Efectele Terapiei Cu Camp Magnetic Pulsatil La Pacientii Cu Gonartroza

8/12/2019 Efectele Terapiei Cu Camp Magnetic Pulsatil La Pacientii Cu Gonartroza

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UNIVERSITATEA DE MEDICIN I FARMACIE

IULIU HAIEGANU CLUJ-NAPOCA

Efectele terapiei cu cmp magnetic pulsatil la pacienii cu

gonartroz

- Rezumatul tezei de doctorat -

Doctorand: Ionu-Mihai Moldovan

Conductor doctorat: Liviu Vladimir Pop

CLUJ-NAPOCA2012


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CUPRINS

INTRODUCERE 13

STADIUL ACTUAL AL CUNOATERII1. Electromagnetismul 17

1.1 Introducere 171.2 Istoric 18

1.3 Istoricul utilizrii elctromagnetismului n medicin 20

2. Fizica electromagnetismului 23

2.1. Magneii permaneni 23

2.2. Cmpul magnetic produs de curentul electric liniar 24

3. Electromagnetismul, de la fizic la biofizic 273.1. Clasficarea undelor electromagnetice 273.2. Mecanismele de aciune ale cmpului magnetic pulsatil asupra esuturilorbiologice

28

3.3. Efectele cmpului magnetic pulsatil asupra esutului osos 29

3.4. Efectele cmpului magnetic pulsatil asupra cartilajului articular 303.4.1. Efectele in vitro i ex vivo ale cmpului magnetic pulsatilasupra cartilajelor articulare

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3.4.2. Studiile clinice ale terapiei cu cmp magnetic pulsatil lapacienii cu artroz

31

CONTRIBUIA PERSONAL1. Ipoteza de lucru 37

2. Metodologie general 39

3. Studiul 1 Efectele cmpului magnetic pulsatil asupraproprietilor electrice ale proteinelor din lichidul articular

41

3.1. Introducere 41

3.2. Ipoteza de lucru 423.3. Material i metod 42

3.4. Rezultate 42

3.5. Discuii 47

3.6. Concluzii 49

4. Studiul 2 Efectele structurale ale terapiei cu cmp magneticcontinuu i pulsatil asupra explantelor articulare umane

51

4.1. Introducere 51

4.2. Ipoteza de lucru 52

4.3. Material i metod 52

4.3.1. Prelevarea cartilajelor 52

4.3.2. Tratamentul cartilajelor 534.3.3 Procesarea esuturilor 53

4.3.4. Procedura de examinare 53

4.3.5. Prelucrarea statistic a rezultatelor 54

4.4. Rezultate 54

4.5. Discuii 60

4.6. Concluzii 62


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5. Studiul 3 - Efectele terapiei cu cmp magnetic pulsatil focalizat

la pacienii cu gonartroz, un studiu randomizat, controlat prinplacebo

63

5.1. Introducere 63

5.2. Ipoteza de lucru 63

5.3. Material i metod 635.3.1. Loturi 63

5.3.2. Variabile 64

5.3.3. Criterii de includere n studiu 65

5.3.4. Criterii de excludere din studiu 65

5.3.5. Prelucrarea statistic a rezultatelor 65

5.4. Rezultate 66

5.4.1. Caracteristicile loturilor studiate 66

5.4.2. Evoluia parametrilor studiai n lotul placebo 71

5.4.3. Evoluia parametrilor studiai nlotul activ 75

5.4.4. Evoluia comparativ a parametrilor studiai ntre cele dou loturi 78

5.4.5. Modificrile parametrilor studiai n cele dou subloturi(fr stadiileKellgren III i IV)

82

5.4.5.1. Modificrile parametrilor studiai n sublotul placebo 82

5.4.5.2. Modificrile parametrilor studiai n sublotul activ 855.4.5.3. Evoluia comparativ a parametrilor studiai n cele dou

subloturi88

5.4.6. Efectele terapiei cu cmp magnetic pulsatil asupra valorilor tensiuniiarteriale.

92

5.4.7. Efectele adverse ale terapiei cu cmp magnetic pulsatil focalizat 92

5.5. Discuii 93

5.6. Concluzii 94

6. Concluzii generale 95

7. Originalitatea i contribuiile inovative ale tezei 97REFERINE 99

ANEXA 1 - Fia de urmrire a pacientului cu gonartroz 109ANEXA 2 Scorul histologic i histochimic Mankin modificat 115

CUVINTE CHEIE: cmp magnetic pulsatil, gonartroz, cartilaj articular, studiu clinic orbrandomizat controlat placebo

REZUMAT

Electromagnetismul este n fizica modern una din cele patru interaciunifundamentale ale Universului, alturi de interaciunea slab, interaciunea puternic igravitaia. Dei magnetismuli electricitatea au fost iniial observate i studiate separat, elesunt contopite azi ntr-o singur for deoarece reprezint forme de manifestare aleaceleiai particule fundamentale: electronul.


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Terapia cu cmp magnetic pulsatil a fost aprobat n 1979 de ctre Agenia naionala medicamentelor i dispozitivelor medicale din Statele Unite ale Americii (FDA) n terapiapseudartrozelor i a fracturilor neconsolidate. De atunci, metoda a fost testat nnumeroase patologii precum cele ale sistemului nervos central, musculoscheletal iosteoarticular, n boli endocrine i oncologice.

Interesul fa de efectele terapiei cu cmp magnetic pulsatil(CMP) n boala artroziceste n continu cretere. Acest lucru se datoreaz n primul rnd eficieneinesatisfctoare aterapiilor medicamentoase n aceast patologie. n plus, terapia cu CMPprezint un profil de siguran foarte bun i proprietile unui modificator de boal npatologia artrozic: inhib apoptoza condrocitelor, stimuleaz proliferarea condrocitelor,

stimuleaz sinteza matricei extracelulare, inhib IL 1(molecul cu efect catabolic asupra

cartilajului articular) i stimuleaz sinteza TGF (molecul cu efect anabolic asupracartilajului articular), efecte dovedite n studii experimentale in vitro sau ex vivo.

Prezenta tez de doctorat include un numr de trei studii experimentale. Primul

studiu urmrete s identifice unposibil mecanism de aciune alterapiei cu cmp mangeticpulsatil, i anume modificarea proprietilor electrice ale proteinelor expuse n CMP.

Al doilea studiu urmrete modificrile morfopatologice ale terapiei cu cmpmagnetic continuu(CMC) i CMP asupra explantelor cartilaginoase umane, provenite de lapacieni care au beneficiat de artroplastie total de old.

Cel de-al treilea experiment, mai relevant din punct de vedere clinic, este un studiuorb, randomizat, controlat prin placebo, care urmrete efectele terapiei cu cmp magneticpulsatil asupra durerii i asupra parametrilor algo-funcionali rezultai din chestionarulWestern Ontario and McMaster Universities Osteoarthritis (WOMAC) la pacienii cu gonartroz

bilateral primar, cu rspuns nesatisfctorla terapia cronic cu antiinflamatoare nesteroidiene.Studiul 1 - Efectele cmpului magnetic pulsatil (CMP) asupra proprietilor

electrice ale proteinelor din lichidul articular.

Ipoteza de lucru

Studiul de fa i propune s studieze efectele CMP asupra proteinelor din lichidularticular prin analiza electroforetic a acestuia nainte i dup expunerea n CMP.

Material i metodZece artrocenteze au fost efectuate la 8 pacieni cu gonartroz reacionat i 2

pacieni cu spondilartropatie seronegativ. Lichidul articular al fiecrui pacient a fostintrodus n dou vacutainere. Primul a fost trimis la laborator, unde s-a fcut analiza

electroforetic a proteinelor, iar al doilea a fost expus n cmp magnetic pulsatil focalizat lao intensitate de 300 Gauss i o frecven de 1,5 Hz timp de 60 de minute, dup care s-arealizat electroforeza proteinelor din lichidul articular.

Rezultate

Expunerea n cmp magnetic pulsatil nu a modificat proprietile electrice aleproteinelor din lichidul articular la ncheierea expunerii, valorile celor dou loturi fiindfoarte apropiate i nediferite semnificativ din punct de vedere statistic(p>0,05).


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n lichidul articular al pacienilor cu gonartroz s-au identificat dou fraciuniproteice (albumine i alfa-1 globuline), n timp ce n lichidul articular al pacienilor cuspondilartropatie seronegativ s-au identificat 3 fraciuni proteice (albumine, alfa-1globuline i alfa-2 globuline).

Analiznd variaia concentraiei de albumine din lichidul articular cu durata bolii cuajutorul dreptei de regresie a lui Pearson, am remarcat existena unei bune relaii liniarentre aceti doi parametri (indice de determinare R2=0,74). Astfel, cu ct durata bolii estemai mare, cu att concentraia de albumineste mai mare.

In mod similar, cu ct durata medie a bolii a fost mai mic, cu att concentraia dealfa-1 globuline din lichidul articular a fost mai mare (indice de determinare R2=0,71).

La analiza regresiei multiple, folosind ca variabil dependent procentul de albuminedin lichidul articular, iar ca variabile independente durata bolii i vrsta pacienilor, amconstatat o variaie semnificativ statistic (p=0,008) a procentrului de albumine doar cudurata bolii nu i cu vrsta pacienilor.

Studiul 2 - Efectele structurale ale terapiei cu cmp magnetic continuu ipulsatil asupra explantelor articulare umane.

Ipoteza de lucru

Studiul de fa i propune s studieze modificrile morfologice ale cmpuluimagnetic pulsatil i continuu asupra explantelor articulare provenite la pacieni cucoxartroz care au beneficiat de artroplastie total de old.

Material i metodZece cartilaje articulare de la nivelul capului femural au fost obinute de la pacieni

care au beneficiat de artroplastie total de old. Cartilajul articular de la nivelul zoneineportante a capului femural, cu aspectul macroscopic cel mai bun a fost detaat prinseciune tangenial la suprafaa osului. Apoi, piesa de cartilaj a fost fragmentat n 4 priegale i transferat n patru recipiente sterile coninnd 10ml mediu DMEM(Dulbeccos

Modified Eagle Medium)(Lonza), Penicilin 100UI/ml i Streptomicin 100g/ml (Lonza).Un prim fragment (lot iniial) a fost trimis n mai puin de 36 de ore la laboratorul deAnatomie patologic al Spitalului CF Cluj-Napoca, unde s-a practicat coloraia safraninorange. Celelalte trei fragmente au fost incubate n mai puin de 6 ore de la operaie, la370C timp de 4 zile.

Fragmentul al doilea a fost utilizat drept martor(lot control), fragmentul al treilea afost tratat cu cmp magnetic continuu (lot CMC) la o intensitate 0,1 mT timp de 3 ore pe zi,

iar al patrulea (lot CMP) cu cmp magnetic pulsatil cu frecvena de 1,5Hz i intensitatea de30 mT timp de trei ore pe zi. Dup patru zile, cele trei fragmente au fost i ele analizatehistochimic prin coloraia safranin orange.

Evaluarea histologic i histochimic a cartilajelor a fost fcut de doi observatoriindependeni folosind scorul Mankin modificat. n acest sistem de gradare al cartilajuluiartrozic, 0-6 puncte sunt atribuite leziunilor matricei extracelulare, 0-3 puncte anomaliilor


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condrocitare, 0-4 puncte scderii progresivea intensitaii coloraiei safranin-orange i 0-1puncte pentru pierderea integritii bordurii osteo-cartilaginoase.

