particular case of alternating magnetic field.  It is  generated  by  industrial alternating current or special sinusoidal  oscillations  generator. 

Pulsed magnetic field is changes in time relative to  its  value but does not  change in direction. It is generated by the pulsating current inductors.

  Pulsed traveling magnetic field is a  field traveling in space  relative to   motionless patient and  pulse -changing  in time.  

Pulsed traveling magnetic field  possesses the greatest number of biotropic  parameters and is characterized by the greatest magneto-biological activity

Magnetic field is represented graphically as a  system of lines called as  magnetic flux lines. They present themselves imaginary closed magnetic lines drawn so that   tangents to them  indicates the direction of field vectors or  magnetic induction vectors at any point in the field. Line density correlates with  the numerical values of corresponding quantities.

The direction from the North to the  South Pole is  conventionally taken as the  direction of a magnetic field vectors in the environment and in permanent magnets.

.The term” biotropic parameters” means physcical characteristics of a magnetic field determining  primary physio-chemical and informative  mechanisms of the  field  effect causing the formation of corresponding reactions both of  individual organs and the organism as a whole.( M.A. Shishlo). The term” biotropic parameters”  include:   the type of the field, its induction,  energy, gradient, vector and frequency. Form of the field in time and space, effect  exposition and localization.  Particular disease therapeutic efficiency is significantly  depend on each of these parameters as well as on their combination.

Induction (В) is magnetic field basic feature. It is  magnetic  flux density in the area confined by closed conductive contour. The unit of its measurement is tesla (Tl.) and millitesla  (1mTl = 10‾³Tl) in physiotherapy. 1 mTl induction magnetic field causes tissue threshold changes providing initial  therapeutic effect. That is why the distance from  the source within which  induction value  comes to 1 mTl. is defined as  this particular source magnetic field  “ penetrating effect  depth”.

Frequency is  magnetic field another important biotropic parameter.    Yu.A. Kholodov and M.A.t Shishlo (1979) researchers revealed hat electromagnetic fields   with α – rhythm frequency of  human ECG (8-14 Hz) causes greater effect than adjacent frequencies of similar intensity.                     

 Magnetic field gradient is the value of magnetic induction  which changes  with 1cm. distance change away  from the source. It shows the direction of magnetic induction value change at a particular vertical and  horizontal distance.  

Field intensity is the strength  a magnetic field effects rectilineal  conductor  located perpendicularly to the direction of field lines with current intensity of 1  unit.  The  vector shows  the direction of magnetic power lines and with its change  there is   the change of its  biological effect  character.

Therapeutic effect depends on a field pulse shape. According to  Yu.A. Kholodov (1987), pulse rectangular form possesses greater  activity compared to  a sinusoidal one.  

Exposure time is of a similar significance. Traditionally defined procedure  duration is in the range of 10-30 minutes daily procedures with procedure course  from 5 to 25 days. Further studies  should be undertaken taking into consideration patient`s age, individual features, magnetosensitivity as well as pathological form, stage and   severity.        

Local magnetic exposure is defined , as  usual,  by pathological area  added   with the effect on Zakharyin-Ged`s reflex zones and biologically active points. It is well known that there are two types of magnetotherapeutic exposure: local ( to pathologic focus) and  general  ( to the patient`s body as a whole)Being quite different these two types should not be considered as completely  dissimilar since  any local exposure inevitably initiates reflex  mechanisms stimulating the response of central control mechanisms (though this response would be undoubtedly weaker compared to a general exposure) Thus, local magnetic exposure effects a concrete anatomical area making the devices for  local magnetotherapy more efficient and convenient.

 

Biophysical and biochemical bases of magneto-therapy

Under the effect of magnetic fields in  macromolecules ( enzymes, nucleic acids, proteins etc.) there are  both generation of charges and  the change  of their  magnetic    susceptibility. Macromolecules magnetic field energy can  exceed the energy of  thermal movement, thus even therapeutic doses  of  magnetic fields cause orientation and concentration changes of biologically active  macromolecules resulting in kinetics of biochemical reactions and biophysical processes speed.

In magnetic field primary effect the great importance is given to liquid crystal oriental rebuilding making the basis of cell membrane and many intracellular structures. Liquid crystal ( membranes, mitochondrion) orientation and deformation under magnetic  field  effect  manifests itself on their permeability  playing  important role in the regulation of  biochemical  processes and the  performance of their biological function.     

Magnetic field effect on elementary currents in atoms and molecules of intra-and- extra-cellular water results in  its quasi-crystal  structure change. Due to  specific  spatial orientation of elementary currents  in atoms and  molecules there is change of   water properties:surface tension, viscosity, conductivity, dielectric  permeability etc.    This promotes the molecules of proteins, nucleic acids, polysaccharides and other macromolecules to  perform their specific functions; they  form a common system with water and their transport and metabolism dependent on the water-bonded state . 

One of the important regulatory mechanisms  in living systems is ion activity. It is primarily determined by their  hydration and connection with macromolecules.  Under the effect of magnetic field system components differ in the magnetic and electronic properties  ( ion-water, protein-ion, protein-ion-water) there would be  oscillatory motions with the parameters that might not coincide.  As a result  there will be both ions release out of macromolecules connection and decrease of  their hydration thus promoting ion activity. This  ion activity increase under the  magnetic field effect is considered as a precondition for cell  metabolism stimulation.     

With a magnetic effect on the vessels not only biologically active  macromolecules but also super-molecular and cellular  structures would be oriented. Erythrocyte alignment under the effect of magnetic fields  is a marked manifistation of such orientation.   The less diameter of the vessel, the weaker magnetodynamic effect is.  Among other macroscopic effects of   magnetic fields, their ponderomotor influence on  nerve trunks and muscular fibers should be mentioned. The result of which is  their electro-physical activity and functional behavior change.  

Specific effect of alternating and  paramagnetic interaction are of special attention. In addition to  diamagnetic and paramagnetic interaction  there is interaction with ac current in casae of any magnetic field alteration.. Since in tissues there are charges, ions and  electrons the induced electric field would cause their motion, i.e. would generate electric current possessing manifold biological effect.     

Taking the above  mechanisms into  consideration  it can be stated that  a permanent magnetic field effects the body  through dia-and-paramagnetic effects while alternating and pulsed  field produce an  additional effect through generated electrical currents. When effecting the living systems, submolecular, molecular and supramolecular structures  become  activated resulting in cellular, systemic and body level changes.

 

The mechanism of physiologic and therapeutic effect

The magnetic field  effect on  human body is characterized by:

·        individual sensitivity and unstable response of the body and  its systems  to magnetic field exposure;

·        correcting magnetic field effect on the body and its functional systems resulting in  normalization of hyper-and-hypofunctioning organs and systems. Effect on the background of organs or system   hyperactivity   results in its  decrease and the application of the magnetic field in the conditions of its function  depression is followed by its  increase;  

·        the change of  body response phase direction  to the opposite one  under the magnetic field effect ;

·        therapeutic efficiency degree dependent on magnetic field characteristics. The  effect is more evident  in case of alternating and pulsed magnetic  field exposure compared to  a permanent one;

·        a great number of  body responses are of a liminal or resonance character, particularly, when pulsed magnetic fields are applied;

·        trace character of magnetic field exposure. After a  magnetic field single exposure body response lasts for 1-6 days, while the course of procedures is followed by 30-45 days` response this fact  sets conditions for  making   an interval between  repeated procedure courses.     

The response of various organs and systems to magnetic field is not similar. Selectivity of body  response depends on electrical and magnetic behavior of tissues, the difference in their micro-circulation, metabolism intensity and the state of  neuro-humoral circulation.  Sensitivity of nervous system to magnetic field  exposure puts it in the first place among the others; then goes endocrine system which is followed by sense organs, cardiovascular system, blood, muscular, digestive, excretory, respiratory and bone systems.    

 Magnetic field short-term exposure has various effect to organism promoting   the development of  individual  favourable reversible processes. The most evident  and more important for disease clinical picture is sedative, hypotensive,  anti-inflammatory, anti-edematous, analgetic and  trophicoregenarative action. Under  certain conditions e.g. when exposing large vessels,  magnetotherapy produces  deaggregation and hypocoagulation effect, improves micro-and-regional circulation, effects favorably on immunorealtive and neurovegetative  processes.      

Magnetic exposure as a rule  neither generate endogenic heat not  causes  temperature rise or skin irritation. It is well tolerated by weak and elderly patients suffering from concomitant cardiovascular diseases. This fact allows   to apply  the device when  the other physical procedures are not indicated.        

Despite of their beneficial effect magnetic fields with the intensity over 70 mTl  can become  stress agents acting  unfavorably on various functional systems resulting  in discoordination of endocrene activity; decrease of energy processes intensity;  glycolysis activation; disturbance of cellular membrane permeability;  development  of hypoxia and dystrophy processes. Taking these factors into account it should be   noted the necessity of safety measures and dosage control strict observation.     

ALMAG-01  magneto-therapeutic device is designed for  local effect on the human body with a traveling  pulsed magnetic field.   

It presents itself a flexible four inductor unit of 0.5 m  total length  which is placed on the human body affected  area. The weight of the device with the power supply unit is not more than 0.55 kg. The penetration  depth of a magnetic field   into  patient`s body in therapeutic doses  is 6-8 cm. which  allows direct  exposure  both  the surface pathalogical  focus and inner organs.

The device action  is characterized  by its high  biological activity  due to  the  greatest nummber of biotropic parameters of  generated  travelling pulsed magnetic  field. Patient`s adaptation to the device electromagnetic action   has  not been noted.    

Electromagnetic pulse repetition rate (6.25 Hz).Total duration of an operating  cycle is set  with a timer.

Though the ALMAG-01 has two operating surfaces its inductor is designed so that 15 cm distance away from it its magnetic induction is comparable with  the common  Earth background ( 0,05mTl), so there is no  “ magnetization” of     surrounding objects that is of gear significance for the personnel of physio-therapeutic rooms.   

Patients noted good tolerance of conducted procedures. Almag-01 device application assessment general clinical efficacy showed that 79% of patients  had  reduction of clinical   signs  and the improvement of patients` general condition  and  only 21%  of patients had only slight improvement of their condition. There was no   noted a case of patients` progressive deterioration. ( Maligin and co-authorship).      

When studying  the state of vegetative nervous system, neuroendocrine regulation and central nervous systemactivity   during device ALMAG-01 therapeutic exposure  on  patients  organism   on the hardware-software complex intended for the analysis of biological rhythms of person organism  allocated from electrocardiosignal in a wide  frequency  band it was  marked,  that  the functional conditions parameters of patients  suffering  from acute  and chronic diseases  showed   dynamics drastic increase ( growth) up to the treatment 6th day and later on smooth, stable and  simultaneous increase. This is the evidence of all organs and systems function  harmonic  change as a result of ALMAG-01 device course treatment  and the proof      of its application expediency for the above said disease groups. 

At the same time, randomized study  with use of  device ALMAG-01 it had not been  carried out.

 

MATERIALS AND METHODS

Method of study : prospective, controllable, randomized, double - blind. All patients were  divided into 2 groups: working Almag-01device was applied  in the basic group ,while  in the control one  - the placebo device which did not differ from the working ALMAG-01 device in  appearance and  design. The only  difference between them  was the absence of contact between the generator and electromagnetic radiation effector (unit body).

The period of study duration  -  21 days.

Object under study  - patients suffering from gonarthrosis, taking  treatment in a hospital.

The number of patients involved  in medical examination in each medical center is 20-40. The patient`s card have been drawn up for each patient. Partient`s cards included the data both on medical expense, procedure tolerance and efficiency. The treatment of the patients  of  the main group has been carried out with  the use of ALMAG-01 device, in the control group  placebo-device was used. Magneto-therapy has been  carried  out  in accordance with operating manual for the device  taking into account existing clinical experience.

Before examination  there were  carried out  both  medical centers initial randomization  and patients randomization in the clinical center; besides there were prepared  6  device-sets  included ALMAG-01 working devices and ALMAG -01 placebo-devices. All devices in the sets have been marked with  figure  «1» and «2» The device numeration  was known only by  medical center employees.  Beforehand there were prepared the required number of envelops marked with figures  «1» and  «2» adequate  to the number of patients  («1» - working device and  «2»- placebo device).  Unawareness of patients and doctors of the  placebo device real nature was reached   by using specially manufactured placebo devices ( devices not generating  magnetic field)  which were not differ  from the ALMAG-01  working device    and  placed in the same physiotherapy room. In medical  center, after selection patients` group  in accordance with  appropriate  criteria , the doctor opened an envelope   where  number of the device had been identified

Criteria to the patients  to be included into groups for medical examination :

· men and women of 18 years old and elder

· the patients suffering from gonarthrosis and/or coxarthrosis, except   their  severity conditions ( the patients have been diagnosed on the basis of  clinical criteria ( given below) and in compliance with existing clinical practice.                                       Gonarthrosis  clinical criteria : (sensitivity-  89 %, specificity - 88 %) [V.V.Tsurko, 2004]:       

§ Pain + crepitation + morning constraint less than 30 minutes + age- more than 38 years old or

§ Pain + morning constraint less than 30 minutes+ joint size expansion  

§ Pain +  joint size expansion.

o   Coxarthrosis   clinical criteria : (sensitivity-  91 %, specificity - 89 %) [V.V.Tsurko, 2004]:

§ Pain + osteophyte or

§ Pain  + ESR less than  20 mm/h +  joint cartilage space  constriction

·        Absence of severe or unstable somatic, neurologic or mental diseases which can prevent the examination

·          Presence of the patient consent to  participation in examination

Medical examination contraindications:

·        the age below 18 year old,

·        osteoarthrosis  severity,

·        Presence of absolute and relative indications to Almag-01device application

                        - acute inflammatory diseases ,

          - bleeding ( hemorrhage)  and susceptibility  to it

                         - high-grade hypotonia,

                         - purulent processes before surgical operation ,

                         - heart ischemic disease severe stage ,

                         - early postinfarction period ,

                         - stroke

                         - pregnancy,

                         - blood systemic disease ,

                         - oncological diseases

                         - thyrotoxicosis,

                         - diencephalic syndrome,

                         - presence implanted cardiostimulator in a zone of influence.

Almag-01working device  and   Almag-01 placebo  devices were used according to application instruction: course of treatment included  18 procedures, with a  day break  after 6-th and 12-th procedures depending on organism reaction; procedure time for the first 3 procedures was 10 minutes, with the increase of  its  further duration by 2 minutes per procedure and up  to the 8th procedure the procedure  time came to 20 minutes, and further on duration of each procedure was 20 minutes; in case of  disease aggravation to  3th -4 th treatment day,   procedure time was  reduced  by  1/4; procedures were carried out  once a day.

.In examination ,according to the standard practice,  the the combination of physiotherapeutic treatment with medicamentous treatment was used.

All medical preparations  were put down  into patient individual card.

Examination  process.

Patient informed consent to take part in examination: before examination it is necessary to get patient`s consent to involve him/her into  examination .

During randomization  each patient was  given individual identification  number one for all examination period .

It is supposed that  patient should see doctor -physiotherapist twice:

·          the first visit – when he/she was included into examination list ;

·          the second one  – 20-24 th day after the  examination beginning . 

During  his/her  first visit to the doctor the patient signed the informed consent on his/her participation in examination.  If the patient`s state of health met the required criteria, doctor  filled in examination card appropriate section concerning   patient  demographic data,  state of health before being involved in the process of examination, prescribed   both diagnostic procedures, their results and medical preparation the patient took before examination, gave the assessment of  patient functional  disorders and magneto-sensitivity. The patient filled in questionnaire EQ-5D.

Magneto-sensitivity was measured as follows: at first ABP was measured;  then  there was conducted heels electromagnetic exposure  for 5 minutes; after that ABP was measured again.   Magneto-sensitivity was considered as low if   ABP   hadn`t been  changed ; as mean -  if ABP (  systolic and diastolic ) had 5-10 mm.Hg change , high - if ABP had changed more than  10 mm. Hg.   

During the second visit, the treatment tolerance was evaluated . If the result of the  evaluation  was satisfactory the treatment was kept on.   

During the patient  third visit to the doctor ( 20-24th  examination day or  the day of discharge from hospital) the  information of all  medical services and medical preparations taken by the patient during the  medical examination period, the number of laboratory  examinations, the availability of side effects , change of therapy scheme were  being put down the  patient card.  After medical examination termination the doctor  made reassessment of the  degree of the patient  functional disorders.  And  the patient filled in questionnaire EQ-5D again.   

The following criteria were used for therapy efficiency assessment: intensity of functional disorders  (according to  Functional Disorders  International Classification) , and also the change of  life quality parameters  ( questionnaire EQ-5D was used to study life quality ).

 Assessment of functional disorders has been carried out according to   on Functional Disorders  International Classification 5 points  scale: 1 point - “ no any disorders”, 2 points - “ low-grade  disorders”, 3 points  - “ mean-grade disorders”, 4 points      - «evident disorder ”, 5 points  -”absolute disorders”

There were used 6 scales :

·        «some joints mobility»,

·        « joints total mobility»,

·        «some joints stability »,

·        «joints total stability»,

·        «short- distance walk»,

·        «long- distance walk».

The choice of scales was stipulated  by  concrete  illness  symptomatology.

Estimation of safety: presence of by-effects and presence of cause -and -effect interrelations according to Naranzho scale was estimated.

The termination of medical examination : examination was stopped on the expiration of 18 magnetotherapy procedures, or at the appearance of by-effect presenting in opinion of the doctor the hazard  to the patient relating to  the application of the device, or patient refusal to take part  in  examination .

 

ECONOMOC ASSESSMENT  

Within the examination process the  information on all treatment -and- diagnostic procedures and medical preparations taken by patient  have been put down into  examination card. Direct medical expenses have been estimated.      

PRICE INFORMATION

Medical procedure costs have been calculated according to   Затраты на услуги рассчитывалась по формуле (1):

 

                  У = С х Ч х К, (1)

Where :

У –  rendered medical service cost ,

С – medical service price under per medical service  tariff ,

Ч – rendered medical service ferequency ,

К – rendered medical service ratio.

Medicinal preparation  avarage prices   have been taken on  information site  “ PHARM -index”  (www.pharmindex.ru) (24.12.2010). 

 Hospital accommodations expenses were calculated as hospital  avarage stay  duration multiplication    by per  bed-day artrology hospital treatment price ( 176,17 rub). 

 Per patient total costs in both  Almag-01  working device group and Almag-01 placebo device group   were calculated according to formular  (2):

C = Cm + Cs + Cг,

where :

C  - per patient total cost  ,

Cm – medicinal preparation costs per patient ,

Cs – medical service expences per patient ,

Ca – hospital accommodations expenses   per patient .

 

 “COSTS — EFFECTIVENESS ” ANALYSIS .

The  study of the situation when  one and the same treatment purpose have been reached by two  medical methods. In this particular case “costs-effectiveness” analysis  method is more expedient one. This type of analysis allowes to take into consideration and  correlate  both taken  treatment procedurtes  expenses and efficiency (effect). It usually consistes of two stages :

1).     Medical technoligies application results clinical and economic analysis with the purpose to define value of avarage expenses per patient in both group.  

2).     «Costs-effectiveness”coefficients calculation and comparison for  each of patient treatment variants.   

It should be taken into consideration  that  the main condition for «Costs-effectiveness” analysis application is efficiency calculation uniform criterias  

«Costs-effectiveness” ratio is calculated under the formula  (3):

 

СЕА = ,

where  

СЕА «Costs-effectiveness” ratio gives expenses per efficiency 

numerator  – treatment avarage expenses per patient ;

denominator  – treatment effeciency .

 

From the economical point of view the most acceptable technology of two  is  that which  is chracterised by the less expenses per efficiency.  

 

RESULTS and DISCUSSION

In research centers were supplied with   ALMAG-01  working device and ALMAG-01 placebo device. The data of the number of   patients involved  into medical examination  see table 2. 

Table  2

The name of the research center

The group of Almag-01 working device

The group of placebo-device

The number of devices

The number of patients

The number of devices

The number of patients

1.

Kazan, Republican clinical hospital

1

26

1

25

2.

G.Kazan,  war veterans hospital ( rheumatology department)

1

4

1

5

3.

Goluboe urban settlement,  Moscow region,   the Central hospital of regenerative treatment

1

10

1

10

4.

Ryazan, LLC  " Sanatorium " Solodche »

1

15

1

15

5.

Yaroslavl, Regional clinical hospital

2

20

-

-

6.

 Moscow, City clinical hospital №17

-

-

2

40

 

Total

6

75

6

95

The total number of patients is  170  (75 of them applied Almag-01 working devi ( 44,1 %) ; and 95 patients applied Almag-01 placebo-device ( 55,9 %).

 

Groups general characteristic.

Patients description   is given in table 3. Patients applied Almag-01  working  device were  older  than those applied placebo-device  (68 and  53 years old correspondingly ).

 

 

Table  3

Medical examinations participants  demographic and clinical characteristic   

Characteristics and parameters

Алмаг-01 device group  

(n = 75), абс.

Placebo-device group  (n = 95) , абс.

Men

19

32

Women

56

43

Middle age

68,74±11,9

53,8±12,8

Disease

Gonarthrosis :

  • unilateral
  •  bilateral

15

18

 

27

23

Knee-joints deforming osteoarthrosis :

  • unilateral
  • bilateral

15

7

 

17

9

Generalized osteoarthrosis

16

10

Posttraumatic arthrosis

1

9

Rheumatoid arthritis

3

0

Disease aftereffects

Synovitis

6

8

Baker`s cyst

0

4

Concomitant diseases

Essential hypertension

21

16

Coronary heart disease (CHD)

3

5

Decompensated diabetes

6

4

Kidney and urinary tracts diseases

2

2

Gastrointestinal tract diseases

4

7

Respiratory apparatus diseases

3

5

Varicosity

3

4

Generalized atherosclerosis 

2

2

Obesity

10

8

 

 4.The description of  patients under medical examination .magnetic sensitivity

Table  4

Magnetic sensitivity parameters

 

Аlmag -01 device group  (n = 75), абс. (%)

Группа Placebo-device group  (n = 95) , абс. (%)

Low

31 (44%)

39 (41%)

Mean

41 (54,7%)

40 (42,1%)

High

3 (1,3%)

16 (16,9%)*

 

Note : * -Difference of  statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

Looking through the table we could not but notice  the  great part   of patients with high magnetic sensitivity in group of the patients using the placebo - device  with  an identical part of low sensitivity.

The data on joints functional activity parameters under the functional disorders  international scale  at the moment of the medical examination beginning  are given in table 5.

Functional disorders characteristics at the moment of examination    beginning according to functional disorders Inrerenational  scale indications 

Table 5

Characteristics and parameters

 

Аlmag-01 device group (n = 75), абс. (%)

Placebo-device group   (n = 95) , абс. (%)

Knee-joint  mobility function

Absolute disorders

0

0

Severe   disorders

4 (5,3%)

4 (4,2%)

Mean disorders

39 (52%)

55 (57,9%)

Light disorders

20 (26,7%)

32 (33,7%)

No disorders

6 (8%)

1 (1%)*

Disorders are not noted in the card

6 (8%)

3 (3,2%)

Knee joint  unrestricted (free)  movement  function

Absolute disorders

0

0

Severe   disorders

3 (4%)

8 (8,4%)

Mean disorders

35 (46,7%)

50 (52,6%)

Light disorders

14 (18,7%)

19 (20%)

No disorders

3 (4%)

1 (1%)

Disorders are not noted in the card

20 (26,6%)

17 (18%)

Short -distance walk

Absolute disorders

0

0

Severe   disorders

3 (4%)

7 (7,4%)

Mean disorders

27 (36%)

34 (35,8%)

Light disorders

26 (34,7%)

33 (34,7%)

No disorders

5 (6,7%)

3 (3,2%)

Disorders are not noted in the card

14 (18,6%)

18 (18,9%)

Not less than  1 km   distance walk 

Absolute disorders

1 (1,3%)

0

Severe   disorders

9 (12%)

20 (21%)

Mean disorders

30 (40%)

46 (48,4%)

Light disorders

11 (14,7%)

8 (8,4%)

No disorders

3 (4%)

2 (2,1%)

Disorders are not noted in the card

21 (28%)

19 (20,1%)

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

As it is seen  from the table 5 the given groups  according to knee joint both function, walk and  mobility indications  in group of the patients applied  Almag-01  working device ( besides evidently bigger number of patients with no  knee joint disorders mobility indications) , as compared to placebo- device group  patients  is  practically  equal to 8 % and 1 % accordingly, p <0,05.

 

 

 

Data   of extremity  injury joint flextion  angle and area of its extention  at the moment of examination begging    are given  in table 6

 

Characteristics and parameters

 

Аlmag -01 device group  (n = 75), абс.

Placebo-device group   (n = 95) , абс.

Injury joint  flexion (bending) angle  (◦)

71,88

64,9

Injury joint extension angle  (◦)

119,62

116,32

Injury  joint  area (volume), cm

47,15±10,35

 

50,05±8,35

 

 As it is seen from the data of table 6, at the beginning of medical examination both  groups   were practically comparable according  objective indications :  parameters of affected extremity injury joint bending  angle and injury area size,  however  in  Almag-01 device group the  affected extremity joint bending  angle   was bigger (71,88о and  64,9о accordingly)  and  the area of injured joint was  less  (47,15 сm and 50,05 см accordingly) than that one in placebo-device group. So at the begging of examination the  ALMAG-01 device group patients had better  objective indications of injuried joint as compared to  placebo device group.    

Estimated data on patients life quality according to  questionnaire EQ-5D 5 criteria at the beginning of medical examination is given  in the table 7.  As it is seen from the table at the beginning of medical examination in Almag-01 group the number of patients with mean and severe life quality disorders  according to both  self-service  and   daily activity factor was less as compare to the number of placebo-group that is 18,7% and 55,8%  and 61,3% and  80% accordingly .

 

 

Table  7

Assessment of patients state of health at the beginning of medical examination 

( according to  questionnaire EQ-5D 5 criteria)

 

 

 

 

Подпись: Assessment 	Аlmag -01 device group  (n = 75), абс. (%)	Placebo -device  group  (n = 95) , абс. (%)
Movement in space
I have no any problems relating to movement in space 	27 (36%)	22 (23,2%)
I have some problems relating to movement in space 	48 (64%)	55 (57,9%)
I am bedridden 	0	18 (18,9%)
Patient having mean and severe disorders 	48 (64%)	73 (76,8%)
No data 	-	-
Self-servicing 
I have no any problems in connection to self-servicing 	61 (81,3%)*	42 (44,2%)*
I have some problems when I wash dishes and  put my dress on 	14 (18,7%)*	36 (37,9%)*
I can`t wash and put the dress on myself 	0	17 (17,9%)*
Patient having mean and severe disorders 	14 (18,7%)*	53 (55,8%)*
No data 	-	-
Daily activity 
I have no any problems going daily activity  (work, study, household  and leisure activity )	29 (38,7%)*	19 (20%)*
I have some  problems relating to daily activity. 	44 (58,7%)	56 (58,9%)
I can`t do household activity 	2 (2,6%)*	20 (21,1%)*
Patient having mean and severe disorders 	46 (61,3%)*	76 (80%)*
No data 	-	-
Pain and discomfort 
I have no any pain and discomfort 	3 (4%)*	0*
I have  the sensation of little pain and discomfort 	45 (60%)	52 (54,7%)
I suffer from pain and discomfort 	27 (36%)	43 (45,3%)
Patient having mean and severe disorders 	71 (96%)	95 (100%)
No data 	-	-
Anxiety and depression 
I have the sensation of  anxiety and depression 	35 (46,7%)	33 (34,7%)
I have  the sensation of little  anxiety and depression 	39 (52%)	45 (47,4%)
I have the sensation of  expressed  anxiety and depression	1 (1,3%)*	17 (17,9%)*
Patient having mean and severe disorders 	40 (53,3%)	62 (65,3%)
No data 	-	-
 
 

 

 

 

 

 

 

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

 In Almag-01 device  group life quality index avaluated according to  a visual - analog scale had come to  0,51 (+/-0,11; median - 0,50, the 1-st quartile – 0,45, the  3rd quartile - 0,60)  and in  placebo- device group it  was equal to   0,59 (+/-0,13; a median - 0,58, the 1-st quartile - 0,50,  the 3rd quartile – 0,70).  Thus,  patients`life quality index, evaluated according to  visual - analog scale, in  Almag-01device group  was a little bit lower, than that  placebo device  group.

