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Completed

NCT Number: NCT04830254

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation(TENS) device

Device

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.

Other names: TENS

Primary outcomes

  1. Red cell distribution width (RDW)

    Time frame: change from baseline to after 12 weeks

    Peripheral venous blood samples were obtained from each patient.

  2. Mean platelet volume(MPV)

    Time frame: change from baseline to after 12 weeks

    Peripheral venous blood samples were obtained from each patient.

  3. Ankle peak systolic velocity (APSV)

    Time frame: change from baseline to after 12 weeks

    is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography

  4. Arterial diameter

    Time frame: change from baseline to after 12 weeks

    Diameter of lower limb arteries measured by doppler ultrasonography

Secondary outcomes

  1. Actual claudication distance

    Time frame: change from baseline to after 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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