Rezultate

Scorul Mankin modificat n lotul de control s-a agravat fa de cel iniial (9,5 vs 8,95).

n lotul tratat cu cmp magnetic continuu acesta a avut valori mai reduse fa de lotulcontrol (9,05), iar n lotul tratat cu cmp magnetic pulsatil scorul Mankin modificat a avutvalori mai mici chiar fa de lotul iniial(8,7). Cu toate acestea, diferenele nregistrate ntreloturi nu au fost semnificative din punct de vedere statistic, valoarea cea mai mic aprobabilitii nregistrndu-se la compararea lotului control cu lotul tratat cu cmpmagnetic pulsatil (p=0,27).

Variaiile scorului Mankin modificat n cele patru loturi s-a realizat n special peseama modificrii subscorului colorare safranin orange. n lotul de control acesta s-aagravat fa de cel iniial (2,95 vs 2,5). n lotul tratat cu cmp magnetic continuu subscorul

colorare safranin orange a avut valori mai reduse fa lotul control (2,65) iar n lotul tratatcu cmp magnetic pulsatil acesta a avut valori mai mici chiar fa de lotul iniial(2,45). Cutoate acestea, diferenele nregistrate ntre loturi nu au fost semnificative din punct devedere statistic, valoarea cea mai mic a probabilitii nregistrndu-se la compararealotului control cu lotul tratat cu cmp magnetic pulsatil (p=0,14), respectiv la compararealotului iniial cu cel control(p=0,17).

Studiul 3 - Efectele terapiei cu cmp magnetic pulsatil focalizat la pacienii cugonartroz,un studiu randomizat, controlat prin placebo.

Ipoteza de lucru

Studiul de fa i propune s studieze efectele cmpului magnetic pulsatil focalizat

(CMPF) de joas frecven(1,5 Hz) i medie intensitate (30 mT) la pacienii cu gonartrozbilateral primar, cu un scor radiologic Kellgren-Lawrence 1 i o scal analog vizual a

durerii 4, n ciuda consumului cronic de antiinflamatoare nesteroidiene icondroprotectoare.

Material i metodUn numr 70 de pacieni consecutivi diagnosticai cu gonartroz bilateral primar au

fost randomizai n dou loturi: unul activ i unul placebo n raport de 1:1. Pacienii dinlotul placebo au beneficiat de terapie local cu ultrasunete (0,5W/cm2), peloidoterapielocal (nmol de Techirghiol), i o form de cmp magnetic continuu similar ca intensitate

cu cmpul magnetic terestru, timp de 15 minute pe zi. Lotul activ a beneficiat de tratamentlocal cu ultrasunete(0,5W/cm2), peloidoterapie local i terapie cu cmp magnetic pulsatilfocalizat la o frecven de 1,5 Hz i o intensitate de 300 Gauss(30 mT) timp de 15 minutepe zi. Durata tratamentului n ambele loturi a fost de 10 zile. Fiecrui pacient i s-anregistrat zilnic tensiunea arterial nainte i dup ncheierea terapiei cu cmp magneticpulsatil focalizat. Deasemenea, pacienii au completat i informaii referitoare la reaciile


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adverse pe care le-au resimit de-a lungul terapiei cu cmp magnetic pulsatil focalizat(CMPF).

n sudiu au fost inclui pacieni cu simptomatologie clinic de gonartroz bilateralprimar, conform criteiilor Colegiului American de Reumatologie, cu modificri radiologicepe scala Kellgren-Lawrence(1), cu un scor mai mare sau egal cu 4 pe scala analog vizual adurerii(SAV). Au fost exclui din studiu pacieni cu gonartroz secundar, cu implantemetalice, cu implant de pacemaker, cu infecii locale sau generale, cu tumori locale sau ladistan, cu diateze hemoragice recente (n ultimul an) i pacieni cu insuficiena cardiac,hepatic sau renal.