 Thus, the data analysis showed  that, despite  randomization carried (clauster one  and inside clasters in 3 cases), at the moment of the  medical examination  the groups were  not  comparable. On the whole, patients in the placebo-device group  had the worse indications  both of joint function ( according to  objective parameters and functional state international  parameters classifier )  and life qualities  ( evaluated according to visual - analog scale).

 

Clinical  results

 Treatment mean duration in  Almag-01 device group has come to  13,2 days  (+/- 5,2  days , median  – 13 ( the 1-st quartile  – 10, the 3rd quartile  – 17), in placebo-device group  – 10,4  days (+/- 6,9 days) , median  – 10 ( the 1-st quartile– 3, the 3rd quartile  – 17).

Information on magneto-therapy tolerance according to both groups examination results   is given in the table 8 .

Table 8

Magneto-therapy tolerance according to examination results

Tolerance

Аlmag -01  device group (n = 75), абс. (%)

Placebo-device group   (n = 95) , абс. (%)

Good

43 (57,3%)

84 (88,4%)*

Satisfactory

15 (20%)

11 (11,6%)

No data

17 (22,7%)

0

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

Thus, therapy good tolerance was more often noted  in placebo-  device group as compared with  Almag-01 device group  (88,4 % and 57,3 %, accordingly, p <0,05), so it is perhaps the evidence of the fact that  Almag-01device exposure. 

Both in  Almag-01 device group   and in  placebo-device group there was no notices of  any therapy  complications.

The analysis of injured  joint both bend angle dynamics and volume  has shown, that in  Almag-01 device group there was noted the bigger ,  but statistically not big  reduction of  injured  joint volume as compared   to   placebo-device group (3,9 sm and 2,9 sm accordingly) (tab. 9). Also  it was noted that in ALMAG-01 device group injured  joint  bend angle had been reduced  by 0,31о while in placebo-device group it is increased by 2,4о. Injured  joint extension angle increased in both groups, but it is necessary to notice that the increase in ALMAG-01 device group   was bigger as compared to placebo-device group  (-7,41 о and  -3,15 о accordingly).

Table 9

 Injured extremity function indications dynamic                                                                  ( both  bending angle and  injured  joint volune )

Characteristics and  parameters

Аlmag-01 device group  (N = 75)

Placebo-device group  (N = 95)

 

Index  before  examination 

Index after examination

Δ

Index  before  examination 

Index after examination

Δ

Affected joint bending angle  (◦)

71,88

71,57

0,31

64,9

67,3

-2,4

Affected joint extension angle  (◦)

119,62

127,03

-7,41

116,32

119,47

-3,15

Affected joint volume, см

47,15±10,35

 

43,25±4,4

 

3,9

50,05±8,35

 

47,15±9,4

 

2,9

 Впрочем, и на момент начала исследования в группе Алмаг-01 по  сравнению с группой аппарата-плацебо, так же было достоверно меньше больных с тяжелыми и умеренными нарушениями по показателям самообслуживания и повседневной активности.Patient life quality data estimated according to questioning EQ-5D 5 indexes  at the moment of examination termination are given in table 13. On the whole there was no difference on quality life  indications, but in ALMAG-01 device group as compared to placebo -device group  the number of patients suffering from pain and discomfort moderate and  severe disorders  was less. (38,7% and  62,1%).

In Almag-01 device  group life quality indix estimated  according to  a visual - analog scale has come to  0,62  (+/-0,12; median - 0,63, the 1-st quartile – 0,5, the  3rd quartile - 0,7)  and in  placebo- device group - 0,69 (+/-0,14; a median - 0,70, the 1-st quartile - 0,60, the 3rd quartile – 0,75).Thus, patients`life quality dynamic , estimated according to  visual - analog scale in  Almag-01device group  came to 0,11 points. Thus, life quality dynamic, estimated according to  visual - analog scale in  placebo-01device group  came to 0,1 points. So there were no noted  evident differences in  life quality dynamic estimated  according  to questioning EQ-5D 5 parameters. 

 Data on life quality dynamics, estimated according to  ED-5D questionnaire  5 parameters are   given in  tab. 10. In both groups there was noted statically considerable  reduction of the number of patients suffering from life quality   moderate or  severe disorders according to questioning EQ-5D 5 parameters, except for self-servicing parameter in Almag-01 device group.  

In placebo-device group as compared to Almag-01 device group  there was noted more evident reduction of the number of patients suffering from suffering from  moderate or  severe disorders ( except for  pain and discomfort) according to: space removal index ( 29,4% and 26,7%  accordingly); self-servicing index (26,3% and 1,3% accordingly); day-to-day activity (52% and  33,3% accordingly); pain and discomfort  index (37,9% and  57,3% accordingly); anxiety and depression (43,2% and  30,6% accordingly. So Almag-01 device greatly influenced  only the life quality relating to pain and discomfort as compared to placebo-device. But taking into account the course of treatment  which is not long it is impossible to speak about considerable change of functional indexes.  But nevertheless the pain reduction is the evidence of Almag-01 positive clinical effect.     

Table  10

Life quality indexes dynamic ( according  to questioning EQ-5D 5 parameters.)

 

 

 

 

Index

Аlmag-01 device  (n = 75) , абс. (%)

Plcebo device (n = 95), абс. (%)

 

Index  before treatment

Index after treatment

Δ , % patients

Index  before treatment

Index after treatment

Δ , % patients

абс.

(%)

абс.

(%)

Patients suffering from moderate or severe disorders according to “Space removal “ index

48 (64%)*

28 (37,3%)*

20

26,7

73 (76,8%)*

43 (47,4%)*

30

29,4

Patients suffering from moderate or severe disorders according to “Self-servicing” index

14 (18,7%)

13 (17,4%)

1*

1,3

53 (55,8%)*

28 (29,5%)*

25*

26,3

Patients suffering from moderate or severe disorders according “Day-to-day activity”

46 (61,3%)*

21 (28%)*

25*

33,3

76 (80%)*

21 (28%)*

55*

52

Patients suffering from moderate or severe disorders according «pain and discomfort “ index

71 (96%)*

29 (38,7%)*

42

57,3

95 (100%)*

59 (62,1%)*

36

37,9

Patients suffering from moderate or severe disorders according «Anxiety and depression»  index.

40 (53,3%)*

17 (22,7%)*

23*

30,6

62 (65,3%)*

21 (22,1%)*

2*

43,2

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

 

 Functional indications  dynamic data estimated according to Functional Disorders International Scale is given in table 11 and 12.  

Table 11 says that  there was not find out any statistically evident differences  inside the groups, but the  joints  mobility   function  positive dynamic with their  light  disorders  was more marked in  ALMAG-01device group as compared to placebo-device group ( 21,3% and 9,5% accordingly)

 

 

 

 

Table  11

“ Knee-joint mobility function” index dynamic

( functional disorders international scale)

Index

Аlmag-01 device  (n = 75)

Placebo device  (n = 95)

Knee -joint mobility function

Index before treatment

Index after treatment

Δ, % patients

Index before treatment

Index after treatment

Δ, % patients

абс.

(%)

абс.

(%)

Absolute disorders

0

0

0

0

0

0

0

0

Severe and moderate disorders

43 (57,3%)

31 (41,3%)

-12

16

59 (62,1%)

44 (46,3%)

-15

15,8

Light disorders  and  their absence

26 (34,7%)

42 (56%)

-16*

21,3

33 (34,7%)

42 (44,2%)

-9*

9,5

No data

6 (8%)

2 (2,7%)

4

5,3

3 (3,2%)

9 (9,5%)

-6

-6,3

Knee joint  both volume and  free mobility function

Index before treatment

Index after treatment

Δ, % patients

Index before treatment

Index after treatment

Δ, % patients

абс.

(%)

абс.

(%)

Absolute disorders

0

0

0

0

0

0

0

0

Severe and moderate disorders

38 (50,7%)

31 (41,5%)

-7

9,2

58 (61%)

44 (46,4%)

-14

14,6

Light disorders  and  their absence

17 (22,7%)

24 (31,9%)

-7

9,2

20 (21%)

31 (32,6%)

-11

11,6

No data

20 (26,6%)

20 (26,6%)

0

0

17 (18%)

20 (21%)

-3

-3

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

 

The table 12 says that there are  no statistically evident changes of “ Walking and  locomotion ” inications .In placebo device group  there was no  statistically significant changes according to short distance walking. But nevertheless in placebo  device group there was noted statistically big reduction of patients` number with severe and moderate abnormalities on not less than 1km walk distance indications from 69,4% до 46,3%) and increase in patients` number  with slight abnormalities on   the same indication ( from 10,5% to 31,6%). If we compare two groups it is necessary to note the bigger number of patients with slight abnormalities or their  absence on “ Short distance wealking” indications in Almag-01 device group  as  compared to the patients in placebo device group  ( 14,6% and и 4,2% accordingly )         

Table  12

 Dynamic of “ Walking and locomotion” index

   ( Functional disorders international scale) 

Index

Аlmag-01device  (n = 75)

Placebo device  (n = 95)

Short distance walk

Index before treatment

Index after treatment

Δ , % patients

Index before treatment

Index after treatment

Δ , % patents

абс.

(%)

абс.

(%)

Absolute disorders

0

0

0

0

0

0

0

0

Severe and moderate disorders

30 (40%)

22 (29,3%)

-8

10,7

41 (43,2%)

32 (33,7%)

-9

9,5

Light disorders  and  their absence

31 (41,4%)

42 (56%)

11*

14,6

36 (37,9%)

40 (42,1%)

4*

4,2

No data

14 (18,6%)

11 (14,7%)

3

3,9

18 (18,9%)

23 (24,2%)

5

5,3

One km ( not less) walk

Index before treatment

Index after treatment

Δ, % patients

Index before treatment

Index after treatment

Δ, % patients

абс.

(%)

абс.

(%)

Absolute disorders

1 (1,3%)

0

1

1,3

0

0

0

0

Severe and moderate disorders

39 (52%)

30 (40%)

-9*

12

66 (69,4%)*

44 (46,3%)*

-22*

23,1

Light disorders  and  their absence

14 (18,7%)

25 (33,3%)

11

14,7

10 (10,5%)*

30 (31,6%)*

20

21,1

No data

21 (28%)

20 (26,6%)

1

1,4

19 (20,1%)

21 (22,1%)

-2

-2

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

 

Information  on treatment in the hospital conditions  is given into table  13.

Table  13

 

 

Аlmag -01 device group  (n = 75), абс. (%)

Placebo device group  (n = 95) , абс. (%)

Treatment in hospital conditions

44 (58,7%)

61 (64,2%)

No treatment in hospital conditions

21 (28%)

25 (26,3%)

No data

10 (13,3%)

9 (9,5%)

 

The patients stay in hospital from Almag-01 device group - 15,7 days    (+/-3,9 days; medine  – 16, 1st quartile – 12, 3rd quartile - 18),  from placebo device  – 20,4 days  (+/-3,8 days; medine – 21, 1st quartile – 18, 3rd quartile  - 22). Though equal number of patients have got treatment in hospital ( 58,7% from  Almag-01 device group and 64,2% in placebo-device group) the treatment course was different  for  both groups. This can be explained by  impossibility to compare groups equally  at the moment of  examination beginning   (in placebo-device group the patients had much more severe disease  condition) .

Information  on temporary  invalidity are given in tab. 14.

Table  14

 

Аlmag -01 device group (n = 75), абс. (%)

Placebo device group  (n = 95) , абс. (%)

Temporary  invalidity

32 (42,7%)

43 (45,3%)

No signs of temporary  invalidity

2 (2,6%)*

10 (10,5%)*

No data

41 (54,7%)

42 (44,2%)

Note : * -Difference of   statistical adequacy  (p <0,05), Fisher criterion with Yets amendment

 

Thus, summarizing the received data on clinical efficiency, it is possible to make the following conclusions:

· Device Almag-01 greatly   influenced  life quality  with regard to  pain and discomfort as compared to placebo- device, as for the other questionnaire EQ-5D indications the results were better  in placebo-device group. 

 

 

 

 

 

 

 

 

 

 

 

 

Общее количество используемых лекарственных средств составило 128 наименований (табл. 15). В группу «А» затрат вошли 26 наименования ЛС, в группу «В» затрат вошли 26 наименования ЛС, в группу «С» затрат вошли 75 наименований ЛС. Общие затраты на лекарственные средства в двух группах (n=170) составили 469 238 рублей.

 

The clinical-economic analysis

The total amount of  used medical preparations came to  128 names:  (tab. 15). group " A "   included 26 names of medical preparations;  group " B " - 26 names; group " C " -  75 names. The total  expenses for medical preparation  in two groups came to  469238 roubles.

Table  15

Medical preparations general  АВС-analysis

The international not patented name

Total  costs , rub.

Percent

Cumulative percent

 «А» group  expenses

Diclofenac, ampoule .

44138,00

9,41%

9,41%

Nimesulid, tablet .

40185,00

8,56%

17,97%

Cephatholine

33945,00

7,23%

25,20%

Betametazon

29624,00

6,31%

31,52%

Nimesulid,suspension .

27377,60

5,83%

37,35%

Cyanocabolamin

19140,00

4,08%

41,43%

Ibuprofen, tablet.

18768,00

4,00%

45,43%

Diacerin

16833,00

3,59%

49,02%

Aphlutop , amp.

14740,00

3,14%

52,16%

Diclofenac, tabl.

13950,00

2,97%

55,13%

Benfotiamine + Pyridoxine 

12285,90

2,62%

57,75%

Chloride natrium  

11836,00

2,52%

60,27%

Sulphate chondoitinume

8560,00

1,82%

62,10%

Dexamethasone

7840,00

1,67%

63,77%

Dextrose

7820,00

1,67%

65,43%

Meldonium

7140,00

1,52%

66,96%

Methoprolol

7068,00

1,51%

68,46%

Nimesulyd, suspen.

7040,00

1,50%

69,96%

Omeprazol

6859,00

1,46%

71,42%

Ascorbic acid

6832,00

1,46%

72,88%

Glucosamine+ chondroitin sulfate

6543,00

1,39%

74,27%

Hesperidin +Diosmin

6300,00

1,34%

75,62%

Pentoxyphillin , tabl.

6222,00

1,33%

76,94%

Alphluton, amp.

6000,00

1,28%

78,22%

Pyridoxine

5776,00

1,23%

79,45%

Thiamine +Escin

5363,20

1,14%

80,60%

 «B» group expenses 

Actovegin

4720,00

1,01%

81,60%

Magnesium sulfate

4678,00

1,00%

82,60%

Chondroitin sulfate , solution

4400,00

0,94%

83,54%

Alphosphate choline

4320,00

0,92%

84,46%

Amlodipinum

4287,00

0,91%

85,37%

Melocsicam, solution

3712,50

0,79%

86,16%

Nifedipine

3537,00

0,75%

86,92%

Cerebrolizin

3000,00

0,64%

87,55%

Thioctic acid , tabl.

2688,00

0,57%

88,13%

Lornoxicam

2672,00

0,57%

88,70%

Perindopril

2620,00

0,56%

89,26%

Ketorolak, solution

2610,00

0,56%

89,81%

Pentoxyfiline, solution

2369,00

0,50%

90,32%

Xanthol nicotinat

2160,00

0,46%

90,78%

 Hondoitine Sulphate , capsule

2154,00

0,46%

91,24%

Indapamid retard , tabl. .

1916,4

0,41%

92,06%

Enalapril

1886,00

0,40%

92,46%

Thioctic acid , solution

1668,00

0,36%

92,82%

Meloxicam , tabl.

1663,00

0,35%

93,17%

Traumel  С, ampoule.

1584,00

0,34%

93,51%

Pyracetam

1552,00

0,33%

93,84%

Natrium enoxaparin

1238,00

0,26%

94,10%

Thrimetazin

1156,40

0,25%

94,35%

Isosorbide dinitrate

1143,60

0,24%

94,59%

Amino-phenylbutyric acid

1000,00

0,21%

94,81%

Levofloxacin

960,00

0,20%

95,01%

«C» group expenses 

Procaine

928,40

0,20%

95,21%

Rozuvastatinum

920,00

0,20%

95,41%

Formoterol

910,00

0,19%

95,60%

Methylphenylthiomethyl-dimethylaminomethyl   -hydrooxibromindol carboxylic acid ethyl alcohol

900,00

0,19%

95,79%

Levothyroxine natrium

891,00

0,19%

95,98%

Lozatran

850,00

0,18%

96,16%

Natrium metamizol

805,60

0,17%

96,33%

Ipidakrin, solution

783,00

0,17%

96,50%

Phelodipin

754,78

0,16%

96,66%

Lysinopril

690,00

0,15%

96,81%

Diclofenac, tablet .

651,00

0,14%

96,95%

Sibutramin

637,50

0,14%

97,08%

Indapamid+ Perindapril, tabl.

624,00

0,13%

97,22%

Bisoprolol

615,00

0,13%

97,35%

Indapamid+ Perindapril forte, tabl.

610,60

0,13%

97,48%

Indapamid, tabl.

606,25

0,13%

97,61%

Nicotinic acid

606,00

0,13%

97,74%

Ethylmetilhidroxipiridin  sukcinat

576,00

0,12%

97,86%

Pyridoxin +Tiamin +Cyancobalamin

512,00

0,11%

97,97%

Vinpocetine

502,20

0,11%

98,08%

Tamsulocin

494,00

0,11%

98,18%

Ipidakpin , tabl.

487,20

0,10%

98,28%

Aminophylline

472,50

0,10%

98,39%

 Sandy Bessmertnic flowers flavonoid  

441,00

0,09%

98,48%

Fosinopril

436,80

0,09%

98,57%

Atorvastatin

409,40

0,09%

98,66%

Nimesulid, gel

398,70

0,08%

98,74%

Metronidasol

360,00

0,08%

98,82%

Chondroitin sulfate, ointment

353,32

0,08%

98,90%

Methyletylpyridinol

332,00

0,07%

98,97%

Soluble insulin

328,68

0,07%

99,04%

Furosemid

257,40

0,05%

99,09%

Diclofenac, ointment

228,00

0,05%

99,14%

Paracetamol +Tramadol

219,78

0,05%

99,19%

Acetylsalicylic acid

204,50

0,04%

99,23%

Thrombo-АСС, tabl..

182,70

0,04%

99,27%

Acetylcystein

180,00

0,04%

99,31%

Zopyclon

180,00

0,04%

99,35%

Spironolactone

180,00

0,04%

99,39%

Acetylsalicylic acid

176,40

0,04%

99,42%

Pancreatine

170,10

0,04%

99,46%

Iprathropy bromide +phenotherol

162,00

0,03%

99,49%

Ketoprofen , cream

160,66

0,03%

99,53%

Rosa brier  fruits extract

151,20

0,03%

99,56%

Dipiridamol

146,25

0,03%

99,59%

Glyclasid

140,40

0,03%

99,62%

Acetylsalicylic acid+ magnesium hydroxide

121,88

0,03%

99,65%

Natrium heparine

115,94

0,02%

99,67%

Agomelatin

113,75

0,02%

99,70%

Karbamasepin

108,00

0,02%

99,72%

Domperidon

107,50

0,02%

99,74%

Tramadol

102,00

0,02%

99,76%

Allopurinol

100,80

0,02%

99,79%

Loratadine

100,00

0,02%

99,81%

Almagel, suspension.

96,00

0,02%

99,83%

Hydrochloriasid

90,00

0,02%

99,85%

Phenotherol

79,96

0,02%

99,86%

Glibenclamid

64,80

0,01%

99,88%

Diazepam

64,50

0,01%

99,89%

Aloes, ampul .

60,00

0,01%

99,90%

Theopek, tabl.

60,00

0,01%

99,92%

Thiamine

51,00

0,01%

99,93%

Аminodaron

48,00

0,01%

99,94%

Diclofenac, cream

45,20

0,01%

99,95%

Baclofen , 10 mg.

40,50

0,01%

99,96%

Ginkgo biloba ( maidenhair tree) leaves extract 

40,00

0,01%

99,96%

Ibuprofen +Levomentol

33,88

0,01%

99,97%

Verapamil

32,76

0,01%

99,98%

Bile

26,5

0,01%

99,98%

Trokserutin

24,36

0,01%

99,99%

Thioredasin

23,00

0,00%

99,99%

Kaptopril

20,00

0,00%

100,00%

Bromhexine

11,52

0,00%

100,00%

Bromdygidrochlorphenylbenzodiazepin

2,28

0,00%

100,00%

Aphlegan , amp.

2,25

0,00%

100,00%

 

 Medical preparation expenses  in Almag-01 device group (n=75) came to 173 494 roubles. Expenses АВС-Analysis is  given in tab. 16.  Medical services expenses per patient came to 2 313 roubles.

 

 

 

 

 

 

 

 

Table 16

Medical preparation expenses АВС-Analysis  in Almag-01 device group

 

The international not patented name

Obligatory medical insurance costs , rub.

Cost %

Expenses cumulative  %

 «А» group Expenses

Nimesulide, tabl.

31929,00

18,33

18,33

Nicotinic acid, ampuls

19720,64

11,32

29,65

Nimesulid, suspension..

14133,88

8,11

37,77

Ibuprofen, tabl..

14115,83

8,10

45,87

Magnesium sulfate, amp.

11422,86

6,56

52,43

Alflutop

11086,28

6,36

58,79

Chondiotin sulphate, powder

7886,75

4,53

63,32

Chondiotin sulphate, capsule

6712,69

3,85

67,17

Pentoxyilline tabl.

6107,23

3,51

70,68

Metoprolol, tabl.

4616,53

2,65

73,33

Aflutop

4512,73

2,59

75,92

Aktovegen

4452,56

2,56

78,48

Tiamin+Escin

4033,78

2,32

80,80

«В» group Expenses

Glucosamin +Chondroitine  sulphate

2700,87

1,55

82,35

Benphotiamin +Pyridoxin

2692,75

1,55

83,89

Omepazol

2454,93

1,41

85,30

Cerebrolisin

2256,37

1,30

86,60

Cyanokabolamin

2181,15

1,25

87,85

Thioctic acid, tab.

1654,67

0,95

88,80

Meloxikam

1432,04

0,82

89,62

Thioctic acid am.

1286,13

0,74

90,36

Amlodipin, tab.

1204,34

0,69

91,05

Nifedipine

1175,12

0,67

91,73

Hesperidin +Diosmin

1094,34

0,63

92,35

Doxilamin

1077,98

0,62

92,97

Sybutamin

972,49

0,56

93,53

Meloxikam , amp.

863,06

0,50

94,03

Phormotherol

694,00

0,40

94,43

Sodium chlorides

661,87

0,38

94,81

Traumel  С

595,68

0,34

95,15

Pyridoxin

571,61

0,33

95,48

«С»  group expenses

Perindopril

541,53

0,31

95,79

Metphormin

524,23

0,30

96,09

Diclofenac,tabl.

489,63

0,28

96,37

Meltdown , amp.

473,84

0,27

96,64

Lysinopril

458,79

0,26

96,90

Diclofenac, аmp.

455,03

0,26

97,17

Enlapril, tabl.

415,17

0,24

97,40

Aminophenilbutyric acid

376,06

0,22

97,62

Ipidakrin

366,43

0,21

97,83

Vinocetin

362,90

0,21

98,04

Chondriotin sulphate, ointment

294,83

0,17

98,21

Lozatran

272,64

0,16

98,36

Natrium levothyroxine

260,61

0,15

98,51

Pentoxifiline , amp.

259,48

0,15

98,66

Pyridoxin+Тiamin+Cyanko-balamin

252,71

0,15

98,81

Bysoprolol

203,07

0,12

98,92

Nymesulid, gel

184,53

0,11

99,03

Paracetamol +Tramadol

165,30

0,09

99,12

Thrombo-АСС

137,41

0,08

99,20

Ketorolac

135,38

0,08

99,28

Acetylsalicylic acid

132,67

0,08

99,36

Dexamethasone

126,36

0,07

99,43

Methylethylpyridinol

124,85

0,07

99,50

Atorvastatin

120,49

0,07

99,57

Indapamid+Perindapril

90,25

0,05

99,62

Karbamazepin

81,23

0,05

99,67

Loratadin

75,21

0,04

99,71

Acetylsalicylic acid+Magnesium hydroxide

74,74

0,04

99,76

Phelodipin

69,4

0,04

99,80

Hydrochlorotiasid 

67,69

0,04

99,84

Spironolactone

67,69

0,04

99,88

Glylaside

52,80

0,03

99,91

Natrium heparin

47,38

0,03

99,94

Allopurinol

37,91

0,02

99,96

Diclofenac, gel

34,00

0,02

99,98

Imbuprophen+Levomentol

25,48

0,01

99,99

Lornoxikam

24,07

0,01

99,99

Isosorbide dinitrate

21,06

0,01

99,99

Troxerutin

18,32

0,01

99,99

Indapamid

17,3

0,01

99,99

Dilaciniate ginkgo leaves extract

15,04

0,01

99,99

Glibenclamid

12,64

0,01

99,99

Verapamil , tabl.

7,82

0,00

99,99

Medical bile

3,35

0,00

100,00

 

 Medical preparation expenses  in Almag-01 placebo-device group (n=95) came to 295 744 roubles.  АВС-Analysis   is  given in tab. 17.  Medical procedures expenses per patient came to 3 113 roubles.

Таble  17

Medical preparation expenses АВС-Analysis  in placebo device group

The international not patented name

Costs , rub.

Cost %

Expenses cumulative  %

 «А» group expenses

Pyracetam

36892,15

17,64

17,64

Omeprazol

15250,60

7,29

24,94

Cephasolin

14937,72

7,14

32,08

Magnesium sulfate

13366,72

6,39

38,47

Nicotinic acid

13360,12

6,39

44,86

Betametazin

13036,24

6,23

51,09

Nimesulid

12596,80

6,02

57,12

Alphlutop

11327,06

5,42

62,54

Diacerin

7407,47

3,54

66,08

Cyanokabolamin

7146,52

3,42

69,50

Diclofenac, tabl.

6138,79

2,94

72,43

Sodium chlorides

4821,26

2,31

74,74

Chondroitine Sulfate , capsule .

4716,97

2,26

76,99

Benphotiamin +Piridoxin

3831,00

1,83

78,83

Dextroza, vial.

3441,24

1,65

80,47

 «В» group expenses

Dexametasone

3376,11

1,61

82,09

Diclofenac, amp.

3188,65

1,52

83,61

Ascorbic acid

3006,47

1,44

85,05

Meldony

2864,77

1,37

86,42

Alphosfat cholina , аmp.

2772,36

1,33

87,74

Piridoxin

2207,32

1,06

88,80

Hesperidin +Dyosmin

2132,07

1,02

89,82

Pentoxiphillin , аmp.

1301,25

0,62

90,44

Glucosamine +chondroitin sulfate

1299,05

0,62

91,06

Lornoxikam

1161,75

0,56

91,62

Meloxikam, аmp.

1128,75

0,54

92,16

Ketorolak

1069,34

0,51

92,67

Nicotinat  xantole

950,52

0,45

93,12

Perindopril

836,11

0,40

93,52

Thioctic acid , аmp.

752,50

0,36

93,88

Enalapril

587,04

0,28

94,16

Indapamid

576,65

0,28

94,44

Metphormin

549,19

0,26

94,70

 Natrium Enoxaparin

544,79

0,26

94,96

Indapamid+Perindapril

510,29

0,24

95,21

 «С» group expenses

Thrimetazin

508,88

0,24

95,45

Aktovegin

492,86

0,24

95,69

Levophloxacin

422,45

0,20

95,89

Methoprolol

409,25

0,20

96,08

Procain

408,55

0,20

96,28

Rozuvastatin

404,85

0,19

96,47

Methylpheniltheometil-dimethylaminomethyl -  hydrooxibgromindol carboxelic acid ethyl alcohol

396,05

0,19

96,66

Natrium metamizol  

354,51

0,17

96,83

Traumel  С

348,52

0,17

97,00

Ipidakrin , amp.

