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my study is to determine the effect of pulsed electromagnetic field versus treadmill training in managemet of intemittent claudication in peripheral arterial disease
there is a lack of interventions that improves local peripheral blood circulation in ischemic lower limbs . (PEMFs) are a non-pharmacological and non-invasive treatment that can be applied on the affected body part, which penetrates through skin and reaches target tissues . However, there have been few clinical studies reporting the effects of PEMFs on hemodynamic response in people with PAD (
Statement of the problem :
Is there any Difference between Pulsed ElectroMagnetic Field and Supervised Treadmill walking exercise on improving exercise performance and hemodynamic parameters in patients with peripheral arterial disease
The use of pulsed electromagnetic field (12hz to50hz) in improving microcirculation , microvascular blood perfusion , stimulation of nitric oxide release and stimulating angiogensis has introduced a new dimension to the physical therapy field , to the available knowledge puplished , there is no literature about analgesic and microcirculatory effect of PEMF on circulation improvement in patients with PAD , therefore the proplem of the study will be stated in a questionnary form for answering the following aspects : ( Chalidia B. etal 2011)
Significance of the study :
Treatment of PAD is critically important in order to minimize the risk of long term disability and improve quality of life . The need of this study developed from the lack in published studies about the effect of pulsed electromagnetic field in management of peripheral arterial diseases and also there was no available previous trials comparing the effect of PEMF and treadmill exercise on walking parameters , posterior tibial artery diameter and ABI on patients with PAD
the results of this study may provide an easy non pharmacological modality for dealing with such cases . Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of intermittent claudication in patients with peripheral arterial diseases. In Addition, increased knowledge of the influence of PEMF on microvascular function may have significant therapeutic potential and may be valuable for the intervention of diabetes-related lower limb vascular occlusion and amputation in the clinic.
Purpose of the study Purposes of this study will be the following
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulsed electro magnetic field | Experimental | 30 patients will receive the physical therapy program in form of low frequency pulsed electro magnetic field application. with frequency 15hz, and low intensity with flux density of 20 Gauss (2mT), in pulse duration 200 usec , pulsed rectangular pulses for 60 min is applied to the dorsal surface of lower leg , ankle and foot in addition to their regular medications prescribed , 3 times per week for 8 week |
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| Treadmilltraining | Experimental |
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| medications | Placebo Comparator | It includes 20 patients who will not receive any physiotherapy intervention. They will receive medical treatment only and will act as a control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed electromagnetic field | Device | it is a device for magnetotherapy and it is one of the most recent noninvasive physical therapy modality which is used in multiple physical therapy fields . it consist of an appliance, motorized bed and solenoid . the appliance must be connected to electrical supplying 230 =10% at a frequency of 50 or 60 HZ with earth connection . the intensity and spatial lay out of the generated magnetic field depend on the type of solenoid used |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle brachial pressure index ( ABPI ) | it will be measured by doppler ultrasound | 8 weeks |
| Posterior Tibial Artery Diameter ( PTA ) | it will be measured by doppler ultrasound | 8 WEEKS |
| Measure | Description | Time Frame |
|---|---|---|
| claudication onset time (COT) or distance | it will be measured by Graded Treadmill Exercise Testing | 8 WEEKS |
| a peak walking time (PWT) or peak walking distance. | it will be measured by Graded treadmill exercise testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| reham raafat, phd | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy Cairo University | Cairo | Egypt |
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within 6 months
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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group A : Pulsed electromagnetic field PLUS medications group B : Treadmill Training Plus Medications group C :medications only
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| treadmill training | Other | supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes . |
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| Medication | Drug | regular medications |
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| 8 WEEKS |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |