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Clinical Trial Summary

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 (


Clinical Trial Description

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. 1. Does pulsed electromagnetic field will have an effect on posterior tibial artery diameter using Doppler ultrasound in patients with PAD and suffering from intermittent claudication ? 2. Does pulsed electromagnetic field will be effective in improving the claudication pain time and distance , maximal walking free time and distance in patients with peripheral arterial disease ? 3. Does pulsed electromagnetic field will be effective in improving the ABI ( ankle brachial pressure index in patients with peripheral arterial disease? 4. Does non invasive pulsed electromagnetic field (PEMF) will be better than supervised treadmill walking exercise in management of intermittent claudication in patients with peripheral arterial disease ? 5. Are there differences between PEMF and supervised treadmill walking exercise in improving exercise performance and hemodynamic parameters in patients with peripheral arterial diseases ? Purpose of the study Purposes of this study will be the following 1. To evaluate the therapeutic efficacy of pulsed electromagnetic field On walking parameter (on Maximum walking Free time , Maximum walking Free distance, Claudication pain time , Claudication pain distance ) in management of intermittent claudication in patients with PAD . 2. To evaluate the effect of non invasive pulsed electromagnetic field on ABI (ankle brachial pressure index) in patients with PAD suffering from intermittent claudication. 3. To investigate the effect of non invasive PEMF on Posteriot Tibial Artery Diameter in patients with PAD suffering from intermittent claudication. 4. To evaluate the effect of supervised treadmill walking exercise in managemet of intermittent claudication in patients with PAD 5. to compare between the efficacy of non invasive pulsed electromagnetic field versus supervised treadmill walking exercise ( on distance and time till reaching maximum tolerated pain of intermittent claudication and also the efficacy on ankle brachial pressure index , pain intensity level ) in patients with peripheral arterial diseases suffering from intermittent claudication 6. To gain knowledge about Non Invasive Pulsed Electromagnetic Field application and implementation in physical therapy field 7. To share in designing an ideal protocol for the treatment of intermittent claudication in patients with PAD ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04621097
Study type Interventional
Source Cairo University
Contact
Status Active, not recruiting
Phase N/A
Start date December 15, 2018
Completion date May 15, 2021

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