Rezultate

Din totalul celor 70 de pacieni inclui, 65 au ncheiat studiul (32 din lotul activ i 33din lotul placebo). La finalul celor 10 zile de tratament, n ambele loturi s-a constatat ombuntire semnificativ a scalei analog vizuale (SAV) a durerii i a scorului WOMAC fa

de evaluarea iniial (p0,05). Nu s-a constatat o mbuntire semnificativ statistic a

celor doi parametri n lotul activ fa de cel placebo (p0,05). n schimb, la o analiz asubloturilor, dup excluderea pacienilor cu gonartroz avansat, cu scor radiologicKellgren-Lawrence 3 i 4, pacienii care au beneficiat de tratament cu CMP au avut o

ameliorare superioar a SAV a durerii i a scorului WOMAC (p0,05).Tensiunea arterial a pacienilor din ambele loturi nu a fost semnificativ diferit la

finalul procedurilor fa de cea de la debut.Frecvena reaciilor adverse raportate de pacienii inclui n studiu a fost de 9% n

ambele loturi. Fenomenul de agravare temporar a durerii a fost resimit de ctre doipacieni din lotul placebo (6%) i de ctre doi pacieni din lotul activ (6%). Accentuarea

durerii a fost prezentn prima parte a tratamentului i nu a necesitat ntruperea acestuia.Concluzii generale1. Cmpul magnetic pulsatil de joas frecven i medie intensitate nu a modificat

proprietile electrice ale proteinelor din lichidul articular dup ncetareaexpunerii.

2. Procentul albuminelor din lichidul articular al pacienilor cu gonartroz ispondilartropatie seronegativ s-a corelat liniar cu durata bolii articulare n timpce procentul alfa1 globulinelor a prezentat o corelaie invers cu durata boliiarticulare.

3. Electroforeza proteinelor din lichidul articular este o metod promitoare, cost-eficient i accesibil, care poate oferi informaii despre durata boliiarticulare, intensitatea inflamaiei intra-articulare i poate orienta diagnosticulclinic n direcia unui reumatism degenerativ respectiv a unui reumatisminflamator, ns studii suplimentare sunt necesare n acest sens.

4. Expunerea explantelor articulare umane timp de 3 ore pe zi, pe o perioad de 4zile n cmp magnetic continuu de joas intensitate (0,1mT), respectiv n cmpmagnetic pulsatil de joas frecven (1,5 Hz) i medie intensitate (30mT) nu a


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determinat modificri semnificative ale scorului Mankin modificat la analizahistologic a cartilajelor prin coloraia safranin-orange.

5. Cu toate acestea, o tendin de ameliorare a scorului Mankin modificat s-aconstatat n lotul tratat cu cmp magnetic pulsatil fa de cel de control, pe seamacreterii intensitii colorrii safranin orange la nivelul matricei pericelulare iteritoriale ale cartilajelor articulare.

6. Fizioterapia cu ultrasunete i peloizi a fost eficient n reducerea durerii i ascorului WOMAC la pacienii cu gonartroz, cu scor radiologic Kellgren - Lawrence

1, cu o scal analog vizual a durerii 4 i cu rspuns nesatisfctor la terapia cuantiinflamatoare nesteroidiene i condroprotectoare.

7. Terapia cu cmp magnetic pulsatil focalizat, de joas frecven (1,5 Hz) i medieintensitate (30 mT), a adus beneficii suplimentare fa de aceste terapii, sczndsemnificativ durerea i scorul WOMAC la pacienii cu gonartroz incipient imoderat (stadiul radiologic Kellgren-Lawrence 1 i 2).

8. Terapia cu cmp magnetic pulsatil focalizat nu a modificat semnificativ valoriletensiunii arteriale.

9. Terapia cu cmp magnetic pulsatil focalizat, de joas frecven (1,5 Hz) i medieintensitate (30 mT) a fost bine tolerat i nu a prezentat efecte adverse notabile.


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IULIU HAIEGANU UNIVERSITY OF MEDICINE AND PHARMACY CLUJ-NAPOCA

The Effects of Pulsed Electromagnetic Field Therapy in Patients with

Knee Osteoarthritis

- Abstract of the doctoral thesis -

Doctoral student: Ionu-Mihai Moldovan

Scientific advisor: Liviu Vladimir Pop

CLUJ-NAPOCA2012


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magnetism and electricity were separately observed and studied, they are now consideredto be one single force because they represent forms of manifestation of the same particle:the electron.

Pulsed electromagnetic field therapy was approved by the Food and DrugAdministration in United States in 1979 for the treatment of non-union fractures andpseudarthrosis. Afterwards, the method has been tested in the treatment of severaldiseases, such as central nervous system, musculoskeletal, osteoarticular, endocrine andoncologic diseases.

The interest in the effects of pulsed electromagnetic field (PEMF) therapy indegenerative cartilage disease is continuously growing. This is caused by the insatisfactoryefficacy of the drug therapy in this disorder. Moreover, PEMF therapy has shown a goodsafety profile and properties of a disease modifying treatment in osteoarthritis by:inhibiting chondrocyte apoptosis, stimulating chondrocyte proliferation, stimulating

extracellular matrix synthesis, inhibiting the IL 1(molecule with a catabolic effect on the

articular cartilage) and stimulating the TGF (with anabolic effect on the articularcartilage). These effects were shown in experimental in vitro and ex vivo studies.

The present doctoral thesis includes three experimental studies. The first study aimedto identify the alteration of the electrical properties of proteins when exposed to anelectromagnetic field, as a possible action mechanism of the PEMF therapy.

The second study followed the morphopathological effects of the continuous andpulsed magnetic field on human cartilage explants taken from patients who had suffered atotal hip arthroplasty.

The third experiment, more relevant from a clinical point of view, is a randomized,

placebo-controlled, double blind study that evaluated the effects of PEMF on pain and algo-functional parameters resulting from the Western Ontario and McMaster UniversitiesOsteoarthritis (WOMAC) questionnaire in bilateral primary knee osteoarthritis patients who had

had unsatisfactory response to chronic nonsteroidal antiinflammatory drug therapy.

Trial 1 - The effects of pulsed electromagnetic therapy (PEMF) on the electrical

properties of the proteins in the joint fluid

Aims

The trial aimed to study the effects of PEMF on the proteins in the joint fluid usingprotein electrophoresis before and after exposure to PEMF therapy.

Methods

Ten arthrocenthesis were performed in 8 knee osteoarthritis patients and in 2seronegative spondylarthropathy patients. The joint fluid from each patient was collectedin 2 vacutainers. The first sample was sent to the laboratory, where protein elctrophoresiswas performed and the second sample was exposed to 300 Gauss intensity and 1.5 Hzfrequency PEMF for 60 minutes and protein electrophoresis was subsequently performed.

Results


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The exposure of the joint fluid to PEMF did not alter the electrical properties of theproteins in the fluid; the differences between the results of the electrophoresis were notstatistically significant in the two groups (p>0.05).

In the joint fluid of the knee osteoarthritis patients two protein fractions wereidentified (albumin and alpha-1 globulins), while in the joint fluid of the seronegativespondyalrthropathy patients 3 protein fractions were identified (albumin, alpha-1globulins and alpha-2 globulins).

A good linear relationship (determination index R2=0.74) was found between thealbumin concentration in the articular fluid and the illness duration when they wereanalyzed using the Pearsons regression line.Thus, the longer the duration of the illness,the higher the albumin concentration in the articular fluid.

Conversely, the shorter the duration of illness, the higher the concentration of alpha-1globulins (R2=0.71).

In multiple regression analysis, using as the dependent variable the proportion of

albumin in the joint fluid and as independent variables the duration of illness and thepatients age, a statistically significant variation of the albumin was found only in terms ofthe duration of the illness (p=0.008) and not with the patients age.

Trial 2 - The structural effects of the continuous and pulsed electromagnetic

field on human articular explants

Aims

The study aimed to describe the morphopathologic effects of the continuous andpulsed electromagnetic field on articular explants taken from hip osteoarthritis patientswho had suffered a total hip arthroplasty.

Methods

Ten joint cartilages were obtained from patients who had benefited from a total hiparthroplasty. The joint cartilage from the non-carrying zone of the femoral cartilage, withthe best macroscopic appearance, was detached from the bone surface by a section tangentto the bone. The cartilage was then divided into 4 equal parts and transfered into 4 sterilecontainers, filled with 10 ml of DMEM medium(Dulbeccos Modified Eagle

Medium)(Lonza), Penicyllin 100UI/ml i Streptomycin100g/ml (Lonza). A first fragment(initial group) was sent in less than 36 hours to the Pathology Laboratory of the CFHospital Cluj-Napoca, where the safranin-orange staining was performed. The other 3fragments were incubated in less than 6 hours from the operation at 370C for 4 days.

The second fragment was used as control, the third fragment was treated withcontinuous electromagnetic field (the CMF group), at an intensity of 0.1 mT for 3 hours aday for four days and the fourth fragment (the PEMF group) was exposed to 1.5 Hz and 30mT PEMF for 3 hours a day. After four days, the three fragments were alsomorphopathologically analyzed using the safranin orange staining.

The hystological evaluation was performed by two independent observers using themodifyed Mankin score. In this grading system of the osteoarthritis cartilage, 0-6 points are


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attributed to extracellular matrix lesions, 0-3 points to chondrocyte abnormalities, 0-4points to the progressive reduction in the safranin-orange staining intensity and 0-1 pointsto the loss of integrity in the cartilage-bone border.

Results

The modified Mankin score was aggravated in the control group when compared tothe initial group (9.5 vs 8.5). In the CMF group, the score was lower in comparison to that inthe control group (9.05) while in the PEMF group, the score was even lower than that in theinitial group (8.7). Nevertheless, the differences found between the groups were notstatistically significant; the lowest p value was found when the control and the PEMF groupwere compared (p=0.27).

The modified Mankin score variations in the four groups were due especially to thechanges in the subscore of the safranin orange staining. In the control group the score washigher than the initial one (2.95 vs 2.45). In the continuous magnetic field group thesafranin orange staining score was lower than in the control group (2.65) and in the pulsed

electromagnetic field group it was even lower than in the initial group (2.45). Still, thedifferences were not statistically significant; the lowest p value was found when the controland PEMF group were compared (p=0.14) and when the initial and control groups werecompared (p=0.17).

Trial 3 - Effects of focalized pulsed electromagnetic field therapy in knee

osteoarthritis patients, a randomized, placebo-controlled study

Aims

The trial aimed to study the effects of low frequency (1.5 Hz) medium intensity (30mT) pulsed electromagnetic field (PEMF) therapy in bilateral primary knee osteoarthritis

patients with a radiologic Kellgren-Lawrence score 1 and a visual analog scale of pain 4,despite the chronic use of nonsteroidal antiinflamatory and chondroprotective drugs.Methods

A number of 70 consecutive bilateral primary knee osteoarthritis patients wererandomized into two groups: an active group and a placebo group in a 1:1 ratio. Thepatients in the placebo group were treated with local ultrasound therapy (0.5W/cm 2),peloids (Techirghiol peloid), and a form of continuous magnetic field similar in intensity tothe Earth magnetic field for 15 minutes a day. The active group benefited from localultrasound therapy (0.5W/cm2), peloids and pulsed electromagnetic field therapy with afrequency of 1.5 Hz and an intensity of 30 mT for 15 minutes a day. The treatment duration

was 10 days in both groups. The blood pressure was recorded in each patient daily beforeand after exposure to PEMF. The patients were asked to report any adverse effects duringthe PEMF therapy.

