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NCT Number: NCT01894997

A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow, in both a young and an older population.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Ireland, Galway

Galway, Ireland

About this study

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Free from any known illness
  • Between 18 and 40 years of age
  • Between 55 and 65 years of age

Exclusion criteria

  • History of heart/respiratory problems
  • Pregnancy
  • Presence of implants, including cardiac pacemakers and orthopaedic implants
  • History of neurological disorder
  • History of severe arterial disease or known dermatological problems

Treatment and study plan

Neuromuscular Electrical Stimulator

Device

AV Impulse System Model 6000

Device

Other names: Intermittent Pneumatic Compression Device

Primary outcomes

  1. Blood flow measurements from the lower limb

    Time frame: Two hours (plus or minus half an hour)

    Doppler measurements will be taken for each of the interventions.The measurement site of interest is the popliteal vein, located at the back of the knee. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow will be recorded. 3 measurements of each will be taken per intervention. No measurements will be taken within the first minute of the intervention.

Secondary outcomes

  1. Blood pressure

    Time frame: Two hours (plus or minus half an hour)

    Blood pressure will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.

  2. Heart rate

    Time frame: Two hours (plus or minus half an hour)

    Heart rate will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Collaborators

  • Galway Clinic
  • Irish Research Council

Registry information

Official study title

A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Sep 3, 2014

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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