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Completed

NCT Number: NCT01886612

A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow

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.

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Key information

Age range

18 year–40 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.

Both IPC and 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 lower limb haemodynamics.

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.

Exclusion criteria

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

Treatment and study plan

Duo-STIM 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: An hour and a half (plus or minus half an hour)

    Doppler measurements must be taken for each of the interventions. The measurement site of interest is the popliteal vein, located at the lateral aspect of the knee, below the sapheno-popliteal junction. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow are required. A minimum of 3 measurements per intervention is required for rigor. Do not take any measurement within the first minute of the intervention

Secondary outcomes

  1. Blood Pressure

    Time frame: An hour and a half (plus or minus half an hour)

  2. Heart Rate

    Time frame: An hour and a half (plus or minus half an hour)

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 Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Haemodynamics

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Aug 2, 2013

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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