Clinical trial NCT04621097: Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease
Official title: Effect of Pulsed Electrmagnetic Field Versus Treadmill Training on Walking and Haemodynamic Parameters in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A : Pulsed electromagnetic field PLUS medications group B : Treadmill Training Plus Medications group C :medications only
Primary purpose: TREATMENT

Brief 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 (

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Both genders are allowed to participate in the study .
* The age range of patients will be from 45-65 years
* All patients are diagnosed with PAD since at least ( 6 months to1 year) and suffer from IC
* All patients will be suffering from moderate degree of pain in the calf according to claudication pain scale.
* ABPI for all patients will be ranged from 0.65 to 0. 9
* All patients are medically and psycholigically stable .
* Only ambulant patient without any aids will be selected
* All patients are non smokers

Exclusion Criteria:

* Patients with Severe grades of intermittent claudication that produce ischemic pain at rest
* Presence of claudication symptoms less than 2 months
* Patients with fontaine stage I PAD (asymptomatic)
* Patient with fontaine stage III PAD (leg pain at rest )
* Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
* Patients who are unable to walk on the treadmill or unable to attend sessions at the physical therapy department at APH , 3 times a week .
* Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure) will be excluded from this study.
* Patients with neurological problems that cause leg pain .
* Patients with active malignancy will be excluded from study Patients with acute tuberculosis, soft tissue infection, cellulities, hyperthyroidism, acute viral diseases, Patients with pace makers will be excluded from the study Patients with ischemic ulcers or gangrenes
* Patients with marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD).
* Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study
* Patients with musculoskeletal disorders ( Diagnosed with severe osteoporosis , severe osteoarthritis or joint replacement )

Primary outcomes:
measure: Ankle brachial pressure index ( ABPI )
timeFrame: 8 weeks
measure: Posterior Tibial Artery Diameter ( PTA )
timeFrame: 8 WEEKS
Secondary outcomes:
measure: claudication onset time (COT) or distance
timeFrame: 8 WEEKS
measure: a peak walking time (PWT) or peak walking distance.
timeFrame: 8 WEEKS
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
affiliation: Cairo University
name: reham raafat, phd
role: PRINCIPAL_INVESTIGATOR
References: