Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients

Study Overview
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Brief Summary
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Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.

Detailed Description
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The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.

Official Title
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Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Transcutaneous Electrical Nerve Stimulation(TENS) device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral Leriche-Fontaine stage-II PAD Both sexes Aged 50 to 60 years Outpatients Clinically stable Sedentary Not participating in any physical activity last 3 months Exclusion Criteria: Walking disorders related to orthopedic or neuromuscular disease Renal insufficiency requiring dialysis (Renal diseases) Known and documented myopathy Progressive cancer Associated progressive disease causing a deterioration in general health Participation in another research protocol Skin disorder making it impossible to use TENS Absolute contraindication to physical activity Presence of a pacemaker/defibrillator

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group(A)<br>Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks. | Device: Transcutaneous Electrical Nerve Stimulation(TENS) device<br>* The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.<br>* Other names: TENS;|
| Sham Comparator: Control group(B)<br>The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation | Device: Transcutaneous Electrical Nerve Stimulation(TENS) device<br>* The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.<br>* Other names: TENS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red cell distribution width (RDW) | Peripheral venous blood samples were obtained from each patient. | change from baseline to after 12 weeks | 
| Mean platelet volume(MPV) | Peripheral venous blood samples were obtained from each patient. | change from baseline to after 12 weeks | 
| Ankle peak systolic velocity (APSV) | is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography | change from baseline to after 12 weeks | 
| Arterial diameter | Diameter of lower limb arteries measured by doppler ultrasonography | change from baseline to after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual claudication distance | Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes. | change from baseline to after 12 weeks |