CLINICAL TRIALS

VLADIMIR REGIONAL STATE PUBLIC HEALTH ESTABLISHMENT

        « REGIONAL CLINICAL HOSPITAL »

41, Sudogodskoe highway, 600023, Vladimir, ph./fax 4922-32-61-79

E-mail: vladokb@vtsnet.ru

No.869 of 13.05. 2009

 

« Experience of "АLMAG - 01" device application for travelling pulsed

magnetic field treatment

 

ALMAG -01 device was applied for diabetes mellitus complications - diabetic foot in hospital physiotherapeutic department treatment from October 2005 till November 2008.

Diabetic foot syndrome is a complex of anatomy-functional changes which can be met in the various form at 30-80 % of patients with diabetes.

The lower extremities amputation in of this group of patients takes place 15 times more often, than in rest group of population. According to data of number of authors the big number ( 50 – 70% ) of all lower extremities amputations is the patients with diabetes mellitus.

In pathogenesis of diabetic foot syndrome development there are three main major factors taking the leading place:

-        neuropathy;

-        lower extremities arteries lesion;

-        infection

 

Last factor, as a rule, is a concomitant one regarding to the first two forms. Proceeding from predominance of both neuropathy changes or peripheral blood-flow abnormalities there are two main clinical forms of diabetic foot syndrome:

- neuropathy;

- isch(a)emic;

Alongside with diabetes mellitus lower extremities lesion two basic forms there is the third one:

- mixed (neuro- isch(a)emic).).

Neuropathy form can be followed by somatic and vegetative nervous system lesion with lower extremities arterial segments intact. Neuropathy can result in foot lesion of three types as follows:

- neuropathy sore (ulcer );

- osteoarthropathy (further on with the neurogenic development

- neuropathy edema..

 

The ischemic form is developing as a consequence of lower extremities arteries atherosclerotic affection resulting in both main blood-flow abnormality as well as neuropathy changes. However decrease or complete absence of pulsation in feet and shins, cold extremities while in palpation, the pain symptomatology as well as sore defects individual localization similar to acral necrosis allow to differentiate both neuropathy and mixed (neuro- isch(a)emic) forms of feet affection.

With the count of multifactorial etiopa thogenesis and the diversification of diabetic foot clinical symptoms, there is an urgency of given pathology new rehabilitation methods development with the purpose to increase treatment clinical efficiency.

In an arsenal of applied treatment methods applied for given disease the important place is given to the application of natural and preformed physical factors making both local and general (systemic) effect , producing adaptive reactions, activization of an organism reserve potentialities directed to pain syndrome cupping (stopping) , vascular abnormalities correction, improvement of nervous system functional state.



Numerous clinical trials testify to low-frequency pulsed electromagnetic fields wide medical potentialities and high efficiency. Low-frequency pulsed electromagnetic fields local exposure makes obvious anti-inflammatory, spasmolytic, analgetic , trophic-regenerative effect. ( Prato p.8) Magnetic field improves both perineural sheath microcirculation , myelin sheath trophic function, facilitates normalzation of neuro- muscular apparatus functional state. Technical feasibility of the majority of modern physiotherapeutic devices producing low-frequency magnetic field is restricted regarding to area of their action on all pathogenetic and clinically important affected areas. In connection with this fact , the availability of remote strip - line inductors (coils assembly exposure unit) of " АLMAG -01” device provides the possibility to make action in turn on the patient body big area thus increasing efficiency of magnetotherapy application for the given nosology treatment.

In Vladimir Regional Clinical Hospital there were carried out trials of low-frequency travelling magnetic field, generated by "АLMAG-01" physiotherapeutic device, action on patients with syndrome of diabetic foot (the conscience of diabetes mellitus I-st type). " АLMAG-01" device is manufactured in JSC «Yelama Instrument-Making Enterprise», Russia.

The trial purpose was to study "АLMAG-01" low-frequency travelling magnetic field physiotherapeutic device application expediency and efficiency for patients with diabetic foot syndrome and neuro- isch(a)emic forms of diabetes mellitus I-st type.

Table 1 "АLMAG-01" device efficiency clinical trial scheme.

 

1-st day

1st -10th day

10th day

Clinical status

X

X

X

Pain visual –analog scale

X

 

X

Blood clinical analysis

X

 

X

Blood biochemical analysis (blood sugar level)

X

 

 

Urine analysis

X

 

X

Lower extremities rheovasography

X

 

X

Electrocardiogram (ECG)

 

 

 

Magneto therapy course

X

X

X

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical trial was carried out within 3 months. All patients were divided into 2 groups according to age, disease duration, cliniсal-neurologic status principal. The Ist group (104-persons) – patients with syndrome of diabetic foot taken «АЛМАГ-01» device physio-therapy action on lumbosacral area according to  cross (transverse) and line technique over both lower extremities front surfaces.

 

The second control group (98 person) - patients with diabetic foot clinical symptoms which did not take magneto-therapy procedures on lumbar area and lower extremities

Within the observation period the patients took the basic treatment.

Within the observation period vascular medical preparations hadn`t been taken.

Treatment procedure:

The patients of 1st group took the exposure by " АLMAG-01 " low-frequency travelling magnetic field physiotherapeutic device imposing remote strip - line inductors ( coils exposure assembly-unit) on lumbosacral area according to  transverse and line technique over the both lower extremities front surfaces. Treatment procedure exposure time - 7 min on each area. Magnetic field exposure mode: frequency - 6,25 Hz, magnetic induction amplitude value - 20 mTl. Treatment course includes 10 daily procedures.