344,56

0,16

97,16

Lisinopril

303,64

0,15

97,31

Idroxipiridin Ethylmethyl succinate

253,47

0,12

97,43

Natrium levothyroxine

239,61

0,11

97,54

Sibutramine

225,53

0,11

97,65

Vinocetine

221,00

0,11

97,76

Aminophenilbutyric acid

220,03

0,11

97,86

Pentoxyphillin, tab.

219,59

0,11

97,97

Tamsulozine

217,39

0,10

98,07

Lozathran

214,53

0,10

98,17

Ipidakrine , tab.

214,40

0,10

98,28

Thioctic acid

211,23

0,10

98,38

Aminophilline

207,93

0,10

98,48

Flavonoid  of sandy immortelle  flowers

194,06

0,09

98,57

Fosinopril

192,22

0,09

98,66

 

Verapamil

171,62

0,08

98,74

Methronidazol

158,42

0,08

98,82

Chondroitin sulfate, inntment

155,48

0,07

98,89

Bisoprolol

151,82

0,07

98,97

Soluble insulin

144,64

0,07

99,04

Furosemide

113,27

0,05

99,09

Atorvastatinum

109,66

0,05

99,14

Diclifenac , inntment

100,33

0,05

99,19

Nimesulide, suspension .

98,57

0,05

99,24

Acetylsalicylic acid

89,99

0,04

99,28

Acetylcysteine

79,21

0,04

99,32

Zopiklon

79,21

0,04

99,36

Pyridoxin+Тiamin+Cyankobalamin

77,45

0,04

99,39

Isosorbide dinitrate

76,39

0,04

99,43

Thrombo-АСС

75,69

0,04

99,47

Pancreatine

74,85

0,04

99,50

Methylethylpyridinol

73,05

0,03

99,54

Iprathronia bronide +Phenothiazine

71,29

0,03

99,57

Ketoprofen, cream

70,70

0,03

99,61

Аmlodipin

68,74

0,03

99,64

Nimesulide, gel.

67,49

0,03

99,67

Flavonoid  of sandy immortelle  flowers

66,54

0,03

99,70

Dipiridamol

64,36

0,03

99,73

Agomelatin

50,06

0,02

99,76

Domperidon

47,31

0,02

99,78

Tramadol

44,89

0,02

99,80

Loratadin

44,01

0,02

99,82

Almagel

42,25

0,02

99,84

Spironolackton

39,61

0,02

99,86

Phenothrol

35,19

0,02

99,88

Glyclazid

30,89

0,01

99,89

Bile

29,57

0,01

99,90

Diazepam

28,38

0,01

99,91

Aloe , amp.

26,40

0,01

99,92

Teopek

26,40

0,01

99,93

Thiamine

22,44

0,01

99,94

Allopurinol

22,18

0,01

99,95

Amiodaron

21,12

0,01

99,96

Glibenclamid

21,12

0,01

99,97

Natrium heparinum

18,55

0,01

99,97

Baklophen

17,82

0,01

99,98

Acetylsalicylic acid+ magnesium hydroxide

9,90

0,00

99,98

Dilaciniate ginkgo leaves extract

8,80

0,00

99,99

Ambroxol

0,99

0,00

99,99

Hydrochlorotiasid

0,87

0,00

100,00

 

While in  carrying medical preparations expenses АВС-Analysis out  it was found out , that the expenses for not steroid anti-inflammatory means  in Almag-01 device group  were higher, than those  in placebo group  device . In order to exclude a possibility  of medical preparation influence the  effect which has been shown in medical examination, the frequency analysis of non steroid anti-inflammatory  medicament means  application in both groups (tab. 18) has been carried out.

Table  18

Not steroid anti-inflammatory means  application

 frequency analysis

 

The international not patented name

Number of NSAIMM in  Аlmag-01device group   (n=75), абс. (%)

Number of NSAIMM in placebo-device group  (n=95), абс. (%)

Acetylsalicylic acid

7 (9,3%)

10 (10,5%)

Diclofenac

16 (21,3%)

53 (55,7%)

Ketoprofen

2 (2,6%)

4 (4,2%)

Ketorolak

1 (1,3%)

14 (14,7%)

Natrium metamizol

0

11 (11,5%)

Nimesulid

16 (21,3%)

13 (13,6%)

Total :

55,8%

110,2%

 

  As it is seen from the above table, in group of placebo-device group  NSAIM  were used  twice  as much  often (diclofenac  is much more than  often , ketoprofen  is practically twice often), as compared to Almag-01device group, except  nimesulid which was used practically twice  more often in Almag-01device group.

Thus, the most patients in placebo device group  took  NSAIM , that could influence results of medical examination.

The total number of the rendered medical services amounted to 135. Rendered medical services АВС-analysis is given in table 19. «А» group expenses  included   29 medical services,  «В» group  - 37 medical services ,  «С» group  – 69 medical services. The carried analysis showed that among the medical services the most expensive ones were as follows:  therapist and  physiatrist сonsultations(9,2 % and 9,0 %  expenses accordingly), application of  medical bile compress (5,4 %), measurement of arterial pressure (7,3 %),  magnetotherapy and  exercise magnetomagnetotherapy (4,5 % and 3,8 % accordingly), magnetoresonance therapy (4,5 %),  both compresses and  diet prescription  (3,5 % and 3,3 % accordingly), electrocardiography (2,4 %), the common urine analysis  (2,1 %), coagulogramm (2,0 %), measurement of both pulse and cardiac contraction   frequency  (2,0 % and 2,0 % accordingly), knee joints X-ray photography  (2,0 %). Thus the great  share of magnetoresonance therapy, compresses are  caused by services high cost  at their rather infrequent application.  At the same time arterial pressure measurement , exercises therapy,  pulse and cardiac reductions examination   were carried out very often   with  these services low cost .

Thus the great part of magnethresonance therapy and  compresses are stipulated for  by services high cost, with  their rather infrequent use. At the same time  both the arterial pressure, pulse and  cardiac contraction rate  measurement, physiotherapy exercises  were carried out very often  with services  low cost.

Table  19

Medical services АВС-analysis

Medical services

Tariff                  per med.service.

Total number

Total cost rub.

%

Cumulative interest

 «А»  group expenses

Therapist consultation

77,82

554

43112,28

9,213

18,223

Physiotherapist consultation

93,27

452

42158,04

9,009

25,541

  Peripheric arterias arterial pressure measurement

11,4

3004

34245,6

7,319

30,972

Night medical bile compress  

488,7

52

25412,4

5,431

35,566

Knee joint magnetotherapy

26,28

818

21497,04

4,594

39,459

The physiotherapy exercises aimed to left knee joint  function  and  mobility recovery. 

15,45

1179

18215,55

3,893

43,152

Backbone  lumbar part magnetic resonant tomography

5760

3

17280

3,693

46,703

Knee-joint compress

488,7

34

16615,8

3,551

50,018

Diet

74,94

207

15512,58

3,315

52,462

Electrocardiography

87,96

130

11434,8

2,444

54,629

Urine overall  analysis

47,16

215

10139,4

2,167

56,725

Coagulogramme

121,08

81

9807,48

2,096

58,775

Pulse examination

3,3

2907

9593,1

2,050

60,821

Heartbeat rate measurement

3,3

2902

9576,6

2,047

62,837

Knee joint Х-ray photograph

168,45

56

9433,2

2,016

64,717

Blood group and rhesus factor

118,89

74

8797,86

1,880

66,384

Blood protein and protein fraction analysis

86,64

90

7797,6

1,666

68,009

Blood general clinical analysis

28,59

266

7604,94

1,625

69,412

Both haemoglobin, leucocytes determination

25,74

255

6563,7

1,403

70,514

Novocainum compress

76,98

67

5157,66

1,102

71,606

Blood electrolits

86,58

59

5108,22

1,092

72,697

Traveling  pulsed magneto-therapy

37,26

137

5104,62

1,091

73,769

physiotherapy exercises doctor`s consultation

100,41

50

5020,5

1,073

74,840

Surgeon consultation

82,14

61

5010,54

1,071

75,896

Spinal column lumbosacral part massage

42,96

115

4940,4

1,056

76,935

Physio-procedures

26,28

185

4861,8

1,039

77,935

Blood glucose determination

23,16

202

4678,32

1,000

78,882

Variational intervalometric

94,26

47

4430,22

0,947

79,790

Knee joint massage

42,96

99

4253,04

0,909

80,664

«В» group expenses

Acupuncture

46,47

88

4089,36

0,874

81,483

Neurologist consultation

75,15

51

3832,65

0,819

82,251

Hydromassage

69,03

52

3589,56

0,767

82,963

Sea salt bath

42,75

78

3334,5

0,713

83,671

Vibromassage spinal column

69,03

48

3313,44

0,708

84,309

Cervico-callar zone massage

28,68

104

2982,72

0,637

84,919

Blood analysis

22,83

125

2853,75

0,610

85,504

Blood kreatine analysis

22,83

120

2739,6

0,585

86,065

Medical phonophoresis

37,5

70

2625

0,561

86,621

Blood bilirubin analysis

18,99

137

2601,63

0,556

87,134

Curative swimming

80,04

30

2401,2

0,513

87,612

Laser therapy

44,7

50

2235

0,478

88,044

Knee joint dry heat procedure

40,47

50

2023,5

0,432

88,462

Blood general protein analysis

15,39

127

1954,53

0,418

88,868

Inhalation

31,65

60

1899

0,406

89,247

Massage

19,74

90

1776,6

0,380

89,615

Cardiologist consultation

81,99

21

1721,79

0,368

89,965

Anti-HBchepatitis antibody  determination

26,37

62

1634,94

0,349

90,313

Rhematoid factor deteremination

77,67

21

1631,07

0,349

90,650

 Thoracal cell massage

39,33

40

1573,2

0,336

90,981

Water medical gymnastics

13,47

115

1549,05

0,331

91,283

Knee joint dry heat procedure

40,47

35

1416,45

0,303

91,576

Mechanic therapy

39,18

35

1371,3

0,293

91,868

Ozokeritotherapy

75,81

18

1364,58

0,292

92,140

Knee joints ultrasonic scanning

98,01

13

1274,13

0,272

92,404

Pelvic bones and hip joints Х-ray photograph

154,2

8

1233,6

0,264

92,651

Blood thrombinogen analysis

10,05

115

1155,75

0,247

92,896

Backbone massage  

28,68

40

1147,2

0,245

93,139

Aerocryotherapy

75,81

15

1137,15

0,243

93,379

Ophthalmologist consultation

124,5

9

1120,5

0,239

93,604

HIV antibody  determination

26,37

40

1054,8

0,225

93,829

Gynecologist consultation

131,64

8

1053,12

0,225

94,046

Wassermann reaction

26,76

38

1016,88

0,217

94,258

 Endocrinologist consultation

76,2

13

990,6

0,212

94,467

Thoracal cell Х-ray photograph

195,93

5

979,65

0,209

94,674

Medical gymnastics in group

16,68

58

967,44

0,207

94,879

Cholesterin

18,78

51

957,78

0,205

95,081

 «С» group expenses

Blood С-reactive fiber level examination

7,74

122

944,28

0,202

95,272

Circulatory shower

29,88

30

896,4

0,192

95,460

Abdominal cavity organs ultrasonic scanning

146,07

6

876,42

0,187

95,642

Iodide-bromine bath

42,75

20

855

0,183

95,825

 Foot vortical bath

42,75

20

855

0,183

95,994

Psychologist consultation

263,49

3

790,47

0,169

96,157

Urea blood analysis

6,48

118

764,64

0,163

96,317

Acupuncture  therapeutist consultation

93,27

8

746,16

0,159

96,474

Dry  СО2 bath

36,9

20

738

0,158

96,631

 Simulator practical training

36,69

20

733,8

0,157

96,787

Small pelvis organs ultrasonic scanning

121,74

6

730,44

0,156

96,938

Kinesy therapeutist consultation

100,41

7

702,87

0,150

97,077

Definition of red blood cells sedimentation rate

7,77

84

652,68

0,139

97,216

Backbone lumbar part  segmentary massage 

19,74

33

651,42

0,139

97,341

Glucocorticoid electrophoresis  

27,27

20

545,4

0,117

97,570

Darsonval -effect

26,28

20

525,6

0,112

97,680

Knee joint puncture

 

515,37

1

515,37

0,110

97,789

Colonoscopy

502,86

1

502,86

0,107

98,003

Dermatolo- venereologist consultation

124,8

4

499,2

0,107

98,104

«Soluks” lamp exposure

26,28

18

473,04

0,101

98,200

Oethopedist consultation

149,37

3

448,11

0,096

98,280

Diadynamic currents on foot

37,56

10

375,6

0,080

98,356

Rehabilitation -doctor`s consultation

118,38

3

355,14

0,076

98,430

 Knee joint arthroscopy

173,37

2

346,74

0,074

98,504

 Backbone cervical spine Х-ray photograph   

173,25

2

346,5

0,074

98,576

Individual medical gymnastics

66,48

5

332,4

0,071

98,717

Gastroenterologist consultation

82,11

4

328,44

0,070

98,787

Traumatologist  consultation

81,96

4

327,84

0,070

98,855

Urinologist consultation

104,58

3

313,74

0,067

98,919

Lungs flurography

74,85

4

299,4

0,064

98,981

Ankle joint Х-ray photograph 

98,01

3

294,03

0,063

99,044

Hip joint ultrasonic scanning

98,01

3

294,03

0,063

99,105

Back relaxing massage

28,68

10

286,8

0,061

99,167

Otorhinolaryngologist consultation

43,19

2

286,38

0,061

99,218

Lower extremities vesselsultrasonic 

60,36

4

241,44

0,052

99,269

Abdominal cavity dopplerography

118,02

2

236,04

0,050

99,318

Lung specialist сonsultation

76,23

3

228,69

0,049

99,366

Lower leg massage

22,8

10

228

0,049

99,413

Electroencephalography

220,14

1

220,14

0,047

99,459

Pickfluometry

53,82

4

215,28

0,046

99,504

Ophthalmoscopy

103,71

2

207,42

0,044

99,547

Manual  therapist consultation

100,41

2

200,82

0,043

99,588

Nose sinus appendages Х-ray photograph

192,66

1

192,66

0,041

99,628

Triglyceride determination

63,33

3

189,99

0,041

99,666

Capnography

58,71

3

176,13

0,038

99,703

Backbone lumbar part Х-ray photograph 

57,75

3

173,25

0,037

99,736

Stabilotraining

15,45

10

154,5

0,033

99,768

Pulsoximeter

10,05

15

150,75

0,032

99,800

Ultrasonic scanning kidney

146,07

1

146,07

0,031

99,828

Joints thermometry

135,63

1

135,63

0,029

99,856

Hair part head massage

15,81

8

126,48

0,027

99,878

Eye ground examination

103,71

1

103,71

0,022

99,896

Pneumotachometer

28,41

3

85,23

0,018

99,914

 Vascular surgeon consultation

76,08

1

76,08

0,016

99,944

Alkaline phosphotasis deternination

32,37

2

64,74

0,014

99,955

International normalized relation determination

50,85

1

50,85

0,011

99,965

Smear cytologic examination

49,95

1

49,95

0,011

99,971

High density lipoproteids determination

24,63

1

24,63

0,005

99,976

Low density lipoproteids determination

24,63

1

24,63

0,005

99,981

Deteremination of atherogenic  factor

24,63

1

24,63

0,005

99,986

 Uric acid determination  

22,35

1

22,35

0,005

99,990

Determination of hepatitis virus “C” to antibodies

20,13

1

20,13

0,004

99,998

Determination of prothrombin time

18,33

1

18,33

0,004

100,000

С-rebound protein determination

7,74

1

7,74

0,002

100,000

 

Table 20

Medical services` expenses  АВС-analysis in ALMAG-01 device group

Medical services

Tariff                  per med.service.

Services total number

Expenses per service  rub.

Expenses %

per medical  service

Expenses cumulative  % per medical service

 «А»  group expenses

 Therapist consultation

77,82

286

22256,52

11,55

20,747

Physiotherapist consultation

93,27

190

17721,3

9,197

26,352

Knee joint magnetotherapy

26,28

411

10801,08

5,605

31,097

Diet

74,94

122

9142,68

4,745

35,759

Measurement of  peripheral arteries arterial pressure

11,4

788

8983,2

4,662

38,748

Backbone lumbar part magnetic resonant tomography 

5760

1

5760

2,989

41,498

The physiotherapy exercises aimed to  left knee mobility function recovery

15,45

343

5299,35

2,75

44,034

Medical bile night compress

488,7

10

4887

2,536

46,557

Physioprocedures

26,28

185

4861,8

2,523

48,760

Blood  general  protein and protein  fractions analysis

86,64

49

4245,36

2,203

50,938

Urine general analysis

47,16

89

4197,24

2,178

53,038

Electrocardiography

87,96

46

4046,16

2,1

55,049

Knee joints X-ray photography

168,45

23

3874,35

2,011

57,047

Novocaine compress

76,98

50

3849

1,998

58,819

Physiotherapy exercises specialist consultation

100,41

34

3413,94

1,772

60,580

Knee joints massage

42,96

79

3393,84

1,761

62,220

Acupuncture

46,47

68

3159,96

1,64

63,840

Surgeon consultation

82,14

38

3121,32

1,62

65,457

General blood clinical  analysis

28,59

109

3116,31

1,617

66,962

Hydromassage

69,03

42

2899,26

1,505

68,431

Hemoglobin, leukocytes determination

25,74

110

2831,4

1,469

69,813

Coagulograme

121,08

22

2663,76

1,382

71,173

 Thoracal cell massage

42,96

61

2620,56

1,36

72,463

Pulse examination

3,3

753

2484,9

1,29

73,746

Palpitation rate measurement

3,3

749

2471,7

1,283

74,980

Blood group and rhesus factor

118,89

20

2377,8

1,234

76,189

Neurologist consultation

75,15

31

2329,65

1,209

77,265

Variation intervalometer

94,26

22

2073,72

1,076

78,335

Determination  of blood glucose

23,16

89

2061,24

1,07

79,360

Traveling magnetic field -therapy

37,26

53

1974,78

1,025

80,363

 «В» group expenses

Backbone vibromassage

69,03

28

1932,84

1,003

81,217

Blood electrolits

86,58

19

1645,02

0,854

82,048

Curative swimming

80,04

20

1600,8

0,831

82,852

Cervico-collar area massage  

28,68

54

1548,72

0,804

83,564

Mechano-therapy

39,18

35

1371,3

0,712

84,272

Ozokerito-therapy

75,81

18

1364,58

0,708

84,959

Blood analysis

22,83

58

1324,14

0,687

85,631

Knee joint dry heat

40,47

32

1295,04

0,672

86,269

Cardiology consultation

81,99

15

1229,85

0,638

86,890

Sea salt bath

42,75

28

1197

0,621

87,485

Backbone massage

28,68

40

1147,2

0,595

88,069

Phonophoresis

37,5

30

1125

0,584

88,629

Knee joints ultrasonic scanning

98,01

11

1078,11

0,56

89,188

Water medical gymnastics

13,47

80

1077,6

0,559

89,730

Blood  bilirubin analysis

18,99

55

1044,45

0,542

90,263

Creatinine  blood analysis

22,83

45

1027,35

0,533

90,747

Rheumatoid  factor determination

77,67

12

932,04

0,484

91,211

Laser therapy

44,7

20

894

0,464

91,655

Iodide-bromine bath

42,75

20

855

0,444

92,094

General protein blood analysis

15,39

55

846,45

0,439

92,510

Medical gymnastics

16,68

48

800,64

0,416

92,918

Thorax massage

39,33

20

786,6

0,408

93,305

Acupuncture specialist consultation

93,27

8

746,16

0,387

93,670

Kinesitherapeutist  consultation

100,41

7

702,87

0,365

93,953

Glucocorticoid electroohoresis

27,27

20

545,4

0,283

94,206

C level blood reactive protein examination

7,74

63

487,62

0,253

94,451

 "Solux” lamp exposure

26,28

18

473,04

0,245

94,691

Pelvic bones  and hip-bone joints X-ray photography

154,2

3

462,6

0,24

94,931

 «С» group expenses

Prothrombin blood analysis

10,05

43

432,15

0,224

95,379

Cholesterol

18,78

23

431,94

0,224

95,601

Foot vortical bath

42,75

10

427,5

0,222

95,811

Knee joints dry heat

40,47

10

404,7

0,21

96,016

Massage

19,74

20

394,8

0,205

96,214

Endocrine specialist consultation

76,2

5

381

0,198

96,411

Aerocryotherapy

75,81

5

379,05

0,197

96,606

Feet diadynamic currents

37,56

10

375,6

0,195

96,796

Little pelvic organs ultrasonic scanning

121,74

3

365,22

0,19

96,980

Rehabilitation -doctor consultation

118,38

3

355,14

0,184

97,160

Backbone cervical  part X-ray photography    

173,25

2

346,5

0,18

97,333

Individual medical gymnastics

66,48

5

332,4

0,173

97,497

Inhalation

31,65

10

316,5

0,164

97,658

Determination of erythrocytes sedimentation  speed

7,77

40

310,8

0,161

97,813

Circulatory shower

29,88

10

298,8

0,155

97,968

Orthopedist consultation

149,37

2

298,74

0,155

98,121

Hip-bone joints ultrasonic  scanning

98,01

3

294,03

0,153

98,272

Urea blood analysis

6,48

45

291,6

0,151

98,409

Gynaecologist consultation

131,64

2

263,28

0,137

98,546

Psychologist consultation

263,49

1

263,49

0,137

98,682

Darsonval -exposure

26,28

10

262,8

0,136

98,811

Oculist consultation

124,5

2

249

0,129

98,939

Traumatologist consultation

81,96

3

245,88

0,128

99,053

Electroencephalography

220,14

1

220,14

0,114

99,157

Manual therapeutist consultation

100,41

2

200,82

0,104

99,259

Backbone lumbar part segmentary massage

19,74

10

197,4

0,102

99,335

Belly cavity organs ultrasonic scanning

146,07

1

146,07

0,076

99,409

Otolaryngology specialist  consultation

143,19

1

143,19

0,074

99,475

Triglycerides determination

63,33

2

126,66

0,066

99,541

Head hear part massage

15,81

8

126,48

0,066

99,606

Dermatologist-venereologist consultation

124,8

1

124,8

0,065

99,660

Ophthalmoscopy

103,71

1

103,71

0,054

99,714

Eye ground examination

103,71

1

103,71

0,054

99,765

Ankle joints X-ray photography

98,01

1

98,01

0,051

99,808

Gastroenterologist consultation

82,11

1

82,11

0,043

99,848

Pulmonologist consultation

76,23

1

76,23

0,04

99,887

Vascular surgeon consultation

76,08

1

76,08

0,039

99,917

Capnography

58,71

1

58,71

0,03

99,947

Backbone lumbar part X-ray photography

57,75

1

57,75

0,03

99,973

Pulsoximetry

10,05

5

50,25

0,026

99,988

Pneumotachometer

28,41

1

28,41

0,015

100,00

Atherogenic coefficient determination

24,63

1

24,63

0,013

100,00

 

Table 21

Medical services` expenses  АВС-analysis in placebo -device group

Medical services

Tariff                                                                per  rendered service    rub.

Number of rendered  services

 Expenses per  service rub.

Expenses % per medical service

Expenses cumulative % per medical service

 «А»  group expenses

Medical  bile night compress

488,7

76

37141,2

12,72585

21,38161

Measurement of peripheral arteries arterial pressure

11,4

2216

25262,4

8,655764

29,75448

Physiotherapeutist consultation 

93,27

262

24436,74

8,372865

36,90038

Therapeutist consultation

77,82

268

20855,76

7,145898

42,59352

Medical bile compress on knee joint

488,7

34

16615,8

5,693143

47,01905

The physiotherapy exercises  amied  to left knee joint  function  and mobility recovery

15,45

836

12916,2

4,425533

50,9662

Backbone lumbar part magnetic resonance tomography

5760

2

11520

3,947147

54,631

Knee joint magnetotherapy

26,28

407

10695,96

3,664803

57,1626

Electrocardiography

87,96

84

7388,64

2,531601

59,61029

Coagylogramme

121,08

59

7143,72

2,447683

62,0458

Pulse examination

3,3

2154

7108,2

2,435513

64,48018

Heart beat rate measurement

3,3

2153

7104,9

2,434382

66,67992

Blood group and rhesus factor

118,89

54

6420,06

2,199733

68,86246

Diet

74,94

85

6369,9

2,182546

70,89845

Urine general analysis

47,16

126

5942,16

2,035988

72,8031

Knee joints X-ray photography

168,45

33

5558,85

1,904653

74,34106

Blood clinical general  analysis

28,59

157

4488,63

1,537958

75,61987

Hemoglobin, leukocytes determination

25,74

145

3732,3

1,278814

76,83699

Blood  general  protein and protein  fractions analysis

86,64

41

3552,24

1,217119

78,0236

Blood electrolyte

86,58

40

3463,2

1,186611

79,09599

Traveling pulsed magnetic  field therapy

37,26

84

3129,84

1,07239

79,9927

Determination  of  blood glucose

23,16

113

2617,08

0,896701

80,80011

 «В» group expenses

Variational intervalometry

94,26

25

2356,5

0,807418

81,59497

Backbone lumbosacral   part massage

42,96

54

2319,84

0,794857

82,32735

See salt bath

42,75

50

2137,5

0,732381

82,97466

Surgery consultation

82,14

23

1889,22

0,647312

83,56134

Blood kreatine analysis

22,83

75

1712,25

0,586676

84,12153

НВС (hepatites) antibodies determination

26,37

62

1634,94

0,560186

84,67199

Physiotherapy exercises specialist consultation

100,41

16

1606,56

0,550463

85,21421

Inhalation

31,65

50

1582,5

0,542219

85,74775

Blood bilirubin analysis

18,99

82

1557,18

0,533543

86,27185

Blood analysis

22,83

67

1529,61

0,524097

86,78683

Neurologist consultation

75,15

20

1503

0,514979

87,30078

Medical phonophoresis

37,5

40

1500

0,513951

87,79212

Cervicocollar area massage

28,68

50

1434

0,491338

88,26557

Massage

19,74

70

1381,8

0,473452

88,73861

Backbone vibromassage

69,03

20

1380,6

0,473041

89,19808

Laser therapy

44,7

30

1341

0,459473

89,64647

Novocaine compress

76,98

17

1308,66

0,448392

90,02614

Blood  general protien  analysis

15,39

72

1108,08

0,379666

90,38755

HIV antibody determination

26,37

40

1054,8

0,361411

90,73597

Vasserman reaction

26,76

38

1016,88

0,348418

91,08263

Knee joint dry heat

40,47

25

1011,75

0,34666

91,41829

Thorax X - ray photography

195,93

5

979,65

0,335662

91,73673

Acupuncture

46,47

20

929,4

0,318444

92,03534

Oculist consultation

124,5

7

871,5

0,298606

92,32973

Knee joints massage

42,96

20

859,2

0,294391

92,60398

Curative swimming

80,04

10

800,4

0,274244

92,8746

Gynaecologist consultation

131,64

6

789,84

0,270626

93,14412

Thorax massage

39,33

20

786,6

0,269516

93,40829

Palvis bones  and hip joints X - ray photography

154,2

5

771

0,264171

93,66804

Aerocriotherapy

75,81

10

758,1

0,259751

93,9209

Dry  СО2 bath

36,9

20

738

0,252864

94,17233

Training  exercises

36,69

20

733,8

0,251425

94,42257

Belly cavity organs ultrasonic scanning

 

146,07

5

730,35

0,250243

94,67217

Knee joint dry heat

40,47

18

728,46

0,249595

94,9201

Blood prothrombin  analysis

10,05

72

723,6

0,24793

95,15961

 «С» group expenses

Rheumatoid  factor determination

77,67

9

699,03

0,239512

95,39613

Hydromassage

69,03

10

690,3

0,23652

95,605

Endocrinologist consultation

76,2

8

609,6

0,20887

95,80976

Circulatory bath

29,88

20

597,6

0,204758

96,01016

Psychologist consultation

263,49

2

526,98

0,180561

96,37089

Cholesterol

18,78

28

525,84

0,180171

96,54747

Knee joint puncture

515,37

1

515,37

0,176583

96,71977

Colonoscopy

502,86

1

502,86

0,172297

96,88832

Cardiologist  consultation

81,99

6

491,94

0,168556

97,0504

Urine blood analysis

6,48

73

473,04

0,16208

97,21194

Water curative gymnastics

13,47

35

471,45

0,161535

97,36841

Blood C-reactive  albumen level examination

7,74

59

456,66

0,156467

97,52397

Lumbar spine segment massage

19,74

23

454,02

0,155563

97,67045

Foot vortical bath

42,75

10

427,5

0,146476

97,79873

Dermatologist-venereologist  consultation

124,8

3

374,4

0,128282

97,92386

Small pelvis organs ultrasonic scanning

121,74

3

365,22

0,125137

98,04267

Knee joint  arthroscopy

173,37

2

346,74

0,118805

98,15981

Red blood cells sedimentation speed determination

7,77

44

341,88

0,11714

98,27504

Urologist consultation

104,58

3

313,74

0,107498

98,48512

Lungs fluorography

74,85

4

299,4

0,102585

98,58339

Backbone relaxing massage

28,68

10

286,8

0,098268

98,67343

Darsonval exposure

26,28

10

262,8

0,090044

98,75783

Gastroenterologist consultation

82,11

3

246,33

0,084401

98,84056

Lower extremities vessels ultrasonic diagnostics

60,36

4

241,44

0,082726

98,92143

Abdominal cavity X-ray photography  

118,02

2

236,04

0,080875

98,99956

Lower leg massage

22,8

10

228

0,078121

99,07332

Picphloumetric

53,82

4

215,28

0,073762

99,14048

Knee joints ultrasonic scanning 

98,01

2

196,02

0,067163

99,20764

Ankle joints X-ray photography

98,01

2

196,02

0,067163

99,27366

Sinus appendages X-ray photography

192,66

1

192,66

0,066012

99,33081

Curative gymnastics

16,68

10

166,8

0,057151

99,38374

Stabilotraining

15,45

10

154,5

0,052937

99,43598

Pulmonologist consultation

76,23

2

152,46

0,052238

99,48716

Orthopedist consultation

149,37

1

149,37

0,051179

99,53721

Kidneys ultrasonic scanning

146,07

1

146,07

0,050049

99,58627

Otorhinolaryngologist consultation

143,19

1

143,19

0,049062

99,63274

Joints thermometry

135,63

1

135,63

0,046471

99,67297

Capnography

58,71

2

117,42

0,040232

99,71255

Backbone  loin X-ray photography

57,75

2

115,5

0,039574

99,74808

Ophthalmoscopy

103,71

1

103,71

0,035535

99,78252

Pulsoximetry

10,05

10

100,5

0,034435

99,81093

Specific antigen  determination 

20,73

4

82,92

0,028411

99,83901

Traumatologist   consultation

81,96

1

81,96

0,028082

99,86119

 Alkaline phosphatase determination

32,37

2

64,74

0,022182

99,88289

Triglyceride determination

63,33

1

63,33

0,021699

99,90236

Pneumotachometry

28,41

2

56,82

0,019468

99,91978

Determination  of the international normalized relation

50,85

1

50,85

0,017423

99,9369

Smear cytologic examination 

49,95

1

49,95

0,017115

99,95274

High density lipoprotein deternination

24,63

1

24,63

0,008439

99,96962

Low density lipoprotein deternination

24,63

1

24,63

0,008439

99,97727

Uric acid determination

22,35

1

22,35

0,007658

99,98417

Determination of antibody to C- hepatitis virus

20,13

1

20,13

0,006897

99,99735

Prothrombin time determination

18,33

1

18,33

0,00628

100

С-reactive albumen determination

 

7,74

1

7,74

0,002652

100

 

When doing analysis of  medical services ( physioprocedures, massage) influencing knee joint functions, it turned out  that in Almag-01device group   (n=75) there were  1901  rendered services, and in placebo device group (n=95) - 2070 ones (tab. 22). In Almag-01device group the average number of rendered procedures per patient  influencing knee joint functions came to 25,3 while in placebo device group the  average number of procedures  per patient amount to   to 21,7. So we see that in Almag-01device group average number of  carried out  procedures was 3,6  more  of those  in placebo device group.  

While carrying  out medical procedures , influencing affected joints functions,  quality analysis there were revealed the fact that in ALMAG-01 device the medical  procedures ( such as hydromassage,  accupuncture, iodide-bromine bath, Novocaine compress, water curative gymnastics,  knee joint magneto-therapy, knee joints massage, backbone massage, mechanotherapy, ozokerite therapy, knee joint dry heat)     had been carried out more frequently. But it is unlikely, that these differences  considerably exerted   examination  final results.

Table  22

The list of rendered  medical procedures

influencing knee joint function

 

Medical procedures

The number of   procedures rendered  in  ALMAG-01  device group  (n=75), абс. (%)

The number of   procedures rendered  in  placebo device group  (n=95), абс. (%)

Aerocryotherapy Аэрокриотерапия

5 (6,6%)

10 (10,5%)

Magnetic traveling pulsed field therapy

53 (70,6%)

84 (88,4%)

Sea salt bath

28 (37,3%)

50 (52,6%)

Backbone massage

28 (37,3%)

20 (21%)

Foot vortical bath

10 (13,3%)

10 (10,5%)

« Solux” lamp exposure

18 (24%)

0

Hydromassage

42 (56%)

10 (10,5%)

Darsonval exposure

10 (13,3%)

10 (10,5%)

Feet diodynamic currents

10 (13,3%)

0

Training apparatus physical exercises

0

20 (21%)

Acupuncture

68 (90,6%)

20 (21%)

Iodide-bromine bath

20 (26,6%)

0

Knee joint  medical bile compress

0

34 (35,7%)

Medical bile  night compress

10 (13,3%)

76 (80%)

Novocaine compress

50 (66,6%)

17 (17,8%)

Laser therapy

20 (26,6%)

30 (31,5%)

Water curative gymnastics

80 (106,6%)

35 (36,8%)

Individual curative gymnastics

5 (6,6%)

0

Group curative gymnastics

48 (64%)

10 (10,5%)

The physiotherapy exercises aimed to  left knee function  and mobility recovery

343 (457,3%)

836 (880%)

Curative swimming

20 (26,6%)

10 (10,5%)

Knee joint magneto-therapy

411 (548%)

407 (428,4%)

Massage

20 (26,6%)

70 (73,6%)

Head hair part massage

8 (10,6%)

0

Low leg massage

0

10 (10,5%)

Thorax massage

20 (26,6%)

20 (21%)

Knee joints massage

79 (105,3%)

20 (21%)

Backbone massage

40 (53,3%)

0

Backbone lumbar sacral part massage

61 (81,3%)

54 (56,8%)

Cervical collar area massage

54 (72%)

50 (52,6%)

Back relaxing massage

0

10 (10,5%)

Mechanic therapy

35 (46,6%)

0

Ozokerite therapy

18 (24%)

0

Back lumber part segment massage

10 (13,3%)

23 (24,2%)

Stabilo-training 

0

10 (10,5%)

Dry СО2 bath

0

20 (21%)

Knee joint dry heat

10 (13,3%)

25 (26,3%)

Joints thermo-therapy

0

1 (1%)

Physio-procedure 

185 (246,6%)

0

Medical phonophoresis

30 (40%)

40 (42,1%)

Glucocorticoid electrophoresis

20 (26,6%)

0

Procedures total number

1901

2070

Procedures average number per patient

25,3

21,7

In Almag-01device patient group medical procedures  expenses, from  public health system position ,    (n=75) came to 192 688, 98 rub. Medical services expenses per patient came to  2 569,18 rub.

In placebo – Almag-01 device  patient group medical procedures expenses, from  public health system position, (n=95) came to  275 240, 58 rub. Medical services expenses per patient came to 2 897, 26 rub.

Hotel services expenses per patient staying in hospital came to :

Ø for patient group applying  ALMAG-01  device : 176,17 rub. * 15,7 days  = 2 765,86 rub.

Ø for patient group applying placebo Almag-01 device : 176,17 rub. * 20,4 days = 3 593,86 rub.

Almag-01 device  applying group total expenses per patient came to:                              2 313 rub. + 2 569,18 rub. + 2 765,86 rub. = 7 648,04 rub.

Placebo Almag-01 device  applying group total expenses per patient came to: 3 113 rub. + 2 897,26 rub. + 3 593,86 rub. = 9 604,12 rub.

“Expenses-efficiency”analysis results are given in table 23. To make analysis  the “ Pain and discomfort related dynamic of severe  and moderate dysfunction  life quality” factor have been taken  because  sedative effect is  an important one in knee joints  osteoarthritis therapy and the application of Almag-01 device ,in this particular case,  proves  its   preferences regarding life quality effect as compared to  placebo-device application.  

Table  23

“Expenses-efficiency”analysis in connection with  “ dynamic of pain and discomfort related severe  and moderate dysfunction  life quality ” factor

 

Аlmag-01 device group                   (n = 75)

Placebo device group   

(n = 95)

Treatment total expenses  per patient                           rub.

7 648,04

9 604,12

“Dynamic of pain and discomfort related severe  and moderate dysfunction  life quality” factor,                       patients percent

0,57

0,37

Pain and discomfort  related  life quality moderate and severe  abnormalities  reduction                            «Expenses -profit »index,               rub.

 per patient

13 417

25 956

As it is seen from the table  Almag-01 magneto-therapy is an effective strategy  from the point of expenses for  carrying  out “expenses-efficiency”analysis according to “ dynamic of pain and discomfort related severe  and moderate dysfunction  life quality” factor.  Expenses in Almag-01 device group in this particular case (  reduction of pain and discomfort related severe  and moderate dysfunction  life quality per patient)   came  to   13 417 rub. per patient  that is practically twice less than  in placebo-device they were 25 956 rub. per patient for reaching the same effect .

Conclusion

Randomized, double-blind, placebo controllable  examination of magnetotherapy clinico -economic efficiency  with Almag-01device  application  for gonarthrosis has proved  its cost efficiency being included  in therapeutic process.

The most important differences  between groups of  Almag-01 device and placebo device  groups have been taken according the  indications  as follows:

-  «Pain and discomfort»  index (indication)  change  (questionnaire ЕQ-5D);

- joint size change (according to International classifier)

According to life quality dynamic being evaluated  under the ЕQ-5D questionnaire there was noted reduction of “ Pain and discomfort”  indication  (index)  in Almag-01 device group ( patients with moderate and severe diseases abnormalities )  by 57,3% ( from 96% to 38,7%) as compared to   37,9% (from 100% to 62,1%) in  placebo device group. According to K.A.. Litkina pain influence is one of the most important factors in arthrosis treatment.    

When analysing the affected join size  in Almag-01 device group it was noted the reduction of the joint  size by  3,9 sm. as compared with  placebo-device group - 2,9 sm.  Taking into account the joint size, joint  size change dynamic  testifies the more evident  therapy effect with Almag-01 device  application. Affected joint flexion(bending)/extension angle dynamic analysis manifested joint  mobility function change. In Almag-01 device group the bending angle was reduced   by 7,40 in average and in placebo Almag-01 device group the reduction was by 3,50.   This index testifies in general statistically  not great  increase of knee joint mobility function in Almag-01 device group though  in placebo device group the number of procedures (services) aimed to knee joint function recovery and mobility was 2,44 times more than those in Almag-01 device group

An estimation of affected joints functional parameters dynamics  estimated according to  the International qualifier has  shown  results as follows:

- according to  «Slight abnormalities and their absence” parameter in Almag-01 device group as compared to placebo-device group there was noted the more evident   positive dynamic of  joint mobility function (21,3% and  9,5%, accordingly).     

- placebo Almag-01 device group there was noted  the reduction of patients number with severe and moderate 1km walking parameter abnormalities  (from  69,4% to 46,3%) and the increase of patient number with slight abnormalities   according the same parameter  (from  10,5% to 31,6%).

- the evident more number of patients with slight  abnormalities  or  their  absence according to “Short-distance walk” in Almag-01 device group as  compared  to placebo-device group (14,6% and 4,2% accordingly).

So the analysis of affected joint functional parameters evaluated according to  International classifier and with a help of objective parameters ( joint size, flexion/extension angle) noted statistically evident differences  in Almag-01 device  and placebo-device groups. But it should be taken in account that  treatment average  time in groups ( Almag-01 device  and placebo-device groups) was 13 and 10 days  accordingly and  didn`t allow to change joint`s functional characteristics greatly  for  such short period of time.

The effect of nonsteroidal anti-inflammatory medications and additional physio-procedures on joints characteristics and possibility of  Almag-01 device effect  overestimation have been studied.  

Analysis of nonsteroidal anti-inflammatory medications application showed  that the preparation of this group was prescribed  1,97 time more in placebo-device  group as compared to Almag-01device group.   

Analysis of different services as physiotherapy procedures application frequency showed that the last were prescribed 3,6 procedure more per patient  in Almag-01 device group( 25,3 procedures per patient)  than in placebo-device group ( 21,7 procedures per patient) .

Expenses analysis showed that in Almag-01 device group there was expended  the sum of 7 648 rub per patient while in placebo-device group the sum was 9 604 rub.

« Expenses - efficiency” analysis showed that magneto therapy procedure with Almag-01 device was the effective strategy  from the point of expenses according pain and discomfort related  parameters of life quality severe and  moderate abnormalities dynamic. So applying Almag-01 device to reduce life quality moderate and severe abnormalities in connection to pain and discomfort   it was required to spend 13 417 rub. per patient that is 1,93 times less than with the application of  placebo-device. (  25 956 rub per patient to achieve  to  the same effect).

Examination restrictions are group incomparability  ( according to average age, the quality of life affected joints functional characteristics ) and significant differences  in medical  treatment course in two groups ( frequency of  both nonsteroidal anti-inflammatory medications and physiotherapeutic procedures   administration in placebo-device group; the big frequency of medical procedures adminisration, including magnetotherapy in  Almag-01 device group). 