The patients who were included in the study had clinical symptoms of bilateralprimary knee osteoarthritis according to the American Rheumatology Association, withradiologic modifications on the Kellgren-Lawrence scale with a score higher than or equalto 4 on the visual analog pain scale (VAS). Secondary knee osteoarthritis patients, bearers


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of metallic implants, pacemakers, locally and generally infected patients, individuals withtumors or recent hemorrhagic diathesis (in the last year), heart failure, hepatic or renalinsufficiency patients were excluded.

Results

Out of a total of 70 patients included, 65 completed the study (32 in the active groupand 33 in the placebo group). After the 10 days of treatment, there was a significantimprovement in the visual analog scale (VAS) of pain and in the WOMAC score in both

groups compared to the initial evaluation (p0.05). No statistically significantimprovement in the two parameters in the active versus placebo groups was found

(p0.05).However, in a subgroup analysis, after the exclusion of the patients with advanced

knee osteoarthritis with a Kellgren-Lawrence radiologic score of 3 and 4, the patientstreated with PEMF had superior improvement in the pain VAS and the WOMAC score

(p0.05).

The blood pressure at the end of the treatment was not significantly different fromthat recorded in the beginning in both study groups.

The frequency of adverse reactions reported by the patients was 9% in each group.Temporary aggravation of the pain was reported by 2 patients in the placebo group (6%)and by 2 patients in the active group. Worsening of the pain appeared at the beginning ofthe treatment and interruption of treatment was not necessary.

General conclusions

1. Low frequency medium intensity pulsed electromagnetic field therapy did notchange the electrical properties of the proteins in the articular fluid after the end

of exposure2. The proportion of albumin in the joint fluid of knee osteoarthritis andseronegative spondylarthropathy patients linearly correlates with the duration ofillness, while the alpha-1 globulin proportion inversely correlates with theduration of the joint illness.

3. The joint fluid protein electrophoresis is a promising, cost-effective and accessiblemethod that can offer information about the articular illness duration, intensity ofthe intraarticular inflammation and it could also orient the clinical diagnosistowards degenerative or inflammatory rheumatism, but additional studies areneeded in this respect.

4. The exposure of human articular explants for 3 hours a day for four days to a lowintensity (0.1mT) continuous electromagnetic field and to a low frequency (1.5Hz) medium intensity (30 mT) pulsed electromagnetic field did not significantlychange the modified Mankin score in the histological analysis of the cartilageswith the safranin-orange staining.

5. However, a tendency towards improvement of the modified Mankin score wasfound in the pulsed electromagnetic field group versus the control group, on the


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expense of an increase in the intensity of the safranin orange staining in thepericellular and territorial matrix of the articular cartilage.

6. Physical therapy with ultrasound and peloids is effective in reducing the pain andthe WOMAC score in knee osteoarthritis patients with a radiologic Kellgren-Lawrence score 1, a visual analog scale of pain 4 and an unsatisfactory responseto the nonsteroidal antiinflammatory drug and chondroprotective therapy.

7. Low frequency (1.5 Hz) medium intensity (30 mT) pulsed electromagnetic fieldtherapy provided additional benefit to these therapies, significantly diminishingthe pain and the WOMAC score in early and moderate knee osteoarthritis patients(Kellgren-Lawrence radiologic score 1 and 2).

8. The focused pulsed electromagnetic field therapy did not significantly change theblood pressure.

9. The focused low frequency (1.5 Hz) medium intensity (30 mT) pulsedelectromagnetic field was well tolerated and did not have notable adverse

reactions.

Efectele Terapiei Cu Camp Magnetic Pulsatil La Pacientii Cu Gonartroza

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