Patients clinical characteristic:

Under observation there were 202 patients with diabetic foot clinical symptomes,  disease duration - from 0,5 to 8 years. Among patients there were 88 (57,5 %) men and 114 (42,5 %) women at the age of 44 - 72 years old , patients average age - 58 years old.

26 patients with disease duration from 0,5 to 1 year; 112 patients - from 1 to 3 years , 14 patients - from 3 to 6 years, 64 patients - .from 5 to 8 years

Lower extremities rheovasogram analysis revealed the fact that 47 % of patients had vasomotor spasm features as follows: decrease of reowave amplitude, length of anacrotic phase time , shift dicrotic peak at the top of curve, decrease of renography index (RgI) and increase of peripheric resistance parameter - dicrotic index (DcI) indicating  fine vessels` increased tone.

Disease clinical picture: complaints of pains, cold, numbness of the lower extremities. At examination there were observed vegetative disturbances, as: change both skin and nails colour, skin dryness , foot hyperkeratosis and pastose.

 

Trials results:

Upon "АLMAG-01" device treatment course termination there were carried out subjective and objective assessment of treatment efficiency. In the whole treatment procedures tolerance was good. As a result of treatment most of the patients marked the improvement of general health state , there were positive changes of disease subjective and objective clinical picture. Efficiency analysis (both improvement of patients health well-being or disease examined parameters) has shown the obvious clinical effect in 59 % of cases.

Result of carried out treatment had shown ( visual analog scale data measured in sm): intensity of pain syndrome decrease from 4,8 ±1,5  to 2,1 ±1,6 points, whereas in control group the decrease came to 3,5±0,5 points.

 In the basic group there was marked the tendency both of systolic and, to a great extent, diastolic arterial pressure decrease that was probably explained by the effect of peripheric vasodilation as a result of magnetic field exposure (table 2).

 

Table 2. Llumbar spine dorsopathy disease patients arterial pressure dynamic.

 

 

Systolic arterial pressure (SAP)

Diastolic arterial pressure  (DAP)

 

Before

After

Before

After

 

treatment

treatment

treatment

treatment

1st group

139±4,6

123±3,6*

87,8±4,4

68,4±6,6*

2nd group

136±6,5

129±7,8

86,6±7,3

82,2±7,4

 

 

 

 

 

 

 

 

 

            *- p <0,05

Rheovasographic (RVG) trials  had shown "АLMAG" device favorable effect on patients regional hemodynamics improvement both of rheography curves form and structure and RVG quantity indexes However these positive changes basically concerned patients with vasospastic type of peripheric circulation. There was marked the increase of initially reduced rheography index (RgI) (57 % of patients with initially decreased RGI) indicating both the increase of lower extremities pulse blood filling ; decrease of fine vessel tone as decrease of initially high values of dicrotic index (DcI) (64 % of patients), reduction of  DAPI  testifying the improvement of venous outflow (71 % of patient).

In the basic group 28 % of patients with hypotonic type had evident reduction of initially increased RgI, DAPI and increase of initially reduced DcI , whereas 45 % of patients had increase of RgI probably as a result of magnetic field vasodilating effect.

Table 3

Dynamic of lower extremities rheovasography index on the background of «ALMAG -01» device magneto-therapy.

 

Patient groups

Rheovasographic (RVG) indexes

Values

1st group (number of patents -104)

RgI (Оm)

0,49±0,07*

0,74±0,05

DcI (%)

43,5±1,9*

36,2±1,7

DAP (%)

39,7±2,6

35,8±1,8

2nd group (number of patents - 98)

RgI (Оm)

0,48±0,08

0,62±0,1

DcI (%)

43,9±1,8

39,4±1,9

DAP (%)

40,2±1,6

39,2±1,7

*-Р<0,05; Numerator - parameters before treatment, denominator - parameters after treatment

Thus, " ALMAG-01 "device magnetic field  treatment for patients with diabetic foot consequence of neuropathy sore ( ulcer) clinical symptoms facilitated both decrease of pronounced pain syndrome and sensitive disturbancies; improvement of peripheric hemodynamics parameters that was followed by the change of affected extremities skin colour, acceleration of ulcerative defect healing.

 

     Conclusion

There were revealed positive subjective and objective changes on the background of                " АLMAGГ-01 " device pulsed travelling magnetic field physiotherapy action on lumbar spine and lower extremities. Disease clinical picture as a result pulsed travelling magnetic field physiotherapy application was as follows: improvement of patients` state general well-being, moderate analgesic  and spasmolytic effect, moderate hypotensive action with full absence of by-effects. Vasodilating effect as a result of " АLMAGГ-01 " device pulsed travelling magnetic field physiotherapy application for the patients with neurovascular changes of diabetic foot , as a consequence of diabetes mellitus of 1st type complication,  represents itself the great interest and requires further detailed study regarding to its wider application in complex treatment for patients with nosological form.

 

Thus, taken trials results allow to recommend the application of «ALMAG-01» device pulsed travelling magnetic field physiotherapy in complex treatment for patients with diabetic foot.

 

 

Vladimir region health establishment,

The head of physiotherapeutic department,

The leading physiotherapy expert                   L.A.Chernyavskaya.

  

Back to the list

Follow us

share it

8