CONCLUSIONS

Carried out randomized, double - blind, placebo controllable  examination of magnetotherapy clinico -economic efficiency  with Almag-01device electro-magnetic exposure  (frequency - 6,24 Hz,  a magnetic field intensity -20 mTl ) in gonarthrosis treament  identified  its clinico-economic efficiency. Its influence on life quality characteristics in connection with pain and discomfort is the most evident  one.

Strategy of traveling  pulsed magnetic field  introduction into medical process is an efficient one  from a point of expenses while carrying  the  "expense - efficiency" analysis out according to  life quality  severe  and moderate abnormalities dynamics criterion in connection with  pain and discomfort ( "expenses - profit " effect index   is  13417 rub. per  patient as compared  with expenses equal to 25956 rub. for the  achievement of the same  effect per  patient in placebo device group) .

It is required to carry our more extensive examination of  administrated  both physio-therapeutic procedures number and denomination and nonsteroidal anti-inflammatory medications to make magneto therapy effect on joints functional characteristics  assessment.

Literature reference list

1.ОСТ «Clinical-economic study. General guidelines » (RF PH No. 163 of  27.05.02).

2.P. A. Vorobjev, M. V. Avksentjeva  .... Clinical-economic analysis  - М.:Njudiamed. – 2008.

3.K. A. Litkina , L.V. Sidorova., P. A. Vorobjev, M. V. Avksentjeva, V.V. Tsurko  Patients suffering from osteoarthrosis life quality. Problems of standardization in public health services. 2006. - No.6. – С. 12-27.

4.V. N Amirdzhanova, G. M. Kojlubaeva // Sientific- practical  rheumatology  — 2003. — № 2. — С. 72—76.

5.Сизова Л. В. // Научно-практическая ревматология. — 2000. — № 2. — С. 38—42.

6.Anderson R. T., Aaronson N. K., Wilkin D. // Qual. Life Res. — 1993. — 2. — P. 369—395.

7.Bowling A. Measuring disease. A review of disease-specific quality of life measurement scales. — Philadelphia: Open University Press, 1996.

8.Kind P. // Quality of Life and Pharmaco-economics in Clinical Trials. 2th ed. / Ed. Spiker. — Philadelphia: Lippincott — Raven Publishers, 1996. — P. 191—201.

9.Laxafoss E, Jacobsen S, Gosvig KK, Sonne-Holm S. Case definitions of knee osteoarthritis in 4,151 unselected subjects: relevance for epidemiological studies : The Copenhagen Osteoarthritis Study. Skeletal Radiol. 2010 Jan 30. [Epub ahead of print]

10.Toivanen AT, Heliövaara M, Impivaara O, Arokoski JP, Knekt P, Lauren H, Kröger H. Obesity, physically demanding work and traumatic knee injury are major risk factors for knee osteoarthritis--a population-based study with a follow-up of 22 years. Rheumatology (Oxford). 2010 Feb;49(2):308-14.

11.Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33.

12.Roux CH, Saraux A, Mazieres B, Pouchot J, Morvan J, Fautrel B, Testa J,Fardellone P, Rat AC, Coste J, Guillemin F, Euller-Ziegler L; KHOALA Osteoarthritis Group. Screening for hip and knee osteoarthritis in the general population: predictive value of a questionnaire and prevalence estimates. Ann Rheum Dis. 2008 Oct;67(10):1406-11.

13.Gosvig KK, Jacobsen S, Sonne-Holm S, Palm H, Troelsen A. Prevalence of malformations of the hip joint and their relationship to sex, groin pain, and risk of osteoarthritis: a population-based survey. J Bone Joint Surg Am. 2010 May;92(5):1162-9.

14.Dagenais S, Garbedian S, Wai EK. Systematic review of the prevalence of radiographic primary hip osteoarthritis. Clin Orthop Relat Res. 2009 Mar;467(3):623-37.

15.Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7.

16.Bieleman HJ, Oosterveld FG, Oostveen JC, Reneman MF, Groothoff JW. Work participation and health status in early osteoarthritis of the hip and/or knee: a comparison between the Cohort Hip and Cohort Knee and the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2010 May;62(5):683-9.

Appendix  1

 

“  PHARMACOLOGY -ECONOMIC  RESEARCH SOCIETY ”

INTER-REGIONAL PUBLIC ORGANIZATION

 

 

 

Examination  card No.        

 

 

Examination date _______________________________ ____________________

 

City/town__ ________________________________________________________

 

Medical prophylactic establishment_________________________________________________________________________________________________________________________________________________________________________________________________

 

 

 

 

PATIENT WITH OSTEOARTHRITIS  

CLINICAL EXAMINATION CARD  No.

DOCTOR  ______________________________________________________

                                   ( full name )

 

 

 

 

 

 

 

DEVICE RANDOMIZATION  TAKEN RESULTS :

 

АЛМАГ-01

 

PLACEBO

(check the required device )

 

THE FORT OF PATIENT CONSENT  TO  EXAMINATION PARTICIPATION

 

This is to certify my free-will consent to take part  in “ Almag-01 clinical-economic  examination for patients suffering from   rheumatoid arthritis “  carried out by“  Pharmacology -Economic Research Society  ” Inter- Regional Public Organization.

 

Hereby I prove  my notification  of the facts as  follows :

·        the purpose of examination is to make magneto-therapy application (for rheumatoid arthritis  treatment )  economic  calculation 

·        participation in examination  does not cause  any risk and side effect .

·          guarantee to terminate participation in examination  any time I like

·        confidentiality of  information  is guaranteed by examination organizers  and the attending physician.

Patient (full name)  

Date Дата

Signature

 

 

The date of first examination   __________

 

Patient name _______________

 

Sex: male; female    

 

Age ______________

 

Main clinical diagnosis ________________________________________________

____________________________________________________________________

Complication ________________________________________________________ ____________________________________________________________________

Concomitant diagnosis _________________________________________________ ____________________________________________________________________

 

MAGNETO-SENSITIVITY :

Low

Mean

High  

 

 

 

The date of the patient next reception _____________________________________

Examination results____________________________________________________ ____________________________________________________________________________________________________________________________________________________________________________________________________________

 

ESTIMATION SCALES .

ORGANISM FUNCTION :

NO abnormalities  ( no one, not available, little ,...)    0-4%

SLIGHT abnormalities (small, week ,..)                        5-24%

MEAN abnormalities  ( mean, significant ,..)              25-49%

SEVERE abnormalities  (high-grade, intensive ,...)    50-95%

ABSOLUTE ABNORMALITIES  (full,...)               96-100%

 

Joint mobility functions

-under  examination :  backbone, shoulder, elbow, wrist, hip, knee,   mobility function, talocrural single or several  joints , hands and feet little joints; general joints  mobility; abnormalities as   joints excessive  mobility, joints, shoulders stiffness, arthritis.

-out of examination : joint stability, arbitrary functions control

 

Function name

Evidence of functional  abnormalities

No  abnormalities

Slight abnormalities

Mean abnor- malities

Severe  abnormalities  

Absolute

abnorm.

Several joints mobility.

More than one joints function volume and mobility freedom    

 

 

 

 

 

Joints overall mobility Whole body function volume and mobility freedom

 

 

 

 

 

 

Joint stability functions

Joint integrity support function

-under  examination: single and  several  joints stability function, joints general  stability ; abnormalities as shoulder joint instability, joints or hip.

-out of examination : joints mobility functions .

Function name

 Functional  abnormalities significance

No  abnormalities

Slight abnormalities

Mean abnor- malities

Severe  abnormalities  

Absolute

abnorm.

Several  joints stability . Joints integrity support function

 

 

 

 

 

Joints general  stability Whole body joints integrity support function

 

 

 

 

 

 

 

 

Walking and movement

The movement over the  surface on foot, step by step so that one foot    touches  the  surface, for example, walking,  walking ahead, walking back, walking aside   

- under examination: short or long distance walk; walking over the different surfaces; walking around  the obstacles .

- out of examination: body movement, movement by the ways different from walking  .

Function name

Functional  abnormalities significance

No  abnormalities

Slight abnormalities

Mean abnor- malities

Severe  abnormalities  

Absolute

abnorm.

Short distance walking.

One km or less walking , for example, in rooms, corridors , house,  or   short distance walk   outside.

 

 

 

 

 

Long  distance walking.

Walking for the distance more than 1 km. , for example, from one part of the village or town to the other, between villages or any outside  walking

 

 

 

 

 

 

 

UNDESIRABLE  FACTORS (EVENTS) EVALUATION  ACCORDING TO  NARANSHO SCALE (check the required answer )

1.Whether there were an earlier evident  messages on this reaction. Yes - 1, No - 0, don`t know - 0.

2. Whether there was a reaction after suspected medicine introduction . Yes - 2, No - 1, don`t know  - 0.

3. Whether there was any  improvement of  patient state  after both  medicine or  specific antagonist introduction termination. Yes  - 1, No - 0, don`t know  - 0.

4.Whether there was  any side reaction re-occurrence after medicine   repeated  introduction.  Yes - 2, No - –1, don`t know  - 0.

5. Whether there were any reasons  (beside medicine)  causing the reaction.  Yes - –1, No-  0,  don`t know - 0.

6. Whether there was re-occurrence of any reaction applying placebo device Yes - – 1, No - 1, don`t know  - 0.

7. Whether there was medicine in the blood (or any other liquids) in the concentrations considered as a toxic ones? Yes  - 1, No — 0, don`t know - 0.

8. Whether the reaction was  more severe after increase of the dose and  less severe after its decrease ? Yes - 1,No — 1, don`t know - 0.

9. Whether there was the same reaction of the patient to the same or similar medicine when the medicine was taken earlier. Yes-1,No-0, don`t know - 0.

10. Whether the side reaction had the evident  prove. Yes  - 1, No - 0, don`t know - 0.

 

When the  points amount is 9 it is possible to speak about the definite relations , 5-8 — potential , 1 -4 — possible , 0 — doubtful

 

This questionnaire EQ-5D is filled in by the patient  himself

 

 

 

 

Questionnaire EQ-5D

 

The purpose of this questionnaire  is to study both  patients and healthy people life quality

 

This questionnaire is aimed to reveal the attitude to your own health. It is presented  in the form of your health state list. There are no right or wrong answers in relation to your health  state, we are interested only in your personal opinion;.First  of all we ask you to assess your state of health up to the present.

 

Below there is 5 questions in relation to your health state. Giving an answer you should check up one item.

 

Moving in space

 

Ø I have no problems with moving in space

Ø I have some problems with moving in space

Ø I am bedridden

 

Self-service

c I have no problem with self-service  

c I have some problems with washing and dressing

c I can`t  wash and dress myself

 

Daily routine

 

c I have no problems with daily routine to do  (work, study, household activity , leisure)

c I have some problems with household daily routine

c I can`t do household daily routine

 

Pain and discomfort

 

c I don`t feel any  pain and discomfort.

c I have the slight sensation of pain and discomfort.

c I suffer from pain and discomfort.

 

Anxiety and depression

 

·         I don`t feel any sensation of anxiety and depression.

·         I have the slight sensation of anxiety and depression.


·         I have the sensation of high-grade anxiety and depression.


 

Your today health state as compared to  those year ago :

 

·         It is much better

·         The same

·         It becomes worse

 

In order to estimate you state of health there is a scale like thermometer according to which the best sate of health is estimated   with 100 points  and the worse one with 0.

Please mark your state of health  on the thermometer according to your sensations.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The date  of examination______________________________________________

 

The name of the patient _______________________________________________

 

Sex: Мail   Femail

Age  (full years of age) ______________________________________________

 

 

EXAMINATION LABORATORY METHOD WITHIN  21 DAYS

 

Examination type

Number per course of treatment

 

Blood clinical analysis

 

 

Hemoglobin, leukocytes

 

 

Bilirubin blood analysis

 

 

Rothrombin blood analysis

 

 

Blood glucose.

 

 

AST,ALT blood analysis

 

 

Kreatine blood analysis

 

 

Urine blood analysis

 

 

C-reactive protein level blood examination

 

 

General protein blood analysis   

 

 

General protein and protein  fraction blood analysis

 

 

Coagulougram

 

 

Blood electrolyte

 

 

Group and Rhesus factor - blood factor

 

 

Urine general analysis

 

 

Others :

 

 

 

EXAMINATION INSTRUMENTAL METHOD WITHIN  21 DAYS

Examination type

Number per course of treatment

Heartbeats  rate  measurement

 

Pulse examination

 

Peripheral arterial pressure  measurement  артериях

 

Others:

 

 

 

 

 

 

 

 

 

EXPERTS CONSULTATIONS  WITHIN 21 DAYS

Expert name

Number per course of treatment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PRESCRIBED PHARMACOTHERAPY ( the 21first  examination day )

( List of all prescribed medication including  medical solutions used for dissolution)

 

Medication name

Dose

Per  procedure

Dose

Per day

Number per  day

Proce-dure means 

Course of treat-ment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

THERAPY AND  PATIENT CARE PROCEDURES

Number per course of treatment

 

 

 

 

 

 

 

 

 

 

 

 

 

THERAPY AFTEREFFECTS

SIDE EFFECTS ,UNDESIRABLE PHENOMENON .

1.Whether there were any side, undesirable effect ?

Yes              No               It is not known

 

If “YES” answer is marked , note the following: name, date, severity ( light, mean, strong), the  cause of  side effect development , taken measures

1 __________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

2__________________________________________________________________________

  __________________________________________________________________________

  __________________________________________________________________________

3__________________________________________________________________________

  __________________________________________________________________________

  __________________________________________________________________________

4__________________________________________________________________________

  __________________________________________________________________________

  __________________________________________________________________________

5__________________________________________________________________________

  __________________________________________________________________________

  __________________________________________________________________________

The date of form filling -____________________________________________________

Expert  signature _______________________________________

 

Has Undergone  in-patient treatment :   yes    no  ( treatment  duration)  ______________

Temporary invalidity :  ( duration, dates )__________________________

 

Remarks and  additions ________________________________________________________________________________________________________________________________________________________________

 

 

 

 

 

 

.

 

Back to the list

Follow us

share it

8